Azurity Pharmaceuticals
Overview
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity\'s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Responsibilities
Maintain a robust and inspection-ready Quality Management System (QMS). Oversee the validation, integrity, and ongoing compliance of electronic quality systems. Ensure procedures are appropriately authored, reviewed, approved, and updated. Manage the Documentation Management System and ensure all controlled documents meet regulatory standards. Maintain compliant training records and quality documentation in alignment with regulatory expectations. Lead the development and implementation of a GxP training program for relevant personnel. Support the development and tracking of quality metrics and key performance indicators (KPIs). Provide governance and facilitate Quality Risk Management processes, including timely escalation to senior leadership. Lead continuous improvement initiatives for quality systems and processes. Oversee Change Control processes to ensure systematic and compliant change implementation. Manage the Product Quality Review (PQR) and Product Complaint programs, including investigations and Corrective and Preventive Actions (CAPAs). Oversee the Computer System Validation (CSV) program ensuring compliance with 21 CFR Part 11 and EU Annex 11. Serve as a primary quality compliance liaison with cross-functional departments, including Medical Affairs, Regulatory Affairs, and IT. Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field. Minimum of 10 years of experience in quality assurance, with at least 5 years in a leadership role within a GxP-regulated environment. In-depth knowledge of global regulatory standards (FDA, EMA, ICH, etc.) for quality systems. Strong expertise in risk management, product complaints, change control, and CSV. Proven ability to communicate complex compliance topics clearly to stakeholders at all levels. Excellent leadership, project management, and problem-solving skills. Physical & Mental Requirements
Must be able to sit for long periods of time While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear May occasionally climb stairs and/or ride elevators The employee must occasionally lift and/or move up to 25 pounds Employee must be able to manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required Benefits We Offer
Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent. Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan. Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you. Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of. Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions. Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%. Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date. Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge. Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays. Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications. Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work. The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here. The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU). Apply for this job
indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School * Select... Degree * Select... Select... Select... Start date year End date year LinkedIn Profile Website Prior to employment, you must consent to a background check and drug screen. Please acknowledge this requirement. * Select... What are your salary expectations? * Were you referred to this job by a current employee at Azurity Pharmaceuticals? * Select... If you answered yes to being referred, please tell us who referred you! Will you now or in the future require sponsorship for employment? * Select... Are you willing to work on a hybrid schedule? (2 days working from home, 3 days in the office) * Select... How did you hear about us? * Select... Middle Name (if applicable) Street Address * Street Address Line 1 City * State * Select... Country * Select... 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 a confidential file. As set forth in Azurity Pharmaceuticals - US’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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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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Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com. Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity\'s success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization. Responsibilities
Maintain a robust and inspection-ready Quality Management System (QMS). Oversee the validation, integrity, and ongoing compliance of electronic quality systems. Ensure procedures are appropriately authored, reviewed, approved, and updated. Manage the Documentation Management System and ensure all controlled documents meet regulatory standards. Maintain compliant training records and quality documentation in alignment with regulatory expectations. Lead the development and implementation of a GxP training program for relevant personnel. Support the development and tracking of quality metrics and key performance indicators (KPIs). Provide governance and facilitate Quality Risk Management processes, including timely escalation to senior leadership. Lead continuous improvement initiatives for quality systems and processes. Oversee Change Control processes to ensure systematic and compliant change implementation. Manage the Product Quality Review (PQR) and Product Complaint programs, including investigations and Corrective and Preventive Actions (CAPAs). Oversee the Computer System Validation (CSV) program ensuring compliance with 21 CFR Part 11 and EU Annex 11. Serve as a primary quality compliance liaison with cross-functional departments, including Medical Affairs, Regulatory Affairs, and IT. Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field. Minimum of 10 years of experience in quality assurance, with at least 5 years in a leadership role within a GxP-regulated environment. In-depth knowledge of global regulatory standards (FDA, EMA, ICH, etc.) for quality systems. Strong expertise in risk management, product complaints, change control, and CSV. Proven ability to communicate complex compliance topics clearly to stakeholders at all levels. Excellent leadership, project management, and problem-solving skills. Physical & Mental Requirements
Must be able to sit for long periods of time While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear May occasionally climb stairs and/or ride elevators The employee must occasionally lift and/or move up to 25 pounds Employee must be able to manipulate keyboard, operate a telephone and hand-held devices Other miscellaneous job duties as required Benefits We Offer
Unlock Your Earning Potential: Join our team and be rewarded with a competitive compensation package, including an annual bonus based on company performance, that recognizes your exceptional talent. Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan. Fuel Your Success: Sales Only - We understand the value of your hard work and provide a car reimbursement program and gas card for both business and personal use as part of our commitment to supporting you. Comprehensive Health Coverage: We value your well-being and offer excellent medical, dental, vision, and prescription coverage to ensure you and your family are always taken care of. Flexibility for Your Lifestyle: Achieve work-life balance with our hybrid work model, allowing you to work two days from home and three days in the office. Excludes Sales, Manufacturing, and some Operations positions. Invest in Your Future: Our Retirement Savings Plan (401K) is designed to help you secure a comfortable retirement by matching dollar for dollar up to 5%. Time Off That Counts: Take advantage of our generous time off policy, which offers up to 15 vacation days annually + rollover (up to 40 hours) as well as five sick/wellness days. For new employees, vacation accrual will be prorated based on your start date. Meaningful Time with Your Loved Ones: We close between Christmas and New Year’s to give you an extra week off to spend quality time with your family and recharge. Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays. Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications. Recognize and Be Recognized: Our Azurity High Five peer recognition platform allows you to celebrate your colleagues' accomplishments and receive recognition for your own outstanding work. The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click here. The General Data Protection Regulation (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU). Apply for this job
indicates a required field First Name * Last Name * Email * Phone * Resume/CV * Enter manually Accepted file types: pdf, doc, docx, txt, rtf Enter manually Accepted file types: pdf, doc, docx, txt, rtf Education School * Select... Degree * Select... Select... Select... Start date year End date year LinkedIn Profile Website Prior to employment, you must consent to a background check and drug screen. Please acknowledge this requirement. * Select... What are your salary expectations? * Were you referred to this job by a current employee at Azurity Pharmaceuticals? * Select... If you answered yes to being referred, please tell us who referred you! Will you now or in the future require sponsorship for employment? * Select... Are you willing to work on a hybrid schedule? (2 days working from home, 3 days in the office) * Select... How did you hear about us? * Select... Middle Name (if applicable) Street Address * Street Address Line 1 City * State * Select... Country * Select... 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 a confidential file. As set forth in Azurity Pharmaceuticals - US’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 measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is 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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