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.

Brief team/department description:

Azurity is seeking a Quality Assurance Manager to support US batch release activities and ensure full compliance with US GMP and GDP regulations. In addition, this role will support North American Quality Operations including CMO oversight, deviation assessment, change control, CAPA management, audits, and technical batch release.

Principle Responsibilities:

Provide QA oversight for all quality aspects of assigned vendors based in US/CAN, including deviation/OOS/OOT investigations and assessment, change control, CAPA evaluation and complaint approvals.
Establishment and maintenance of Quality Assurance Agreements with US Vendors.
Assess technical documentation for batch disposition (e.g., CoAs, investigation reports, stability data, transportation records) to support in-market product release.
Batch disposition for commercial and clinical batches in accordance with current US FDA GMP requirements (21 CFR Parts 210/211) and Marketing Authorization.
Ensure pharmaceutical Products are manufactured in accordance with current Good Manufacturing Practice (GMP) and specifications approved in Marketing Authorizations.
Ensure pharmaceutical Products are distributed in accordance with Good Distribution Practices (GDP).
Support regulatory inspections from FDA and manage follow-up actions.
Establishment and maintenance of a compliant US Quality Management System: deviation handling, CAPAs, change control, product quality reviews, stability programs, document control and risk assessments. Management of quality and compliance risks impacting US batches.
Conduct and support GMP/GDP audits of CMOs, 3PLs, and contract labs within the US.
Drive continuous improvement and ensure training of QA personnel related to US compliance requirements.
Management and disposition of returned Products from the US market
Management of Product recalls and involvement in periodic mock recalls for US market
Reporting of any Product defects to FDA • Ensure quality processes align with international standards (e.g. ICH, PIC/S) and local market requirements.
Collaborate cross-functionally with Supply Chain, Regulatory Affairs, Technical Operations, for the supply of medicinal products to the US market.

Qualifications and Education Requirements

Advanced degree in pharmacy, chemistry, biology, or other science-related field.
Minimum 10 years in pharmaceutical QA.
Previous experience with batch release is required.

#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 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.
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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Azurity Pharmaceuticals - US

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