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Biotechnology Quality Manager Position
2 weeks ago
The position of Quality Assurance Leader plays a pivotal role in ensuring the high quality and compliance of our partnered contract laboratories, commercial manufacturing organizations (CMOs), and raw material suppliers responsible entities (SREs). This involves coordinating with marketing applications, negotiating and approving quality agreements, and leading site preparations for regulatory inspections.
Responsibilities:
- Oversight of contract labs, CMOs, and SREs to maintain quality standards
- Negotiation and approval of quality agreements to ensure seamless partnerships
- Leading the preparation of sites for regulatory inspections to ensure smooth operations
- Presenting key information during inspections, showcasing expertise and appropriate behaviors
- Review and approval of Master Batch Records, deviations, change controls, and CAPA
- Preparing inspection playbooks and identifying/mitigating risks at CMOs or testing laboratories
- Performing Person in Plant activities as required, managing audit commitments, and performing tactical batch disposition activities to support lot release
- Making decisions on batch release/rejection, deviation/approval, change control/CAPA, and QAGR approval
Requirements:
- A doctorate degree and 2 years of relevant experience, OR a master's degree and 4 years of relevant experience, OR a bachelor's degree and 6 years of relevant experience, OR 10+ years of experience in the biotech/pharmaceutical industry
- Additional European languages are desirable but not essential
- Significant quality experience at aseptic manufacturing facilities is highly valued
- Ability to influence senior stakeholders and manage workloads effectively
- Strong project management, problem-solving, and analytical skills
- Demonstrated ability to lead cross-functional teams, deliver results on-time, and provide high-quality outcomes
Package Details:
This is a contract role offering an hourly rate between €60-€70. The minimum contract duration is 12 months, with expectations for remote work. Occasional onsite requirements may arise, primarily at our Dun Laoghaire location, though regular travel is not anticipated.
