Business: Piramal Pharma Solutions Department: QA Location: Sellersville, PA Travel: N/A Job Overview The primary objective of the role is to provide Quality Operations support for both Clinical and Commercial Operations. Support includes data auditing for Quality Control operations such as raw material, finished good, stability and laboratory equipment qualification. QA IT support for the site to assure all production, laboratory equipment and software implementation meeting computer software regulatory requirements (21 CFR Part 11, Annex 11, GAMP 5). This role will be critical point of contact with respect to clients to provide leadership and key updates for all Quality Operational activities. Key Stakeholders: Internal * Technical Operation * Supply Chain * Quality Control, Quality Systems and Compliance * Engineering and Facilities * Analytical and Formulation Research and Development * Project Management * Business Unit Key Stakeholders: External * Clients - Commercial and Clinical * Various Regulators including FDA, EU and PMDA Reporting Structure Reports to Director of Quality KEY ROLES/RESPONSIBILTIES Direct oversight of the following functions: * Personnel Development * Commercial Operations * Clinical Operations * Data Auditing * QA IT Direct oversight of Quality Assurance, ensures the activities are performed and closed in a timely manner, specifically: * Deviations (Events) * CAPA * Change Control * Review and approve controlled documents requiring QA approval signature, including: * Executed cGMP Batch Records * Master Batch Production Records * Standard Operating Procedures * Product, Process, Test Method, and Equipment Qualification Protocols * Participate in client project meetings as well as PPS project meeting * Development and issuance of operational metrics related to record execution * Serve as the Subject Matter Expert (SME) on Quality Operational support activities * Accountable for the effective execution of processes carried out under departmental leaders (Pest Control, GMP Work Orders, Batch Disposition and Operational Quality Walk Through) * Establish and track the relevant KPIs * Periodic "stand-in" stand-in for Head of Quality duties, as designated * Coordinates daily and monthly staffing schedules, capacity planning and cross-training efforts * Assists QA management with identifying staffing needs and contributes to hiring decisions * Provide scheduling of data auditing to align with client objectives * Provide direction of CSV support needed for the site to ensure business continuity and support new equipment induction activities as well as an updates to software/hardware that are critical to the business * Support/execute Supplier Management Program * Support/execute Annual Product Review * Manage Departmental Budget * Support, serve as Subject Matter Expert for: internal, customer and regulatory audits/inspections * Execute system/process gap analysis and implement CAPAs for identified gaps