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 cGMP, regulatory requirements, and company quality standards. The position also supports continuous improvement, regulatory inspections, customer audits, and site quality objectives. The successful candidate must adhere to applicable regulatory requirements, including FDA, EPA, and OSHA requirements and related safety, health, and environmental policies. The role requires support of Piramal Pharma Solutions’ mission, vision, and values; protection of proprietary and technical information; and commitment to quality, compliance, operational excellence, and continuous improvement. A bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or a related scientific discipline and at least eight years of experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing are required. Candidates must also have at least three years of supervisory or management experience within Quality Assurance, along with experience supporting batch disposition, quality-system activities, and commercial manufacturing. The position requires strong knowledge of cGMP and pharmaceutical quality systems, leadership and employee-development skills, sound judgment, problem-solving and risk-assessment abilities, communication and collaboration skills, and the ability to manage multiple initiatives. The role involves frequent lifting, bending, stooping, squatting, pushing, and pulling; extended standing and walking when supporting manufacturing operations; and extended sitting, typing, computer entry, documentation review, and meetings. The employee must be able to access manufacturing, warehouse, and laboratory areas as needed. The work environment is in and near pharmaceutical manufacturing operations and supporting quality systems, with potential limited exposure to hazardous chemicals and pharmaceutical materials. Personal protective equipment may be required in designated areas. Occasional support outside normal business hours may be needed during 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 perform the described essential functions, with reasonable accommodations available as applicable.
Nice To Haves
- Experience supporting FDA inspections and customer audits.
- Experience using 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 align them with site and corporate goals.
- Serve as a technical resource and subject matter expert for quality-related matters.
- Adhere to applicable regulatory requirements and related safety, health, and environmental procedures, policies, and practices.
- Protect proprietary and technical information as company property.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
