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Director of Quality Assurance

  • LocationBloomsbury, NJ 08804 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:10 days ago
  • Job no: 38229
  • Category: Quality

Job Description

Our client, a leading pharmaceutical company, is currently recruiting a Director of Quality Assurance 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) Supervise QA and QS managers by providing learning and development, where appropriate

2) Make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on sterility assurance during manufacturing operations

3) Manage the on-time release of batches

4) Manage the on-time initiation and closure of deviations and investigations, CAPAs, change controls with thorough and standardized supporting documentation

5) Manage others to ensure the appropriate SOPs and training documents are in place and effective

6) Manage others to ensure the design and maintenance of the environmental monitoring program, including environmental and personnel monitoring are adequate and in place

7) Manage others to ensure the company's quality standards are met at the site so that processes are the same as other company's sites

8) Maintain compliance with cGMP guidelines, state and federal laws

9) Prepare and submit weekly and monthly reports and prepare metrics and trends data to identify and prioritize continuous improvement opportunities

10) Manage others to maintain site documents supporting the commercial manufacturing and release of sterile injectable products

11) Manage the design and implementation of site policies and procedures

12) Escalate to the VP of Quality critical issues jeopardizing manufacturing and release of a safe and effective product that meet regulatory requirements

13) Communicate with the Operations Team regarding complaints, product issues and variances

14) Enforce the applicable personnel policies and procedures

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 pharmaceutical 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 19 Jul 2021, 12:43 PM