Global CAPA Program Leader

CooperSurgical

Trumbull (CT)

On-site

USD 120,000 - 170,000

Full time

14 days+

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Benefits offered by this job

Medical coverage
401(k)
Parental leave
Fertility benefits
Paid time off

Job summary

CooperSurgical is seeking a Manager, Global CAPA System to ensure compliance and product quality through effective CAPA processes. The successful candidate will lead the global CAPA program and collaborate with various departments to enhance quality management. Requirements include 8+ years of quality experience and a Bachelor’s degree in a relevant field. Benefits include medical coverage and a competitive salary between $120,000 and $170,000 annually.

Qualifications

  • 8+ years of progressive quality experience in a regulated industry.
  • 3-5 years directly supporting or managing CAPA systems.
  • 5+ years of QA leadership experience.

Responsibilities

  • Own and maintain the global CAPA program.
  • Ensure alignment of CAPA processes with regulatory requirements.
  • Lead high-performing global and site CAPA teams.
  • Develop and maintain global CAPA KPIs.

Skills

CAPA management expertise
Root cause analysis
Regulatory compliance knowledge
Data analysis
Strong communication skills
Electronic Quality Management Systems (eQMS)

Education

Bachelor’s degree in Engineering, Life Sciences, Chemistry, or related discipline

Tools

TrackWise
Veeva
MasterControl

Job description

CooperSurgical is seeking a Manager, Global CAPA System to ensure compliance and product quality through effective CAPA processes. The successful candidate will lead the global CAPA program and collaborate with various departments to enhance quality management. Requirements include 8+ years of quality experience and a Bachelor’s degree in a relevant field. Benefits include medical coverage and a competitive salary between $120,000 and $170,000 annually.
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