Senior QA Lead: Customer & Project Quality

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Competitive health benefits

Retirement plan

Job summary

Piramal Pharma Solutions is hiring a Senior Quality Assurance Specialist to lead customer‑facing QA activities within development, validation, and manufacturing programs. The role works with project teams to ensure cGMP compliance, track actions, and maintain clear documentation.

You will manage batch disposition, deviations, and CAPAs while supporting audits and quality agreements. The ideal candidate has 5+ years of QA experience in regulated life sciences, familiarity with CDMO environments,

Qualifications

• Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Life Sciences, or a related scientific discipline.
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• Minimum five (5) years of Quality Assurance experience in pharma/regulated life sciences including cGMP.
• CDMO/CMO experience preferred for multi‑customer support.
• Experience supporting customer‑facing Quality activities with cross‑functional teams.
• Working knowledge of 21 CFR Parts 210/211, EU GMP, ICH guidance and data integrity expectations.
• Experience with electronic Quality systems (TrackWise, MasterControl, Veeva, SAP) is preferred.

Responsibilities

• Serve as the day‑to‑day customer QA contact and coordinate responses.
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• Plan, prioritize and drive QA activities aligned with project plans and milestones.
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• Review batch records, deviations, investigations, and release documentation for disposition.
• 4
• Coordinate audits, CAPAs, APQRs/PQRs, and customer communications.
• 5
• Maintain dashboards and trackers for release cycle time, quality events, and commitments.

Skills

Quality assurance

Regulatory knowledge

Documentation

Risk management

Cross-functional collaboration

Customer communications

Education

Bachelor’s degree in Chemistry,Biology,... (see HTML)

Tools

TrackWise

MasterControl

Veeva

SAP

Job description

Piramal Pharma Solutions is hiring a Senior Quality Assurance Specialist to lead customer‑facing QA activities within development, validation, and manufacturing programs. The role works with project teams to ensure cGMP compliance, track actions, and maintain clear documentation.

You will manage batch disposition, deviations, and CAPAs while supporting audits and quality agreements. The ideal candidate has 5+ years of QA experience in regulated life sciences, familiarity with CDMO environments,