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Quality Assurance Manager

Job Description

Edenbridge Pharmaceuticals is seeking a Quality Assurance Manager to join the Company at its Parsippany, NJ corporate office. The position will be responsible for ensuring the quality of commercial products developed or sold by the Company and for ensuring that Edenbridge maintains all required systems and procedures required under applicable GxP regulations. This position will be a client and partner liaison and requires high-level technical expertise and excellent communication skills. The successful candidate will:

  • Ensure supplier quality for all Company contactors and vendors, including performance of on-site audits.
  • Serve as a QA release authority for the Company’s commercial products.
  • Participate in regulatory authority meetings, as well as meetings with clients, partners, collaborators, and consultants.
  • Oversee all internal SOPs and ensure that they are implemented and maintained as needed to be in compliance with all federal and state regulatory requirements.
  • Provide annual GMP training for the Company and manage the employee training program.
  • Serve as a QA resource to contractors and vendors as needed in the conduct of investigations into product quality events.
  • Assist in field alert reporting for the Company, and coordinate with contractors and vendors as needed to ensure thorough investigation of the potentially impacted product.
  • Serve as the lead in adherence to the DSCSA requirements including set up and maintenance of all connections.
  • Assist in pharmacovigilance activities and handling of product quality complaints and inquiries.

Qualifications

  • Bachelor’s degree with 5+ years work experience in US FDA regulated pharmaceutical development and manufacturing.
  • Self-starter who can be effective with minimal supervision.
  • Previous experience working in a virtual or small company environment strongly preferred.
  • Excellent communication and interpersonal skills across all levels of the Company.
  • Strong writing skills consistent with the ability to prepare concise, timely, and accurate reports.
  • Travel requirement of up to 10%.

Qualified candidates should submit their resumes directly to careers4@edenbridgepharma.com.