Job Description
The Senior Manager is responsible for overseeing activities on-site related to the manufacture, release and distribution of IMPs and commercial products. This includes ensuring compliance with regulatory requirements and providing quality support to manufacturing operations.
Key Responsibilities:
* Serving as a designee for the Associate Director, QA in their absence, providing comprehensive QA and Compliance support to various departments.
* Coaching and mentoring colleagues to promote knowledge sharing and improve quality standards.
* Reviewing batch manufacturing documentation and ensuring timely review and approval of investigations and reports.
* Providing leadership for all people and culture initiatives within the QA team.
* Supporting broader site Quality Management activities, including contributing to Quality and Compliance objective setting.
Requirements:
* A minimum of 10 years of relevant experience within the Pharmaceuticals industry or a related field.
* Strong knowledge of cGMP requirements for pharmaceutical manufacturing.
* Direct experience in GMP management within a pharmaceutical /biopharmaceutical company is essential.
* Excellent accuracy and attention to detail.
* Good knowledge of relevant computer packages.
* Planning and organising skills are required to plan, execute and track commitments of Quality Assurance.
* High-level technical skills including analytical, auditing, biopharmaceutical manufacturing and regulatory inspection management.
* Excellent interpersonal skills and ability to communicate well.