Manager, North America Quality Operations

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.

 

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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