Quality Control Manager ( Sr. Associate Director)
ROLE OVERVIEW
Directly and through subordinates and peers, the Quality Control Manager leads a multifunctional team comprised of Quality Control BioImmuno, Chemistry, Microbiology, and Quality Control Operation team reporting into the Vice President Global Quality Unit.
RESPONSIBILITIES:
- Responsible for People management, resource mapping and QC budget
- Responsible for the management of resources, budget and planning of Quality Control and Quality Operation team. Identify resource, budget needs and planning needs and escalate to leadership and project managers as appropriate.
- Responsible for RFP (Request For Proposal) and contract assessment and strategy
- Responsible for project strategy, implementation of regulatory feedback, objectives, specifications, deliverables, and timelines with respect to analytics.
- Member of Quality Leadership team and extended CMC leadership
- Member of Specification and Change Control Board
- Responsible for IND and IMPD review
- Responsible for analytical technology transfer from development department to Quality Control department to internal and external Quality Control department
- Responsible for the HSE and GMP compliance of the Quality Control department and the compliance of the projects as appropriate according the required local requirement, EMA, FDA and PICs guidelines.
- Responsible for supporting the matrix organization with support to projects by identify and track critical path/activities, risks, and manage contingency, alternative plans and ensure QC operations provide regular updates to the relevant CMC Project Lead.
- Responsible for report generation on KPIs, High/Low lights of the Quality Control team and report mitigation strategy to Head of Quality Unit.
- Responsible for attracting and maintaining talent and guard relevant knowledge management and documentation management.
EDUCATION AND DESIRED EXPERIENCE:
- PhD or equivalent immunology, biochemical engineering, biochemistry, biology, or related discipline
- At least 10 years of relevant biologics experience in an industrial setting under GMP standards with strong knowledge of FDA, EMA and Swissmedic guidelines; CDMO experience is a plus
- Relevant Process and QC experience and knowledge of current analytical techniques
- Excellent communication skills and strong diplomacy skills required
- Fluency in English, both written and verbal; French is a plus
- Proven ability to work with flexibility in a changing and demanding environment and working in a matrix environment.
- Ability to work independently with persuasiveness within team and cross-functional.
- Strong sense of discipline, exceptional organization skills, leadership excellence, excellent team orientation, people manager and client orientation.
LOCATION:
You will join us, in a picturesque city of La Chaux-de-Fonds, Neuchâtel, Switzerland.