Piramal Pharma Ltd
Manager Quality Systems & Compliance
Piramal Pharma Ltd, Sellersville, Pennsylvania, United States
Overview
Manager Quality Systems & Compliance at Piramal Pharma Ltd (Piramal Pharma Solutions), located in Sellersville. This role ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at PPL Healthcare LLC - Sellersville. The position supports cGMP and regulatory compliance at the site and drives continuous improvement. Responsibilities
Maintain and administer eQMS platforms (e.g., ComplianceWire, TrackWise, Ensur, eBMR, eForms). Oversee site training activities; develop and revise training curricula with department heads and SMEs. Oversee SOP program and document management (e.g., Master Batch Records, protocols); review and approve quality system records in TrackWise. Provide guidance to stakeholders for on-time completion of deviations, CAPAs, Change Controls, and training records. Lead and participate in quality system boards (e.g., APRs, Deviation Review Board, CAPA Review Board, Change Control Review Board). Provide quality system metrics on weekly, monthly, and quarterly bases; manage Supplier Management Program, Audit Management Program, Data Integrity Program. Manage Data Integrity Program including CSV; Site DICO with responsibility over data integrity. Manage Complaints/FAR/Recall; maintain Quality Technical Agreements (QTAs); support site quality improvement projects and electronic system implementations/updates. Work with corporate quality team for continuous improvement and Global Policies/Procedures; adhere to safety standards. Other QSC activities as assigned. Qualifications
Bachelor degree or higher in a relevant scientific, quality assurance, or technical field. In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA); strong knowledge of Quality Management Systems and quality compliance for non-sterile pharmaceutical manufacturing. Experience with eQMS including DMS, LMS, and eBMR; audit, supplier management, and data integrity. Ability to organize time and drive projects across multiple areas; strong written, verbal, and interpersonal communication skills; basic Microsoft Office skills. Experience
10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance in a cGMP/FDA-regulated setting; 5+ years in a supervisor/manager role. Seniorities
Mid-Senior level Employment Type
Full-time Job Function
Quality Assurance Industries
Pharmaceutical Manufacturing
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Manager Quality Systems & Compliance at Piramal Pharma Ltd (Piramal Pharma Solutions), located in Sellersville. This role ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at PPL Healthcare LLC - Sellersville. The position supports cGMP and regulatory compliance at the site and drives continuous improvement. Responsibilities
Maintain and administer eQMS platforms (e.g., ComplianceWire, TrackWise, Ensur, eBMR, eForms). Oversee site training activities; develop and revise training curricula with department heads and SMEs. Oversee SOP program and document management (e.g., Master Batch Records, protocols); review and approve quality system records in TrackWise. Provide guidance to stakeholders for on-time completion of deviations, CAPAs, Change Controls, and training records. Lead and participate in quality system boards (e.g., APRs, Deviation Review Board, CAPA Review Board, Change Control Review Board). Provide quality system metrics on weekly, monthly, and quarterly bases; manage Supplier Management Program, Audit Management Program, Data Integrity Program. Manage Data Integrity Program including CSV; Site DICO with responsibility over data integrity. Manage Complaints/FAR/Recall; maintain Quality Technical Agreements (QTAs); support site quality improvement projects and electronic system implementations/updates. Work with corporate quality team for continuous improvement and Global Policies/Procedures; adhere to safety standards. Other QSC activities as assigned. Qualifications
Bachelor degree or higher in a relevant scientific, quality assurance, or technical field. In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA); strong knowledge of Quality Management Systems and quality compliance for non-sterile pharmaceutical manufacturing. Experience with eQMS including DMS, LMS, and eBMR; audit, supplier management, and data integrity. Ability to organize time and drive projects across multiple areas; strong written, verbal, and interpersonal communication skills; basic Microsoft Office skills. Experience
10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance in a cGMP/FDA-regulated setting; 5+ years in a supervisor/manager role. Seniorities
Mid-Senior level Employment Type
Full-time Job Function
Quality Assurance Industries
Pharmaceutical Manufacturing
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