Manager, Product Complaints at Azurity Pharmaceuticals

Woburn, MAFull-timeGlobal QualityPosted 24 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>About the Role If you're eager to be part of a dynamic, global, and fast-growing organization—where a positive mindset, personal development, and making a meaningful impact on people’s health are valued—we could be the perfect match. The Manager, Product Complaints at Azurity will play a crucial role in overseeing global end-to-end complaint intake, investigation, and trending to ensure timely, compliant resolution of product quality issues and drive continuous improvement across the product lifecycle to ensure compliance with regulatory requirements and internal quality standards. This role provides strategic direction in alignment with the Quality Management System (QMS).  Key Responsibilities <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage and approve Product Complaints throughout the entire product lifecycle, ensuring timely investigation and resolution.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support Field Alerts and Defect Notifications to Health Authorities globally (US, CAN, EU).</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Identify new capabilities, implementing/ delivering improvements.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Maintain and support inspection readiness.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Lead product complaint investigations, coordinating with CMOs for external investigations, performing Root Cause Analysis, identifying Corrective Actions, and escalating critical issues to senior management.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support SOP management.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Event/Quality Issue Management process and requirements, including CAPA and Effectiveness Check.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Project Management, Planning and Prioritization of Product Complaints.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Support and coordinate complaint trends, KPIs, and quality metrics to identify risks and drive continuous improvement initiatives.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Prepare management reports, dashboards, and quality trend presentations for senior leadership.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Collaborate cross-functionally with Quality Operations, Regulatory Affairs, Pharmacovigilance, Supply Chain, and Commercial teams to ensure effective complaint handling and risk mitigation.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Manage and prepare Risk Assessments for product complaints using both qualitative and quantitative approaches.</li> </ul> Required Skills and Experience <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Technical writing skills.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Adaptability / flexibility and ability to work in a fast-paced environment and act with urgency.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Strong analytical thinking skills, with the ability to translate data into risk-informed insights that drive decision-making.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Continuous-improvement mindset and strong stakeholder-management capability.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Knowledge of pharmaceutical product lifecycle management and quality processes.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Detail-oriented with strong organizational skills, capable of managing multiple tasks.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Experience with Veeva systems and proficiency in Excel.</li> </ul> Preferred Qualifications <ul> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Minimum of 8-10 years of experience in Quality Assurance within the pharmaceutical, biotechnology, or medical device industries BS, MSc, or PhD in a scientific discipline.</li> <li style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">Proven experience in inspections/audits.</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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