Senior Quality Systems & Compliance Lead

piramalpharma; Sellersville (Bucks County); On-site; USD 140,000 - 180,000; Full time

Job summary

Piramal Pharma Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead quality systems across the site, ensuring QA activities meet cGMP and regulatory requirements.

The role emphasizes audits, CAPAs, document control, and continuous improvement, with oversight of regulatory inspections and QA metrics. The candidate should bring extensive QA leadership experience, familiarity with TrackWise, SAP and MasterControl, and strong collaboration with cross-functional teams to maintain

Qualifications

• Bachelor's degree in the physical or biological sciences or engineering.
• Minimum ten (10) years experience in pharmaceutical operations, regulated life sciences, or quality assurance with 2-5 years supervisory experience.
• Minimum five (5) years experience in QA leadership.
• Knowledge of GMP requirements (21 CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
• Strong computer skills with Microsoft Office, databases, reporting and statistical tools.
• Proficient in TrackWise, SAP and MasterControl.

Responsibilities

• Audits: support internal and external audits and regulatory inspections; conduct audits and inspections; oversee corrective actions.
• Reports/Document Management: prepare or review Annual Product Reviews, Non-Conforming Material Reports, Investigation Reports and validation documentation.
• Quality Systems: oversee CAPAs, document reviews, environmental monitoring, quality metrics, quality agreements, TrackWise events, deviations, OOS/OOT investigations, and procedure maintenance.
• Metrics: perform routine and ad hoc quality systems reporting, trend analysis and management review support.
• Risk Management: participate in risk management activities and maintain risk documentation.
• Training/Management: manage the QA Systems team, training activities, training records and training module development.

Skills

QA leadership

GMP knowledge

Audits & inspections

SOP compliance

Regulatory communication

Education

Bachelors in physical/biological sciences or engineering

Chemistry/Chemical Engineering preferred

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead quality systems across the site, ensuring QA activities meet cGMP and regulatory requirements.

The role emphasizes audits, CAPAs, document control, and continuous improvement, with oversight of regulatory inspections and QA metrics. The candidate should bring extensive QA leadership experience, familiarity with TrackWise, SAP and MasterControl, and strong collaboration with cross-functional teams to maintain