Senior Manager, Quality
Repligen · Marlborough, MA
QualityFull-time$135k–$190kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Repligen seeks a Senior Manager, Quality to lead quality systems and continuous improvement initiatives at its Marlborough site. The role involves managing compliance, mentoring direct reports, driving quality excellence programs, and partnering with global teams to strengthen quality culture and organizational effectiveness.
What they're looking for
- Bachelor's degree in Chemistry, Biology, Engineering, or related scientific field
- Minimum 10 years experience in ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment
- Minimum 4 years people leadership experience including coaching and developing direct reports
- Demonstrated expertise in Quality Management Systems, auditing, CAPA, and validation processes
- Strong knowledge of Good Documentation Practices and root cause analysis methodologies
- Experience developing and reporting quality metrics and KPIs to drive improvement
- Proven ability to lead cross-functional initiatives and influence stakeholders across organizational levels
What you'll be doing
- Maintain ISO 9001 compliance across Quality Management System including audits, CAPA, and document control
- Lead, mentor, and develop direct reports to build high-performing, accountable team
- Drive quality excellence initiatives that strengthen culture and support business objectives
- Develop and monitor quality metrics and KPIs to assess performance and identify improvement opportunities
- Lead or support audit programs, investigations, and corrective action completion
Privacy & handoff
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