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Quality Assurance Director

  • LocationNew Haven, CT 06510 - United States
  • Work TypeFull Time - Permanent
  • Positions1 Position
  • Published At:5 days ago

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  • Job no: 37551
  • Categories: Quality

Job Description


Our client, a leading biopharmaceutical company, is currently recruiting a Quality Assurance Director who will infuse the Quality Assurance Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:


1) Plan and lead GCP audits, including clinical investigator sites, contract clinical laboratories and CROs to determine compliance status and identify compliance risks

2) Assess GCP compliance risk areas and develop and implement risk mitigation measures

3) Ensure compliance with company’s procedures and regulatory requirements

4) Conduct QA reviews of project-related Clinical Development essential documents and amendments

5) Review and provide input in to non-clinical documentation

6) Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies

7) Provide guidance, interpretation and information on GCP regulations, standards and quality systems

8) Develop and implement standards, policies and procedures for GCP regulatory compliance

9) Develop and measure quality metrics to drive consistent quality standards relating to GCP activities

10) Perform other duties as assigned


Critical Requirements


1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the biopharmaceutical industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality assurance management


For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.


Compensation and Other Details


Base Salary: Highly competitive package, commensurate with experience

  • Published on 04 May 2021, 1:17 PM