Quality Recruiting. Established Experts.

Director Quality Assurance

Reference Number: 3162
Location: MA

Our client is a leading pharmaceutical company.  They have asked us to assist them in their search for a Director Quality Assurance.

Major tasks and responsibilities will include:

  • Develops and maintains Quality Management System including the company quality manual, quality policies, and standard operating procedures (SOPs).
  • Manages the document control system and activities necessary to maintain company product documentation.
  • Writes, reviews, approves, and maintains Standard Operation Procedures for corporate requirements and cGxP documentation for CMC, clinical and preclinical functions.
  • Maintains QA and cGxP compliance for all aspects of the program to support clinical studies.
  • Oversees execution of Quality Systems such as Change Control, complaint investigations and deviation trending.
  • Leads in cGxP inspections of contract manufacturing and contract testing laboratories and monitor to ensure cGMP/GLP compliance.
  • Develops, negotiates and maintains Quality Agreements with external contractors and ensure requirements are met and enforced.
  • Interacts with in-house personnel and contract manufacturing and test facilities to coordinate and monitor quality aspects of production and testing activities.
  • Conducts and coordinates batch record review and perform lot disposition activities to ensure release of lots within prescribed timelines and in compliance with applicable regulatory submissions and approvals.
  • Supports equipment, utility and facility qualification activities.
  • Approves analytical method validations strategy and protocols and reports.
  • Approves process and product validation strategy and protocols and reports.
  • Participates in the preparation and review of CMC sections of regulatory submissions.
  • Performs and coordinates internal and external audits.
  • Coordinates risk management efforts.
  • Works with all functional area directors to insure that a uniform approach to Quality is established and maintained across the company.
  • Assists in the development and maintenance of the company’s training program.

We seek candidates with the following qualifications:

  • This person must have a minimum of a BS degree in a relevant scientific discipline.
  • Must have a minimum of 10 years of experience in QA management in biologic products, with vaccine experience is desirable.
  • Experience in reviewing cGMP/GLP related documents.
  • Has knowledge of cGMP principles with respect to FDA and EMA regulations.
  • Knowledge of cGCPs is a plus.
  • Experience working with contract manufacturing and testing facilities; experience with interacting with Qualified Persons.
  • Has experience with quality oversight and auditing of external vendors in the GMP environment.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3162. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.