D06 - Qlty Assurance Methods​/Qa Methods Mgmt - Quality Manager

Quality Manager

Provides Quality support to External Manufacturing Operations (EXM) within a cross functional team and Product Disposition reviews for drug products manufactured/packaged by CMOs. Primary responsibility is to support Senior Manager or Associate Directors with management of CMOs, documentation related to product disposition, compliance with all Client Co. (Client) and applicable Food and Drug Administration (FDA) and international regulatory standards. In addition, to ensure that products released from CMOs comply with Client internal and government (FDA or specific market) requirements and support Quality Services processes (e.g. change controls, complaints).

Responsibilities:

• Support Senior Manager or Director Quality Operations with management of CMOs from a quality and compliance perspective, including: a. Monitoring quality metrics b. Performing annual risk assessment of CMOs and execute as needed c. Executing Risk Mitigation plans at CMOs as needed
• Compiles disposition documentation needed for release of products from CMOs
• Maintains files for all lots of materials released by Quality Operations, External Manufacturing
• Determines disposition of drug products according to Client and regulatory specifications and standards and escalates potential issues
• Authors Certificates of Analysis, Certificates of Conformance, Release Notifications and other release documentation as required by our customers or regional partners
• Input all required information into applicable enterprise-wide systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA)) related to external manufactured/packaged products - lot disposition, change controls, Corrective Actions and/or Preventive Actions (CAPAs) and deviations
• Assists Quality Operations team with review of change proposals, Quality Agreements, Annual Product Quality Reviews, and validation documentation as needed
• Participate in investigations, risk assessments related to manufacturing, packaging and testing issues as needed
• Participate during FDA/other regulatory inspections and corporate Good Manufacturing Practice (GMP) compliance audits as needed
• Follow up with CMO on audit observation responses
• Review / Approve, as required, Product Quality Complaints
• Write, review and implement SOPs to ensure compliance with current Client standard and current Good Manufacturing Practices (cGMPs)

Qualifications:

• B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
• A minimum of 8 years' experience in pharmaceutical, biologics, biotech or related industry with relevant experience
• Experience in a Quality Assurance, Quality Control or equivalent function is required
• Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
• Knowledge in solid dosage forms, parenteral technology, biologics or combination products
• Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them
• Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA))
• Good verbal and written communication skills essential
• Excellent interpersonal skills
• Capable to manage multiple priorities
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met