Director, Quality Assurance at The Judge Group Inc. in Bedminster, New Jersey

Job Description:

Location: Green Knoll, NJ

Salary: TBD

Description: Our client is currently seeking a Director, Quality Assurance for a permanent direct hire position



Leadership:

• Lead and supervise a team of Quality Managers overseeing third-party manufacturers and partners responsible for injectable/combination products.

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.

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.

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


This job and many more are available through The Judge Group. Find us on the web at www.judge.com Apply Now