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Manufacturing Site Quality Director
3 weeks ago
This role is responsible for leading the Quality function at a manufacturing site. The ideal candidate will have ownership of Quality Systems and Laboratory Control Systems, ensuring compliance with international standards and regulations.
The successful candidate will drive inspection readiness by overseeing the planning, implementation, and control of site Quality Systems and providing QA oversight for plant capital projects. They will collaborate closely with site leadership and global functions to ensure compliant and timely projects.
Key Objectives:
- Assess product introductions and major capital projects for quality and validation considerations.
- Collaborate with site and global functions to ensure compliant and timely projects.
- Establish and maintain an effective Quality organization managing Quality Systems, Method Validation, Analytical Testing, Registration, and Batch Release.
- Lead the development of compliant, robust, and lean Quality Management Systems aligned with regulatory requirements.
The successful candidate will have strong leadership and communication skills, as well as experience in pharmaceutical or veterinary manufacturing environments. They will be familiar with GMP regulations and expectations governing facilities, equipment, and procedures for the manufacture and control of APIs.
Requirements:
- Undergraduate degree in pharmaceutical, biological, or chemical sciences.
- Relevant advanced degree preferred.
- 10 years' experience in a pharmaceutical or veterinary manufacturing environment.
- Comprehensive knowledge of worldwide GMP regulations and expectations.
- Proven track record of making quality and compliance decisions.
As a Quality and Compliance Leader, you will be part of a dynamic team that fosters a culture of partnership and inclusion across departments. You will have opportunities to develop and implement Quality Systems and Standards at manufacturing site level, aligned with international standards and regulations.
Benefits:
- Competitive salary and bonus structure.
- 25.5 days holiday per annum plus public holidays.
- Defined contributory pension plan.
- Private medical insurance for you and your family.
To apply for this role, please visit our careers page and complete the application process.
