A brief overviewResponsible for leading and managing all Quality Control project activities, serving as the primary point of contact between QC teams, cross-functional departments, senior leadership, and external clients. Oversees project planning, execution, resource allocation, risk management, and timeline adherence to ensure successful project delivery. Ensures QC testing activities are completed in compliance with regulatory requirements, GMP standards, and company procedures while driving operational efficiency, strategic communication, and continuous improvement initiatives. Provides leadership and direction to project teams to support organizational objectives and client expectations.
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
- Ability to coordinate and maintain contracted vendor services and work assignments.
Base Annual Salary Range: $98,408 - $135,311Placement of new hires in this wage range is based on several factors including education, skill sets, experience, and training.
Total RewardsWe offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.
Corporate Social ResponsibilityBachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness. EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.
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