Senior Manager, Quality Systems at Azurity Pharmaceuticals

Woburn, MAFull-timeGlobal QualityPosted 30 days ago

About the Role

<div class="content-intro">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 <a href="http://www.azurity.com/">www.azurity.com</a>. 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.</div>  Brief team/department description: Job Type: Full-Time The Manager, Documentation Management plays a leadership role in sustaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position is responsible for ensuring the integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, with a strong focus on adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11. Principle Responsibilities: <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead the development, implementation, and continuous improvement of a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal standards.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Oversee the validation, integrity, and lifecycle compliance of electronic quality systems, including enterprise-wide document management platforms.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage the Documentation Management System, ensuring efficient control, authorship, review, approval, and periodic revision of all controlled documents (e.g., SOPs, policies, work instructions) in alignment with lifecycle and regulatory requirements.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Direct document lifecycle activities, ensuring timely execution and alignment with GxP standards and applicable regulatory frameworks.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Develop and lead GxP training strategies and programs to ensure that functional teams maintain a high level of quality awareness and compliance readiness.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Drive cross-functional continuous improvement initiatives aimed at optimizing quality system performance and documentation processes.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead the planning, oversight, and execution of the Computer System Validation (CSV) program to ensure compliance with 21 CFR Part 11, EU Annex 11, and internal validation requirements.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Serve as a point of contact for internal and external audits and regulatory inspections, ensuring documentation systems are readily accessible, compliant, and defensible.</li> </ul> Qualifications and Education Requirements: <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related field (advanced degree preferred).</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">5–7 years of progressive experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong working knowledge of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulatory standards.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proven experience managing electronic Document Management Systems and executing Computer System Validation (CSV) activities.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Demonstrated leadership, project management, and cross-functional collaboration skills.</li> <li style="font-family: arial, helvetica, sans-serif;">Exceptional attention to detail, organizational capability, and ability to manage multiple priorities in a fast-paced, regulated environment.</li> </ul> #LI-Hybrid  <div class="content-conclusion">Physical & Mental Requirements: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. <ul type="disc"> <li>Must be able to sit for long periods of time</li> <li>While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear</li> <li>May occasionally climb stairs and/or ride elevators</li> <li>The employee must occasionally lift and/or move up to 25 pounds</li> <li>Employee must be able to manipulate keyboard, operate a telephone and hand-held devices</li> <li>Other miscellaneous job duties as required</li> </ul> Benefits We Offer: <ul> <li>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. <ul> <li>Sales - In lieu of annual bonuses, we offer an Incentive compensation program that allows you to earn more - even over plan.</li> <li>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. </li> </ul> </li> <li>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.</li> <li>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*</li> <li>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%.</li> <li>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.</li> <li>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.</li> <li>Enjoy the Holidays: Over the course of the year, Azurity recognizes 13 holidays.</li> <li>Invest in Your Education: We support your professional growth with tuition reimbursement for undergraduate and graduate level courses or certifications.</li> <li>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.</li> </ul>   The California Consumer Privacy Act regulates privacy rights and consumer protection for residents of California, United States. For details, click <a href="https://azurity.com/privacy-policy/" target="_blank">here.</a> The <a href="https://gdpr.eu/" target="_blank">General Data Protection Regulation</a> (GDPR) sets guidelines for the collection and processing of personal information from individuals who live in the European Union (EU).  </div>

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