Global Quality Systems Leader | QMS, CAPA & Change Control

Sun Pharmaceutical Industries

Billerica (MA)

On-site

USD 137,000 - 168,000

Full time

3 days ago

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Job summary

Sun Pharmaceutical Industries seeks a Senior Manager, Quality Systems to lead and enhance quality systems ensuring global regulatory compliance. You will oversee deviations, CAPA, change control, training, document management and audit readiness across GDO and supporting functions.

You will collaborate across functions as QA lead, author SOPs, align documents with GxP, and support audits/regulatory inspections. Travel up to 15% is expected.

Qualifications

Bachelor's degree in Life Sciences or related field required.
Minimum 8–10 years of QA experience in a regulated industry.
Experience with electronic QMS platforms and global teams.
Strong knowledge of FDA/EMA/ICH and GxP principles.

Responsibilities

Lead development, implementation, and maintenance of core quality systems.
Serve as QA lead and system owner for Deviation, CAPA, Change Control, Training, and Document Management.
Author and approve SOPs, policies, and training materials.
Ensure documents comply with GxP and global regulatory standards.
Support internal/external audits and regulatory inspections.
Lead risk assessments and quality impact evaluations for changes.
Develop and monitor quality metrics and KPIs.

Skills

Quality systems

Cross-functional

SOPs & training

Regulatory compliance

Data governance

Lean Six Sigma

Education

Bachelor's degree in Life Sciences

Quality management cert

Tools

Electronic QMS

Job description

You will collaborate across functions as QA lead, author SOPs, align documents with GxP, and support audits/regulatory inspections. Travel up to 15% is expected.

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