Senior QA Manager
- Recruit, develop and lead the QA team in areas of expertise and high performance team behaviours
- Provide technical expertise and leadership to the QA group with regard quality systems, document control and lot release
- During development and start up phases of the facility, plan for and lead, in collaboration with project and support functions, the set up facility and quality systems and procedures
- Drive implementation of a science and risk based Quality Culture throughout the facility
- Lead the preparation and facilitation of Regulatory Inspections
- Oversee activities relation to core quality systems including Deviations, Change Control and CAPA Systems
- Oversee relevant metrics for each quality system
- Participate in the Operations daily management meeting and coordinate all related activities including meeting minutes, distribution list, agenda topics, action items, correspondence, scheduling, etc.
- 8+ years experience in a cGMP regulated manufacturing environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- QP qualification would be an advantage.
- 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 expectations.
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