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Associate Director of Quality Assurance

Fort Lee, NJ, United States

Job Description

Our client, a leading pharmaceutical company, is currently recruiting an Associate 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) Review and approve quality system records, including change requests, deviations, and CAPA, as necessary

2) Review and approve validation and qualification of insulin biosimilars and escalation of issues to management

3) Provide manufacturing shop floor support to achieve smooth facility startup

4) Disposition of drug substance from external partners

5) Review and approve SOPs, quality risk assessments and quality plans related to manufacturing operations, as needed

6) Ensure manufacturing and QC adherence to company policies/procedures, regulatory licenses, industry standards, and GMP regulations

7) Work in cross-functional teams to achieve team goals

8) Influence across the organization to establish a culture of excellence and right-first-time execution.

9) Partner and influence other departments and functions throughout the organization

10) Comply with the company's policies and procedures

11) 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 pharmaceutical industry is strongly preferred

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

This is a wonderfully rewarding role for the right leader 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 Nov 2023, 9:31 AM

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