New · posted Oct 15
Repligen · Biotechnology
Senior Manager, Quality
- Marlborough, MA
- On-site
- Full-time
- Manager
Open until filled
The role
The Senior Manager, Quality is a leadership role focused on strengthening quality systems, driving continuous improvement, and supporting a culture of quality across the Marlborough site. Working across functions and partnering with global quality teams, this role will lead key quality programs, use metrics to identify opportunities for improvement, and help advance initiatives that enhance compliance, efficiency, and the overall employee and customer experience.
What you need
- Bachelor's degree in Chemistry, Biology, Engineering, or a related scientific discipline.
- Minimum of 10 years of experience within an ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
- Minimum of 4 years of people leadership experience, including coaching, mentoring, and developing direct reports.
- Demonstrated expertise in Quality Management Systems, auditing, CAPA, document control, validation, and nonconforming material processes.
- Strong knowledge of Good Documentation Practices (GDP), root cause analysis methodologies, and quality investigation processes.
- Experience developing, tracking, and reporting quality metrics to drive performance and continuous improvement.
- Proven ability to lead cross-functional initiatives and influence stakeholders at multiple levels of the organization.
- Strong organizational, problem-solving, and project management skills, with the ability to balance strategic priorities and day-to-day execution.
- Experience leading quality system improvements, transformation initiatives, or digitalization projects preferred.
- Lean, continuous improvement, or operational excellence experience preferred.
- Excellent communication, collaboration, and relationship-building skills.
- Demonstrated commitment to fostering a positive quality culture and developing high-performing teams.
Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated base salary range for this role, based in the United States of America is $135,000-$190,000. Compensation decisions are dependent on several factors including, but not limited to an individual's ,qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.
This role is expected to model our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage, Team Empowerment, and Accountability & Results—in all aspects of work.
Skills named in this posting
What you'll do
- Maintain compliance with ISO 9001 and applicable quality requirements across all aspects of the Quality Management System, including internal and external audits, CAPA, nonconforming material management, validation activities, and document control.
- Lead, mentor, and develop direct reports, fostering a high-performing team culture built on accountability, collaboration, and continuous learning.
- Drive quality excellence initiatives that strengthen quality culture, improve organizational effectiveness, and support long-term business objectives.
- Partner with site leadership and global quality stakeholders to support the continued development and implementation of enterprise-wide quality management processes.
- Develop, monitor, analyze, and communicate quality metrics and KPIs to assess organizational quality health, identify trends, and drive data-based decision making.
- Lead or support internal and external audit programs, ensuring timely execution, effective root cause analysis, and completion of corrective and preventive actions.
- Oversee document control processes and ensure quality procedures, policies, and records remain compliant, effective, and current.
- Provide quality oversight for investigations, deviations, nonconforming materials, out-of-specification results, and CAPA activities, ensuring appropriate risk assessment and resolution.
- Identify and implement continuous improvement opportunities that increase efficiency, strengthen compliance, and enhance overall quality system effectiveness.
- Champion strategic quality projects, including digital transformation initiatives such as the transition from paper-based quality documentation and certificates to electronic quality systems.
- Collaborate effectively with cross-functional teams to support product release activities, operational priorities, and broader business initiatives.
- Utilize risk-based decision making to maintain compliance while enabling business success.
Pay and benefits
$135,000 – $190,000 a year
Employer providedPaid time off
Health/dental/vision
Retirement benefits
Flexible spending accounts
Variable cash programs (bonus or commission)
Equity eligibility
Where you'll work
Marlborough, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Marlborough, MAJob intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in Massachusetts18 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $135,000 | — | $190,000 |
| Massachusetts (middle half) | $116,500 | $133,250 | $153,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: Repligen's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Repligen's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk11
- Collaboration and leadership11
- GMP and compliance8
- Documentation and SOPs8
- Investigations and CAPA5
- Validation and qualification2
- Lab testing and methods1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
Repligen on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 4
- Locations
By discipline
- Quality4 80%
- Compliance & Safety1 20%
By level
- Senior & Principal3 60%
- Manager1 20%
- Associate & Specialist1 20%
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Senior Manager, Quality at Repligen
Open until filled. $135K–$190K a year, employer provided.