Senior Manager Job Description
The Senior Manager is responsible for ensuring oversight of activities on-site associated with the manufacture, release and distribution of IMPs and commercial products. This includes Quality Assurance (QA), Compliance, and Regulatory Affairs.
Key Responsibilities:
* Act as designee for the Associate Director, QA in their absence.
* Provide comprehensive QA and Compliance support to new product Introduction, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
* Coach and mentor colleagues to promote knowledge sharing and a culture of excellence.
* Review batch manufacturing documentation and ensure timely approval, highlighting and assisting in the resolution of issues commensurate with the level of risk.
* Collaborate with cross-functional teams to ensure readiness for Audits and Inspections in Quality/Operational areas through a program of readiness activities.
* Develop initiatives to improve quality standards via actively driving continuous improvement activities in the QA team.
* Provide leadership for people and culture initiatives within the QA team and throughout the site.
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 required.
* Direct experience in GMP management within a pharmaceutical /biopharmaceutical company is essential and will include exposure to regulatory authorities.
* Excellent accuracy and attention to detail.
* Good knowledge of relevant computer packages e.g. Trackwise, SAP, MES or similar.
* 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 are required, as is the ability to communicate well, both verbally and written.