QA Director

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP
  3. United States
Parsippany-Troy Hills, New Jersey
Posting date: 27 Jun 2019
QA.YC.24106_1561664155

ProClinical is currently seeking a Director of Quality Assurance for a pharmaceutical company located in Parsippany, NJ. Successful candidate will be responsible for ensuring the quality of commercial products developed or sold by the Company and for ensuring that the client maintains all required systems and procedures required under applicable GxP regulations.

Job Responsibilities

  • Ensuring and overseeing supplier quality for all Company contactors and vendors.
  • Serving as the QA releasing authority for the Company's commercial products.
  • Representing the Company in regulatory authority meetings, as well as meetings with clients, partners, collaborators and consultants.
  • Overseeing all internal SOPs and ensuring that they are implemented and maintained as needed.
  • Providing annual GMP training for the Company and managing the employee training program.
  • Serving as a QA resource to contractors and vendors as needed.
  • Managing field alert reporting and recalling requirements for the Company, and coordinating directly with regulatory bodies, contractors and vendors as needed.
  • Serving as the lead in adherence to the DSCSA requirements including set up and maintenance of all connections.
  • Managing pharmacovigilance activities and handling all product quality complaints and inquiries.
  • Assisting in the selection process of new contract manufacturers and packagers through site visits and site quality history evaluation.

Skills and Requirements

  • BS/BA 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%.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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