The Quality Control manager is responsible for leading the laboratory personnel responsible for testing and disposition of drug substance and drug product.
The position requires knowledge and experience with HPLC, electrophoresis, enzyme kinetics, spectrophotometry, or other similar analytical testing.
It is expected that the incumbent will lead in a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions.
- Lead the laboratory personnel responsible for testing and disposition of drug substance and drug product.
- Develop and lead the QC team in areas of expertise, use of operational excellence tools, and high performance team behaviours.
- Provide technical expertise and leadership to the QC group ensuring samples are tested under cGMP within specified timelines.
- Provide oversight of out-of-specification/out-of-trend result investigations and documentation of same.
- Interface with other departments (Regulatory Affairs, Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary.
- Maintain the laboratory in an inspection-ready state.
- Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives
- Participate in budget planning. Communicate capital equipment needs, facility needs, staffing needs; and contract service requirements.
- Identify and conduct personnel training for quality control personnel, prepare performance appraisals and recruit staff.
- M.Sc. with at least 8 years of experience in a relevant functional area, or a B.Sc. with at least 10 years experience in a relevant functional area (at least 2 years in Quality Control).
- 8+ years experience in a cGMP regulated Quality Control environment.
- Demonstrated expertise with analytical methods used to assess pharmaceuticals and biologics, especially HPLC and other analytical tools
- Organizational and management skills to coordinate multi-discipline project groups
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and recommendations for process validation expectations.
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