Quality Assurance Manager
The Judge Group Inc.

Cranbury, New Jersey

Posted in IT

Job Info

Location: Cranbury, NJ
Description: Our client is currently seeking a Quality Assurance Manager

This job will have the following responsibilities:

1. The Quality Assurance Manager will manage the development, implementation and maintenance of quality assurance systems and activities;

2. This individual will work collaboratively with our partners at our Contract Manufacturing Organizations (CMOs) and regularly lead meetings to discuss issues and seek continuous improvement across systems;

3. The individual will review contractor batch records, assess, and resolve quality issues, assist in final disposition of clinical and commercial products, and perform data and documentation reviews and analyses to assure finished products conform to government, company standards, and satisfy GMP and FDA regulations;

4. Develops and revises SOPs and oversees the generation and review of documents including internal and contract manufacturer documentation to ensure GxP compliance;

5. Develops and maintains audit programs, performs audits of contract manufacturers and vendors, prepares reports of audit findings and initiates, and monitors and enforces corrective action necessary to assure conformity to quality specifications;

6. Keeps abreast of regulatory procedures and ensures the development and implementation of SOPs to maintain compliance;

7. Participates in the preparation of document packages (IND, NDA, CTA) and responses to regulatory agencies;

8. Have working experience using electronic Quality Data Management Systems;

9. Team oriented and able to manage multiple projects across various development stages;

10. Excellent oral and written communication skills;

11. Accountable for ensuring adherence to strict regulatory requirements to ensure product quality;

12. Assists and ensures the effective transfer of analytical methods to CDMOs to support pre-clinical and clinical activities;

13. Ensures that quality-related complaints are investigated and resolved;

14. Manages Client's internal training program;

15. Small-mid size company and/or start-up experience preferred

Qualifications & Requirements:

Bachelor's Degree (preferably in a scientific discipline)

• 8-10+ years of hands-on experience in the pharmaceutical or biotechnology industry, with specific experience in GMP and Clinical Quality Assurance, CMO oversight, auditing, and Quality Systems

• Sound working knowledge of regulatory requirements (e.g., FDA/ICH, GCP, GMP Regulations) and experience with submissions (IND, NDA) and regulatory responses

• Experience with clinical and commercial batch disposition and review of analytical-related documents is strongly preferred

• Excellent verbal, written, interpersonal, organizational, and communication skills • Proficiency in MS Office Suite (Word, Excel, Power Point), Outlook

Contact: ktandukar@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com

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