Vacancy Details

My client, a biopharmaceutical development and manufacturing company are looking for a Senior Quality Manager to join their growing team. This will give you the opportunity to join a company who are in a scale-up phase and work with stem-cell technology for their innovative product. You will have the chance to work closely with the Head of Quality for the company and work on a site with product development and manufacturing capacity, which you will have full quality oversight of.

Senior QA Manager

Location: Zurich

Salary: Competitive

Duration: Permanent

Job function:

• Ensure compliance to codes, standards, regulations, equipment specific specifications, and QMS requirements, including creation/revision of appropriate SOPs
• Manage, prepare and maintain key QA compliance systems (Deviations, CAPAs, Change Control, Risk analysis, Audits)
• Overview, Write and / or review deviations, change controls, CAPAs, complaints, risk assessments
• Prepare metrics and measures to drive assessment and continuous improvement – Develop compliance processes to reduce lead times
• Contribute to regulatory health authority inspections
• Manage the development and implementation of the QMS for planning, fabrication, inspection, documentation, and operations activities including:
  • Planning duties within the QA staff and related work schedules.
  • Establishing service standards for end users (i.e., internal department or external customer)
  • Providing leadership, mentorship, and direction to QA personnel

To be considered you need to have.

• M.Sc./PhD in a biological field (e.g. biology, tissue engineering, biotechnologies, and biomedicine) or a comparable education.

• Minimum of 5+ years working experience in regulated industry, pharmaceutical industry preferred.
• Ability to develop and manage non-conformance, deficiencies, including root cause analysis and risk analysis.
• Experience in developing and monitoring of QA project and QMS.
• Fluent English, German or French is a plus.

We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.