Manager, Product Quality Complaints - Azurity Pharmaceuticals - US
Woburn, MA
About the Job
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.
The Manager, Product Quality Complaints has the responsibility for implementing and maintaining the Product Quality Complaint Process for Azurity Pharmaceuticals, Inc. This position will report to the Associate Director, Quality Operations. This position handles complaint investigations which includes investigations at Azurity and CDMOs, coordination with medical affairs, trending complaints, escalation to FDA. Person also needs to handle FARs and product recalls.
Key Responsibilities:
- Propose, implement, and maintain the SOPs related to complaints, FARs and recall process.
- Ensure timely review and closure of Quality Product Complaint records in accordance with established procedures.
- Collaborates with cross-functional teams to ensure alignment and integration of quality objectives and activities on complaint handling process.
- Coordinate with internal and external organizations in complaint/recall handling process.
- Manage weekly complaint trending process.
- Provide monthly quality metrics to identify opportunities for improvement and mitigate compliance risks.
- Prepare customer response letters for complaints.
- Analyze Product Complaints and identify and escalate potential adverse trends.
- Support Annual Product Review and Production investigations.
- Support Audits and Inspections as the Subject Matter Expert (SME) for the Complaint Management System
- Works under minimal direction
- Anticipates and prevents potential issues with regulators.
- Raises potential Quality issues to Management.
- Maintains compliance with local and global processes.
- Handle health authority inspections.
Requirements:
- BS degree in Science in related field.
- Minimum of 8 years' experience in the Pharmaceutical/Biopharmaceutical Industry.
- Minimum three (3) years in a supervisory role.
- Three years (3) Experience with Quality Systems and GMP Regulations, specifically complaint investigations.
- Experience with investigation techniques, root cause analysis and risk assessment processes.
- Experience with report writing.
- Effective communication skills written and verbal.
#LI-Hybrid
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.
- 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*
- Start Your Week on a High Note: Indulge in our "Bagel Tuesday" perk, where you can enjoy a fresh bagel on us every Tuesday morning. **Only for On-site/Hybrid colleagues**
- 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 PTO policy, which offers 20 days annually + rollover (up to 40 hours).
- 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.
- Summer Vibes: Embrace the summer season with our Summer-Hours perk, available between Memorial Day and Labor Day. **Excludes Sales Colleagues**
- 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.
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