Manager, Quality Assurance

Job TitleManager, Quality AssuranceJob DescriptionPiramal Pharma Solutions' pharmaceutical manufacturing facility, located in Sellersville, Pennsylvania, is seeking a qualified Quality Assurance Manager to join our Quality Assurance Department. The Quality Assurance Manager is responsible for leading Quality Assurance operations that support commercial manufacturing activities, product disposition, investigations, quality systems, and regulatory compliance. This role provides oversight of Quality Assurance personnel and partners 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 supports continuous improvement initiatives, regulatory inspections, customer audits, and site quality objectives. To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices. Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values. Identify and protect proprietary and technical information as company property. Demonstrate a commitment to quality, compliance, operational excellence, and continuous improvement.**Key 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. **Education/Experience**The successful candidate must meet one of the following education/experience combinations:* Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related scientific discipline required.* Minimum of 8 years of experience in pharmaceutical, biotechnology, or other GMP-regulated manufacturing environments.* Minimum of 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.* Experience with FDA inspections and customer audits preferred.* Strong working knowledge of cGMP regulations and Data Integrity requirements.* Experience using electronic quality management systems such as TrackWise, MasterControl, Veeva, or similar platforms preferred.* Proficiency with Microsoft Office applications. Job competencies. * Strong knowledge of cGMP regulations and pharmaceutical quality systems.* Leadership and employee development.* Strategic thinking and sound judgment.* Root cause analysis and problem-solving skills.* Risk assessment and mitigation.* Strong written and verbal communication skills.* Cross-functional collaboration and relationship building.* 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. **Job conditions.** The physical demands and work environment described here are representative of those that must be met by a team member to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. If any accommodations are needed, requests should be made to our Human Resources department. ***Physical Demands**:** Frequent lifting, bending, stooping, squatting, pushing and pulling may be required.* Long periods of standing and walking may be required when supporting manufacturing operations.* This position requires extended periods of sitting, typing, computer entry, reviewing documentation, and attending meetings.* Ability to access manufacturing, warehouse, and laboratory areas as needed. ***Work Environment**:** Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing. As such, all employees work in our near pharmaceutical manufacturing operations and supporting quality systems.* Potential limited exposure to hazardous chemicals and pharmaceutical materials.* Personal protective equipment including safety glasses, lab coats, gloves, gowning, and safety footwear may be required in designated areas.* Frequent interaction with manufacturing, laboratory, engineering, and technical services personnel.* Occasional support outside normal business hours may be required during inspections, investigations, or critical operational needs. #J-18808-Ljbffr