Gossamer Bio
Sr. Manager/ Associate, Director, GMP Quality Assurance
Gossamer Bio, San Diego, California, United States, 92189
Sr. Manager/ Associate, Director, GMP Quality Assurance
SUMMARY The Sr. Manager/ Associate Director of GMP Quality Assurance will be responsible for quality oversight for GMP activities to support third party manufacturing, packaging, testing, and supply of drug substance and drug products for use in clinical and commercial operations. Manage batch record review, product investigations, deviations, complaints, change control, and other actions related to GMP activities, as required. They will review internal and external documentation for compliance with established standards and regulations. Provide input as necessary into the review and establishment of product specifications and GMP related SOPs. Collaborate with cross functional team members and support Gossamer GMP activities. ESSENTIAL DUTIES AND RESPONSIBILITIES Review and approval of manufacturing release testing and stability batch records for compliance Evaluate, review and approve change controls, GMP investigations and deviations. Review of Quality Agreements with contract manufacturers. Review and approve master batch records, risk assessments, methods, specifications, and validation protocols and reports. Review and assess specifications, reference materials and test results. Provide quality oversight of process and method transfer/validation and activities Conduct and support GMP audits and internal audits as needed Gather quality metrics, supporting and/or participating in quality management review. Review and update GMP related SOPs and policies Serve as QA representative on departmental and project team(s) representing CMC Quality. Work across departments and with contract manufacturers to ensure readiness for regulatory inspections and participate in inspections as needed. Provie input into the operating budget for the GMP QA function. Communicate and promote a culture of quality and operational excellence. Effectively represent Quality to regulatory agencies. Maintain current knowledge and full understanding of compliance and regulatory requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients and drug products. Data Privacy Work as part of cross-functional teams to advance a strong and mature data privacy and data protection program across the company, including key vendors and third-party providers JOB QUALIFICATIONS Education, Certifications, Experience Bachelor's degree in relevant scientific discipline is required. An advanced degree is preferred. 10+ years of relevant experience in the area of GMP quality assurance in the pharmaceutical industry with at least 2 years in a managerial/leadership capacity Knowledge, Skills and Abilities Significant hands-on experience with small molecule drug development in a biopharmaceutical company. Extensive knowledge of US cGMP compliance regulations and industry practices, as well as EU GMP requirements. Ability to critically evaluate and troubleshoot complex problems and attention to detail. Strong leadership and management skills. Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management. Excellent verbal and written communication skills. Ability to manage multiple priorities and aggressive timelines. SPECIAL WORKING CONDITIONS Office environment / Domestic and International travel up to 25% may be necessary Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment. The expected salary range for this position based on the primary location in California is $165,000 to $200,000 . Actual pay will be determined based on experience, qualifications, geographical location and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below: Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/careers-culture/who-we-are/ California Consumer Privacy Act (CCPA) Notice for California Residents: This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com , because Controller wishes to evaluate your candidacy for employment at Controller. Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at privacy@gossamerbio.com .
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority. Create a Job Alert Interested in building your career at Gossamer Bio? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Location (City) * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Employment Title * Select... Start date year * End date month * Select... End date year * Current role Education Degree * Select... Will you now or in the future require sponsorship for employment visa? Select... LinkedIn Profile Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Gossamer Bio’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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SUMMARY The Sr. Manager/ Associate Director of GMP Quality Assurance will be responsible for quality oversight for GMP activities to support third party manufacturing, packaging, testing, and supply of drug substance and drug products for use in clinical and commercial operations. Manage batch record review, product investigations, deviations, complaints, change control, and other actions related to GMP activities, as required. They will review internal and external documentation for compliance with established standards and regulations. Provide input as necessary into the review and establishment of product specifications and GMP related SOPs. Collaborate with cross functional team members and support Gossamer GMP activities. ESSENTIAL DUTIES AND RESPONSIBILITIES Review and approval of manufacturing release testing and stability batch records for compliance Evaluate, review and approve change controls, GMP investigations and deviations. Review of Quality Agreements with contract manufacturers. Review and approve master batch records, risk assessments, methods, specifications, and validation protocols and reports. Review and assess specifications, reference materials and test results. Provide quality oversight of process and method transfer/validation and activities Conduct and support GMP audits and internal audits as needed Gather quality metrics, supporting and/or participating in quality management review. Review and update GMP related SOPs and policies Serve as QA representative on departmental and project team(s) representing CMC Quality. Work across departments and with contract manufacturers to ensure readiness for regulatory inspections and participate in inspections as needed. Provie input into the operating budget for the GMP QA function. Communicate and promote a culture of quality and operational excellence. Effectively represent Quality to regulatory agencies. Maintain current knowledge and full understanding of compliance and regulatory requirements (FDA, EMA, MHRA, etc.) related to the manufacture of active pharmaceutical ingredients and drug products. Data Privacy Work as part of cross-functional teams to advance a strong and mature data privacy and data protection program across the company, including key vendors and third-party providers JOB QUALIFICATIONS Education, Certifications, Experience Bachelor's degree in relevant scientific discipline is required. An advanced degree is preferred. 10+ years of relevant experience in the area of GMP quality assurance in the pharmaceutical industry with at least 2 years in a managerial/leadership capacity Knowledge, Skills and Abilities Significant hands-on experience with small molecule drug development in a biopharmaceutical company. Extensive knowledge of US cGMP compliance regulations and industry practices, as well as EU GMP requirements. Ability to critically evaluate and troubleshoot complex problems and attention to detail. Strong leadership and management skills. Excellent interpersonal skills with the ability to effectively interact with and influence different functional groups at all levels of management. Excellent verbal and written communication skills. Ability to manage multiple priorities and aggressive timelines. SPECIAL WORKING CONDITIONS Office environment / Domestic and International travel up to 25% may be necessary Gossamer Bio is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants and complies with all applicable national, state and local laws governing nondiscrimination in employment. The expected salary range for this position based on the primary location in California is $165,000 to $200,000 . Actual pay will be determined based on experience, qualifications, geographical location and other job-related factors permitted by law. This position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. This position also qualifies for the benefits as listed below: Gossamer Bio offers highly competitive benefit plans and programs, including medical, dental and vision insurance, 401(k) and 401(k) matching , long-term incentive plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. For additional general information on Company benefits, please visit https://www.gossamerbio.com/careers-culture/who-we-are/ California Consumer Privacy Act (CCPA) Notice for California Residents: This notice is to notify you that personal data about you has been collected by Gossamer Bio (“Controller”), which is located at 3115 Merryfield Row, Suite 120, San Diego CA 92121 and can be contacted by emailing privacy@gossamerbio.com , because Controller wishes to evaluate your candidacy for employment at Controller. Your personal data was either obtained from publicly available sources (e.g. LinkedIn) or provided to Controller by someone who referred you for potential employment. Controller’s Privacy team can be contacted at privacy@gossamerbio.com .
Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of Regulation (EU) 2016/679 (General Data Protection Regulation) and the California Consumer Privacy Act (CCPA) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data has been shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR and CCPA, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have to right to data portability. In addition, you may lodge a complaint with a supervisory authority. Create a Job Alert Interested in building your career at Gossamer Bio? Get future opportunities sent straight to your email. Apply for this job
* indicates a required field First Name * Last Name * Email * Phone * Location (City) * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Employment Title * Select... Start date year * End date month * Select... End date year * Current role Education Degree * Select... Will you now or in the future require sponsorship for employment visa? Select... LinkedIn Profile Voluntary Self-Identification
For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file. As set forth in Gossamer Bio’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law. If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Select... Voluntary Self-Identification of Disability
Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Voluntary Self-Identification of Disability Form CC-305 Page 1 of 1 OMB Control Number 1250-0005 Expires 04/30/2026 Why are you being asked to complete this form?
We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years. Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability?
A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.
Disabilities include, but are not limited to: Alcohol or other substance use disorder (not currently using drugs illegally) Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS Blind or low vision Cancer (past or present) Cardiovascular or heart disease Celiac disease Cerebral palsy Deaf or serious difficulty hearing Diabetes Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders Epilepsy or other seizure disorder Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome Intellectual or developmental disability Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD Missing limbs or partially missing limbs Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS) Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities Partial or complete paralysis (any cause) Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema Short stature (dwarfism) Traumatic brain injury
Disability Status Select... PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.
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