Manager, Quality Assurance
About The Position
Piramal Pharma Solutions is seeking a Quality Assurance Manager for its pharmaceutical manufacturing facility in Sellersville, Pennsylvania. The role leads Quality Assurance operations supporting commercial manufacturing, product disposition, investigations, quality systems, and regulatory compliance. It oversees Quality Assurance personnel and works closely with Manufacturing, Quality Control, Engineering, Supply Chain, and other site functions to ensure compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. The position also supports continuous improvement initiatives, regulatory inspections, customer audits, and site quality objectives. The successful candidate is expected to follow applicable regulatory requirements and safety, health, and environmental procedures; uphold company mission, vision, and values; protect proprietary and technical information; and demonstrate commitment to quality, compliance, operational excellence, and continuous improvement. The work involves pharmaceutical manufacturing operations and supporting quality systems, with occasional support outside normal business hours for inspections, investigations, or critical operational needs.
Requirements
- Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline.
- At least 8 years of experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments.
- At least 3 years of supervisory or management experience within a Quality Assurance organization.
- Experience supporting batch disposition, deviations, investigations, CAPAs, change controls, and quality systems.
- Experience supporting commercial manufacturing operations.
- Strong working knowledge of cGMP regulations and Data Integrity requirements.
- Proficiency with Microsoft Office applications.
- Strong knowledge of cGMP regulations and pharmaceutical quality systems.
- Leadership and employee development skills.
- Strategic thinking and sound judgment.
- Root cause analysis and problem-solving skills.
- Risk assessment and mitigation skills.
- Strong written and verbal communication skills.
- Cross-functional collaboration and relationship-building skills.
- Continuous improvement mindset.
- Organizational and project management skills.
- Customer-focused approach.
- Ability to prioritize and manage multiple initiatives simultaneously.
- Commitment to quality and regulatory compliance.
- Ability to meet the physical demands of the role, including frequent lifting, bending, stooping, squatting, pushing, and pulling; prolonged standing and walking; and extended periods of sitting, typing, computer entry, documentation review, and meetings.
- Ability to access manufacturing, warehouse, and laboratory areas as needed.
Nice To Haves
- Experience supporting FDA inspections and customer audits.
- Experience with electronic quality management systems such as TrackWise, MasterControl, Veeva, or similar platforms.
Responsibilities
- Manage and supervise Quality Assurance personnel responsible for batch record review, product disposition, investigations, and quality system activities.
- Ensure timely review and disposition of commercial product batches in accordance with approved procedures and regulatory requirements.
- Provide quality oversight and support for commercial manufacturing operations.
- Review and approve deviations, investigations, CAPAs, change controls, and other quality system documentation.
- Lead root cause investigations and ensure effective corrective and preventive actions are implemented.
- Support product launches, process improvements, and continuous improvement initiatives.
- Participate in cross-functional teams focused on product quality, compliance, and operational excellence.
- Monitor, trend, and communicate quality metrics to site leadership.
- Support FDA inspections, customer audits, and regulatory agency interactions.
- Ensure departmental compliance with cGMP requirements and company quality systems.
- Recruit, train, coach, develop, and evaluate Quality Assurance personnel.
- Manage departmental objectives and ensure alignment with site and corporate goals.
- Serve as a technical resource and subject matter expert for quality-related matters.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
