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Quality Assurance, Director

Job Description

Edenbridge Pharmaceuticals is seeking a Director of Quality Assurance 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, partner and regulatory authority liaison and requires high level technical expertise and excellent communication skills. This is an opportunity for an individual to join a growing specialty pharmaceutical company and work directly with the senior management of the Company. The successful candidate will:

  • Ensure and oversee supplier quality for all Company contactors and vendors, including performance of on-site audits and visits as needed.
  • Serve as the QA release authority for the Company's commercial products.
  • Represent the Company 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.
  • Manage field alert reporting and recall requirements for the Company, and coordinate directly with regulatory bodies, contractors and vendors as needed to ensure compliant handling of products under investigation.
  • Serve as the lead in adherence to the DSCSA requirements including set up and maintenance of all connections.
  • Manage pharmacovigilance activities and handle all product quality complaint and inquiries.
  • Assist in the selection process of new contract manufacturers and packagers through site visits and site quality history evaluation.

Qualifications

  • Bachelor's degree with 15+ years work experience in US FDA regulated pharmaceutical development and manufacturing.
  • Previous experience working in a virtual or small company environment.
  • Self-starter who can be effective with minimal supervision.
  • Strong leadership skills necessary to oversee all quality operations of the Company.
  • Excellent communication and interpersonal skills across all levels of the Company.
  • 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 careers6@edenbridgepharma.com