Senior Quality & Compliance Lead, QMS & Audits

Piramal Pharma Limited; Pennsylvania; On-site; USD 90,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Sr. Quality Specialist, QMS & Compliance to lead site audits, supplier qualification and DEA compliance within a CDMO environment.

You will partner with cross-functional teams to ensure findings, corrective actions and documentation are accurate, timely and inspection-ready. The role requires 7+ years in pharmaceutical quality systems, strong regulatory knowledge and data-analytics capability.

Qualifications

• Education: Bachelor’s in Chemistry, Pharmacy, Biology, Microbiology, Life Sciences, Engineering, Quality or related field.
• Experience: Seven+ years in pharmaceutical Quality Assurance, Quality Systems, compliance or operations in a cGMP environment.
• Auditing: Experience planning, conducting, documenting internal, customer or regulatory audits.

Responsibilities

• Execute the site audit program per the approved annual plan and manage schedules, records, and metrics.
• Plan and conduct risk-based internal audits and self-inspections across Quality, Manufacturing, QC and supporting functions.
• Coordinate customer, regulatory and supplier audits, including readiness, documentation requests and responses.
• Support FDA, DEA and other inspections through inspection-readiness activities and file retrieval.
• Track CAPAs, corrective actions and commitments to closure with evidence and effectiveness checks.
• Develop and maintain audit dashboards and management-review reports to monitor trends and compliance.

Skills

Audit planning

Regulatory knowledge

Quality systems

Data analytics

Cross-functional collaboration

Risk assessment

Education

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

Tools

TrackWise

SAP

MasterControl

Power BI

Job description

Piramal Pharma Solutions is seeking a Sr. Quality Specialist, QMS & Compliance to lead site audits, supplier qualification and DEA compliance within a CDMO environment.

You will partner with cross-functional teams to ensure findings, corrective actions and documentation are accurate, timely and inspection-ready. The role requires 7+ years in pharmaceutical quality systems, strong regulatory knowledge and data-analytics capability.