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Quality Control Project Manager
Bachem
Vista, USA
Manager · 5+ years experience
USD 98408-135311 / year
Discovered 1 weeks ago
Free
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What you will do
- Manage customer projects and serve as the primary Quality Control point of contact for project-related activities, ensuring timely execution, cross-functional coordination, and compliance with GMP and regulatory requirements.
- Oversee critical testing activities at the Vista site, including stability studies and other regulatory-driven testing requirements.
- Support departmental leadership in project prioritization, resource planning, and allocation to ensure efficient execution of QC activities and project deliverables.
- Coordinate testing activities between Bachem sites to support timely product and service delivery while contributing to achievement of weekly operational and financial targets.
- Lead cross-functional resolution of testing issues at contract sites, including deviations and laboratory investigations, ensuring timely escalation, risk assessment, and effective resolution in alignment with quality and regulatory expectations.
- Lead customer communications with RA, QA, Project Management, and other stakeholders on stability issues, data trends, specification setting, and regulatory inquiries, ensuring clear escalation, alignment, and timely resolution of quality-related matters.
- Lead the authoring, review, and approval of project-related protocols, reports, and associated technical documentation, ensuring scientific accuracy, regulatory compliance, and alignment with GMP requirements.
- Lead and actively contribute to continuous improvement initiatives within the QC laboratory, including development and monitoring of KPIs to drive operational efficiency, compliance, and performance excellence.
Qualifications
- Bachelor's degree in chemistry or a related life sciences field
- 5+ years' QC experience in biotech/pharma
- 3+ years’ experience in a biotech/pharma CDMO setting
- 4+ years of project management experience in a GMP environment (preferred)
- Extensive experience with the use of analytical techniques/ instruments, including Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Karl Fischer (KF), etc.
- Excellent presentation skills
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