Senior Quality Systems & Compliance Leader

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

Job summary

Piramal Pharma Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead QA activities, ensuring cGMP compliance across the site. The role oversees audits, CAPAs, documentation, and quality metrics while guiding a team of QA professionals.

The ideal candidate will have a strong background in GMP, regulatory interactions with FDA, and extensive experience in quality systems and risk management within a pharmaceutical environment.

Qualifications

• Bachelor's degree in the physical or biological sciences or engineering; Chemistry/Chemical Engineering preferred.
• Minimum ten years in pharmaceutical operations, regulated life sciences, or quality assurance with supervisory experience.
• Minimum five years 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

• Audit support for internal and regulatory inspections.
• Prepare or review Annual Product Reviews, Non-Conforming Material Reports, Investigation Reports and validation documentation.
• Oversee CAPAs, document reviews, environmental monitoring, quality metrics and quality agreements.
• Perform routine quality systems reporting, trend analysis and management review support.
• Participate in risk management and maintain risk documentation.
• Manage the QA Systems team and training activities.

Skills

Auditing

Regulatory knowledge

Leadership

Communication

Analytical skills

FDA interactions

Education

Bachelor's degree in sciences/engineering

Tools

TrackWise

SAP

MasterControl

Job description

Piramal Pharma Solutions is seeking a Sr. Manager Quality Systems & Compliance to lead QA activities, ensuring cGMP compliance across the site. The role oversees audits, CAPAs, documentation, and quality metrics while guiding a team of QA professionals.

The ideal candidate will have a strong background in GMP, regulatory interactions with FDA, and extensive experience in quality systems and risk management within a pharmaceutical environment.