Senior Quality Systems & Compliance Leader

PPL Healthcare LLC; Sellersville (Bucks County); On-site; USD 120,000 - 190,000; Full time

Job summary

Piramal Pharma Limited is seeking a Sr. Manager Quality Systems & Compliance in Bucks County, PA to oversee site QA systems and ensure cGMP conformity. You will lead audits, CAPA programs, document control, and regulatory interactions to sustain quality and compliance throughout operations.

The role requires extensive QA leadership experience, strong knowledge of GMP regulations (21 CFR parts 11/210/211, Annex 11, ICH Q7/9/10), and proficiency with TrackWise, SAP and MasterControl.

Qualifications

• Bachelor's degree in the physical or biological sciences or engineering; Chemistry/Chemical Engineering preferred.

Responsibilities

• Audits: support internal/external audits and regulatory inspections; participate in responses and retain inspections.
• Quality Systems: oversee CAPAs, document reviews, environmental monitoring, quality metrics and trackwise events.
• Metrics: perform routine/ad hoc quality systems reporting and trend analysis.
• Risk Management: participate in risk management activities and maintain risk documents.
• Training/Management: manage QA Systems team and training records.

Skills

Organizational skills

Communication skills

Leadership

Regulatory knowledge

Education

Bachelor's degree in physical or biological sciences or engineering

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Limited is seeking a Sr. Manager Quality Systems & Compliance in Bucks County, PA to oversee site QA systems and ensure cGMP conformity. You will lead audits, CAPA programs, document control, and regulatory interactions to sustain quality and compliance throughout operations.

The role requires extensive QA leadership experience, strong knowledge of GMP regulations (21 CFR parts 11/210/211, Annex 11, ICH Q7/9/10), and proficiency with TrackWise, SAP and MasterControl.