Job Description
Manager Quality, External Supply
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:
- 10-12 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 (3) years of experience in overseeing quality operations for sterile and aseptically manufactured pharmaceutical products
Job Tags
Work experience placement