Gossamer Bio
Sr. Manager/ Associate, Director, GMP Quality Assurance
Gossamer Bio - San Diego, California, United States, 92101
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Overview
Sr. Manager/ Associate, Director, GMP Quality Assurance
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. Provide 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.
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. Provide 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.