Lead and supervise a team of Quality Managers overseeing third-party manufacturers and partners responsible for injectable/combination products.
Responsibilities: Third-Party Support
Ensure that all injectable/combination products are manufactured, packaged, and tested in compliance with cGMPs, approved ANDA/NDA, regulatory requirements, and company policies.
Manage the batch release process for third-party manufactured products.
Oversee Quality review and approval of vendor-generated batch documentation, including process validation protocols, analytical method validation, and batch records.
Ensure compliance with regulatory requirements for Annual Product Reviews, stability management, and sample management.
Maintain Quality Agreements with suppliers and support GMP audits of third-party suppliers.
Responsibilities: Compliance
Implement and uphold the company's Quality Management System (QMS).
Ensure third-party partners adhere to appropriate regulations and product requirements.
Oversee metrics reporting, Quality Management Review activities, and Performance Mapping for the Sterile/Combination product group.
Responsibilities: Interdepartmental Support
Collaborate with Supply Chain, R&D, and Product Launch teams to support the development and launch of products.
Act as the main Quality point of contact for Due Diligence during acquisitions of new products or facilities, demonstrating solid knowledge of cGXP and audit experience.
Qualifications:
Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biology, or related field. A minimum of 15 years in the pharmaceutical industry, with at least 10 years in an ISO 13485 certified organization and 5 years in a managerial role across Quality functions.
Extensive experience with injectable/combination products and expert knowledge of cGMPs, FDA, USP, ISO, and ICH guidelines.
Strong leadership skills in communication, collaboration, and decision-making.