Senior Quality Leader: ISO 9001, Audits & QMS Improvement

Repligen Corp; Marlborough (MA); On-site; USD 135,000 - 190,000; Full time

Benefits offered by this job

Paid time off

Health/dental/vision benefits

Retirement benefits

Flexible spending accounts

Job summary

Repligen Corp is seeking a Senior Manager, Quality in Marlborough, MA to strengthen quality systems and drive continuous improvement across functions. You will lead quality programs, mentor teams, and partner with global quality stakeholders to implement enterprise-wide processes and data-driven decisions.

The role emphasizes governance of CAPA, audits, governance of documentation, and key metrics. A strong leadership track record and hands-on experience in ISO-regulated environments are

Qualifications

• Bachelor's degree in Chemistry, Biology, Engineering, or related field.
• Minimum of 10 years in ISO 9001, ISO 13485, cGMP, or comparable regulated quality environment.
• Minimum 4 years of people leadership experience with coaching and developing direct reports.
• Strong expertise in QMS, auditing, CAPA, document control, validation, and nonconforming materials processes.
• Knowledge of GDP, root cause analysis methodologies, and quality investigations.

Responsibilities

• Maintain ISO 9001 compliance and audits across the Quality Management System.
• Lead, mentor, and develop direct reports to build a high-performing team.
• Drive quality excellence initiatives to strengthen culture and operational effectiveness.
• Collaborate with site leadership and global quality stakeholders to advance enterprise-wide processes.
• Develop, monitor, and report quality metrics and KPIs to drive data-based decisions.
• Oversee audits, CAPA, investigations, deviations, and risk assessments as needed.
• Support digital transformation of quality documentation and electronic systems.
• Enable product release activities and cross-functional priorities with quality input.

Skills

Quality Management Systems

Auditing

CAPA

Document control

Validation

Nonconforming materials

GDP

Root cause analysis

Quality metrics

Cross-functional leadership

Lean / Continuous improvement

Digital transformation

Education

Bachelor's degree in Chemistry, Biology, Engineering, or related scientific discipline

Job description

Repligen Corp is seeking a Senior Manager, Quality in Marlborough, MA to strengthen quality systems and drive continuous improvement across functions. You will lead quality programs, mentor teams, and partner with global quality stakeholders to implement enterprise-wide processes and data-driven decisions.

The role emphasizes governance of CAPA, audits, governance of documentation, and key metrics. A strong leadership track record and hands-on experience in ISO-regulated environments are