Manufacturing Quality Events Lead (CAPA & Change Controls)

Vertex Pharmaceuticals Inc (US)

Leiden

On-site

EUR 123,000 - 185,000

Full time

9 days ago
Application generator

Don’t send a generic resume — generate a resume and cover letter tailored to this exact role.

Get past ATS filters

Benefits offered by this job

Medical, dental and vision benefits
Generous paid time off
Commuting subsidy
401(k) matching

Job summary

Vertex Pharmaceuticals is seeking a Senior Manager, Manufacturing Technical Operations (MTO) to lead the quality-record strategy for quality events at our Boston site. You will oversee CAPAs, deviations, change controls, and analytical investigations, driving timely closure and data-driven improvements.

This on-site role requires 2nd shift and weekend availability to support manufacturing operations, with collaboration across Manufacturing, Quality Assurance and other functions to promote a

Qualifications

  • Bachelor’s degree in engineering, Life Sciences, or related technical discipline.
  • 6+ years in biopharmaceutical manufacturing, quality, manufacturing sciences, process engineering, or process development.
  • 2+ years mentoring, supervising, or managing staff.

Responsibilities

  • Lead quality-record execution including CAPAs, deviations, and analytical investigations.
  • Provide strategic oversight for CAPA and change-control records.
  • Lead cross-functional investigations to determine root cause and corrective actions.
  • Establish and promote MTO- and QA-aligned best practices for quality-event excellence.
  • Monitor quality-event performance and prioritize work using data-driven decisions.

Skills

Leadership
Quality events
CAPA management
Change controls
Analytical investigations
Root cause analysis
Project leadership
Communication
Data-driven decisions

Education

Engineering or Life Sciences degree

Job description

Vertex Pharmaceuticals is seeking a Senior Manager, Manufacturing Technical Operations (MTO) to lead the quality-record strategy for quality events at our Boston site. You will oversee CAPAs, deviations, change controls, and analytical investigations, driving timely closure and data-driven improvements.

This on-site role requires 2nd shift and weekend availability to support manufacturing operations, with collaboration across Manufacturing, Quality Assurance and other functions to promote a

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

GMP Operational Quality Lead - On-Site Associate Director
GMP Operational Quality Lead - On-Site Associate Director

Vertex Pharmaceuticals Inc (US) • Leiden

On-site
EUR 136,000 - 204,000
Senior Materials Management Lead — Onsite, 5 Days, Equity Eligible
Senior Materials Management Lead — Onsite, 5 Days, Equity Eligible

Vertex Pharmaceuticals Inc (US) • Leiden

On-site
EUR 109,000 - 164,000
Senior Manager, Manufacturing Technical Services
Senior Manager, Manufacturing Technical Services

Vertex Pharmaceuticals Inc (US) • Leiden

On-site
EUR 123,000 - 185,000
Medical, dental and vision benefits
Generous paid time off
Commuting subsidy
+1
Senior Process Engineering Leader
Senior Process Engineering Leader

Vertex Pharmaceuticals Inc (US) • Leiden

On-site
EUR 122,000 - 183,000
Annual bonus
Equity awards
On-site five days/week
Senior GxP Facilities Engineer Onsite, Impactful Compliance
Senior GxP Facilities Engineer Onsite, Impactful Compliance

Vertex Pharmaceuticals Inc (US) • Leiden

On-site
EUR 90,000 - 136,000
QA Operations Specialist – Onsite Shopfloor (CGMP)
QA Operations Specialist – Onsite Shopfloor (CGMP)

Bristol-Myers Squibb • Netherlands

On-site
EUR 45,000 - 65,000
Principal Process Engineer – Cell & Gene Therapy Automation
Principal Process Engineer – Cell & Gene Therapy Automation

Vertex Pharmaceuticals Inc (US) • Leiden

On-site
EUR 123,000 - 185,000
Senior Manager, GCP/GVP Quality Assurance
Senior Manager, GCP/GVP Quality Assurance

Qabird • Leiden

On-site
EUR 130,000 - 180,000
Competitive year salary
8.33% holiday allowance
30 vacation days
+1
TPM QA Manager – EMEA Quality Leadership
TPM QA Manager – EMEA Quality Leadership

Abbott Laboratories • Netherlands

Remote
EUR 90,000 - 130,000
Quality Assurance Specialist
Quality Assurance Specialist

SIRE LIFE SCIENCES • Haarlem

On-site
EUR 65,000 - 90,000