Sr. Manager Quality, External Supply

Job Description

Key Responsibilities

• Demonstrate strong knowledge of cGMPs, applicable GxPs, and pharmaceutical distribution processes.
• Perform routine quality audits of CMOs, including follow-up and timely closure of CAPA actions.
• Establish and maintain quality standards aligned with current regulatory requirements and PCC management expectations.
• Ensure implementation of the Quality Policy, Quality Management System (QMS), SOPs, and GMP regulations across External Supply and satellite Quality operations.
• Lead and/or support meetings with external manufacturing organizations to review manufacturing status, complaints, and non-conformances.
• Manage internal and external change controls, including impact assessments and approvals.
• Coordinate technically with cross-functional teams to expedite resolution of complaints, deviations, change controls, and investigations.
• Prepare, review, and maintain quality documentation, including Quality Agreements.
• Manage non-conformance and complaint investigations at external sites, including initiation and tracking within internal systems.
• Support changes to specifications, processes, or procedures at external sites, including initiation of internal tracking documents, assignment of action items, and project closure.
• Provide final product disposition, including review of externally generated batch records and analytical testing results.
• Manage stability programs for externally manufactured products, including review and evaluation of stability data.
• Review and/or approve Annual Product Quality Review (APQR) documents for externally manufactured products and support Regulatory Affairs with Annual Reports.
• Conduct internal audits and participate in regulatory audit preparation, including CAPA development and ensuring timely CAPA closure.
• Review and approve artwork and labeling, ensuring only current, approved versions are used.
• Lead supplier qualification and approval, including audit planning, execution, documentation, and tracking of audit findings to closure.
• Support CMOs and internal functions (Supply Chain, Technical Operations, Regulatory Affairs) in process validation, API qualification, and related activities.
• Support Business Development and Sales for product launches in new markets by ensuring timely quality deliverables and effective CMO communication.
• Represent Quality Assurance in CMO-related projects, including technology transfers, providing guidance on quality requirements and reviewing transfer protocols and reports.
• Support CMO Quality Operations activities, including SOP development, document management, training, and implementation.
• Contribute to new quality initiatives and support development of long-term quality strategy.

Requirements:

• 14-16 years working experience in a regulated Pharmaceutical Company in GMP environment
• Hands on experience of quality systems in a GxP environment, and direct experience with USFDA and other health authority inspections
• A minimum of (5) years of experience in overseeing quality operations for sterile and aseptically manufactured pharmaceutical products