Mgr, Pharmaceutical Development Quality Assurance (Remote/Home Based)

Jazz Pharmaceuticals; City Of London; Remote; GBP 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a Manager for Pharmaceutical Development Quality Assurance to ensure compliance with international standards and oversee quality assurance processes. This remote role involves collaborating with contract manufacturers and leading audits while supporting the development of Investigational Medicinal Products. The ideal candidate will have a strong background in pharmaceuticals and quality assurance, with a focus on continuous improvement and regulatory compliance. Join a dynamic team dedicated to transforming patients' lives through innovative medicines.

Benefits

Health Insurance

Retirement Plans

Paid Vacation

Qualifications

• Experience in pharmaceuticals, quality assurance, and manufacturing.
• Eligibility to act as a licensed Qualified Person preferred.

Responsibilities

• Monitor GMP operations to ensure compliance with cGMP standards.
• Lead third-party vendor audits for IMPs and quality issues.
• Develop and maintain Quality Systems for compliance.

Skills

Pharmaceutical Development

Quality Assurance

Analytical Chemistry

Regulatory Compliance

Vendor Audits

Education

Bachelor's degree in Chemistry

Bachelor's degree in Biology

Job description

Mgr, Pharmaceutical Development Quality Assurance (Remote/Home Based)

If you are a current Jazz employee, please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma company dedicated to transforming patients' lives through innovative medicines for serious diseases, including sleep disorders, epilepsy, and cancer. Headquartered in Dublin, Ireland, with R&D labs and manufacturing facilities worldwide, we focus on pioneering research and development in oncology and neuroscience. For more information, visit www.jazzpharmaceuticals.com.

This position is part of the PDQA team within the Manufacturing Quality division. It supports Product Development (PD) manufacturing operations and the development of Investigational Medicinal Products (IMPs), ensuring the provision of suitable IMPs for clinical trials.

Essential Functions/Responsibilities

1. Represent PDQA on CMC matrix teams for Jazz development projects.
2. Monitor GMP operations at Contract Manufacturers/Packagers of IMPs to ensure compliance with international cGMP standards.
3. Perform batch reviews, product complaint reviews, change controls, and investigations (OOS, deviations, CAPAs).
4. Generate Product Specification Files or Technical Review Files.
5. Act as a Qualified Person (QP) on Jazz Manufacturing and Import Authorization (MIA) for IMPs to ensure clinical trial supply.
6. Collaborate with contract manufacturers, packagers, and testing labs to resolve quality issues.
7. Lead third-party vendor audits for IMPs, including GMP contract manufacturing, analytical testing, and storage facilities.
8. Oversee the product stability program for IMPs, including data review.
9. Develop and write SOPs and controlled documents.
10. Review and approve IMP product labeling.
11. Maintain relationships and participate in meetings with contract manufacturers, managing Quality Technical Agreements (QTAs).
12. Manage supplier qualification and discontinuation processes.
13. Participate in continuous improvement initiatives using Operational Excellence programs.
14. Develop and maintain Quality Systems to ensure compliance with international cGMP standards.
15. Support validation activities and CTSM with timely quality reviews to ensure clinical material supply.
16. Work with other departments to ensure compliance and effective collaboration.
17. Support regulatory submissions as needed.

Qualifications include experience in pharmaceuticals, analytical chemistry, quality assurance, quality control, development, or manufacturing. Experience with vendor audits, complaint handling, change control, and regulatory interfaces is required. A Bachelor's degree in chemistry, biology, or related fields is necessary, and eligibility to act as a licensed Qualified Person is preferred.

Jazz Pharmaceuticals is an equal opportunity employer. Benefits include health insurance, retirement plans, and paid vacation. More details are available at our benefits page.