About the Role: Leadership
- 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.
Contact: jgearhart@judge.com
