Senior Quality & Compliance Auditor, QMS Lead

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 110,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions is a leading CDMO providing end-to-end development and manufacturing services for the drug life cycle. The Sr.

Quality Specialist, QMS & Compliance, will lead the site audit program, manage internal and external audits, and support regulatory inspections to ensure inspection readiness and robust quality systems. The role requires seven years in pharmaceutical QA, strong knowledge of DEA and cGMP, and experience with TrackWise/SAP/MasterControl.

Qualifications

• Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Life Sciences, Engineering, Quality or related scientific discipline is required.
• Minimum seven (7) years of experience in pharmaceutical QA, Quality Systems, compliance or operations in a cGMP environment.
• Demonstrated experience planning, conducting, documenting and following up on internal, customer, supplier or regulatory audits.

Responsibilities

• Lead site audit program aligned with annual plan and risk priorities.
• Plan and conduct internal audits and self-inspections across multiple functions.
• Manage customer audits including readiness meetings and documentation requests.
• Support FDA, DEA and other health-authority inspections and external audits.
• Coordinate responses to audit observations and track CAPAs to closure.
• Develop and maintain audit dashboards and management reports.

Skills

Audit management

Regulatory compliance

Quality assurance

DEA knowledge

cGMP knowledge

Education

Bachelor’s degree in Chemistry, Pharmacy, Biology, Microbiology, Life Sciences, Engineering, Quality or related field

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Solutions is a leading CDMO providing end-to-end development and manufacturing services for the drug life cycle. The Sr.

Quality Specialist, QMS & Compliance, will lead the site audit program, manage internal and external audits, and support regulatory inspections to ensure inspection readiness and robust quality systems. The role requires seven years in pharmaceutical QA, strong knowledge of DEA and cGMP, and experience with TrackWise/SAP/MasterControl.