QA Manager Clinical Operations

Piramal Pharma Solutions is looking for a dedicated QA Manager to oversee Clinical Operations at our Sellersville site. In this role, you will lead quality assurance initiatives, ensuring compliance with GMP regulations and maintaining our Quality Management System (QMS). You will be responsible for guiding a team of quality professionals, identifying areas for process improvement, and implementing best practices to enhance operational efficiency. The ideal candidate will have a strong background in pharmaceutical quality assurance, excellent leadership skills, and a commitment to upholding the highest quality standards. Join us in our mission to deliver innovative pharmaceutical solutions and make a significant impact on patient careRoleThe quality manager provides leadership and guidance for the department, works to improve core processes, and manage projects. Ensure the staff is qualified in all quality area functions and that the QMS is maintained to applicable GMP requirements.Identify areas of continuous improvement within the Quality department and in the Quality Management System.Evaluate metrics for trends to better focus on areas requiring improvement. Develop goals for the Quality Assurance team to drive improvement and monitor for effectiveness.Develop and perform training for the Quality team as well as other departments in areas of the PPS QMS and GMP requirements.Support the Quality teams in regard to projects including but not limited to commercial and clinical batches, Operational, QC, and QMS projectsLead and support with customer requests, quality events, QTAs, and complaints.Maintain an electronic documentation control system assuring all documents are current. Act as the Ensur system administrator.Support the teams as the system SME and/or administrator for creating CAPAs, change controls, deviations, and laboratory investigations.Exhibit strong communication and problem solving skills while leading the Quality Assurance department toward company goals and objectives.Provide guidance and leadership to the QA Specialists with input into their performance and goalsProvides compliance support and expertise for QA departmentSupports the execution of audit readiness program to ensure compliance ready state at all time to Customer and Regulatory audits.Maintains tracking mechanisms to support various QA related metricsContinuously monitors and reviews QA systems and procedures for adherence to regulatory compliance, quality improvements, efficiency and industry best practiceParticipates in site quality and process improvement initiatives. Represents QA on site project teamsEffectively lead team to deliver goals/results. Provides coaching and the necessary resources to area management to meet department objectivesConducts interviews and hires qualified candidates to fill open technical and support positionsConducts performance and development reviewsProvides direction and leadership for the QA team in compliance, systems, commercial, pre commercial processes, support for development, manufacturing and supply chain operations.Develops and manages daily work schedule for QA Specialists to meet QA deliveries schedules and needs.Ensures QA documentation and batch release is completed by due dates and project timeline.Leads the design, implementation and continuous improvement of QA Operations, Systems and Compliance to promote efficient and compliant operationsProvides support for implementation of new and key process optimization.QualificationsBachelor degree or higher in relevant scientific quality assurance/technical field and 5 years experience in a Manufacturing environmentAbility to organize time for multiple tasks (major projects and daily functions)Good written, verbal and interpersonal communication skillsProficient computer skills, such as Microsoft Office, including TeamsLeadership skills: Building the best team; business insight; strategic mindset; problem-solving; resource management7+ years experience in a manufacturing Quality role.