Senior Quality Systems & Compliance Leader

Piramal Pharma Limited; Sellersville (Bucks County); On-site; USD 120,000 - 180,000; Full time

Job summary

Piramal Pharma Limited, via Piramal Pharma Solutions, seeks a Sr. Manager Quality Systems & Compliance to lead Quality Assurance activities at the site, ensuring cGMP compliance, adherence to SOPs and regulatory requirements.

The role oversees audits, document management, CAPAs, training and risk management, mentoring the QA team, and delivering QA metrics and improvements in a fast-paced CDMO environment.

Qualifications

• Bachelor's degree in physical or biological sciences or engineering.
• Ten+ years of experience in pharmaceutical operations, regulated life sciences, or quality assurance with 2-5 years of supervisory experience.
• Minimum five years experience in QA leadership.
• Knowledge of GMP requirements (21 CFR Part 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, regulatory inspections, ensure corrective actions and retain inventory.
• 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, procedure maintenance and gap assessments.
• Metrics: Perform routine and ad hoc quality systems reporting, trend analysis and management review support.
• Risk Management: Participate in risk management activities and maintain appropriate risk documentation.
• Training/Management: Manage the QA Systems team, training activities, training records and training module development.

Skills

Organizational skills

Communication skills

Analytical skills

FDA/regulatory interaction

Manufacturing quality knowledge

Independent task execution

Education

Bachelor's degree in physical/biological sciences or engineering

10+ years in pharmaceutical operations/regulatory life sciences

5+ years QA leadership experience

GMP knowledge (21 CFR Parts 11, 210, 211, Annex 11; ICH Q7/9/10)

Strong computer skills (Office, databases, statistics)

Proficient in TrackWise, SAP, MasterControl

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Limited, via Piramal Pharma Solutions, seeks a Sr. Manager Quality Systems & Compliance to lead Quality Assurance activities at the site, ensuring cGMP compliance, adherence to SOPs and regulatory requirements.

The role oversees audits, document management, CAPAs, training and risk management, mentoring the QA team, and delivering QA metrics and improvements in a fast-paced CDMO environment.