Business: Piramal Pharma Solutions
Department: Quality Assurance
Location: Sellersville
Position Summary: The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at PPL Healthcare LLC - Sellersville. This position will support overall cGMP and regulatory compliance at the site by ensuring that the quality systems are used effectively to support the company quality policy and objectives while driving continuous improvement.

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:

• In depth knowledge of global pharmaceutical regulations (e.g., FDA, EMA, PDMA, ANVISA, TGA, DEA)
• In depth knowledge of Quality Management Systems and Quality Compliance for non-sterile pharmaceutical manufacturing
• Experience with eQMS including DMS, LMS, and eBMR.

• Experience with audit, supplier management, and data integrity.Strong teamwork and communication skills

MINIMUM EDUCATION QUALIFICATION

• Bachelor degree or higher in relevant scientific quality assurance/technical field

FUNCTIONAL OR TECHNICAL SKILLS

• Ability to organize time and drive project tasks for multiple areas (major projects and daily functions). Good written, verbal and interpersonal communication skills. Basic computer skills such as Microsoft Office

MINIMUM EXPERIENCE (IN YEARS)

10+ years’ experience in a Manufacturing environment, QA, Quality Systems, and/or Compliance experience in a cGMP/FDA regulated environment with 5 or more years in a supervisor/manager role.

• Maintain eQMS platforms and act as a system administrator (e.g. ComplianceWire, TrackWise, Ensur, eBMR, eForms).
• Training Program
• Oversee all site training activities and provide guidance and training to end-users.
• Build training programs working with department heads and SMEs to create and revise training curricula.
• Document Control
• Oversee SOP program.
• Responsible for document management (e.g., Master Batch Record, protocol
• Review and approve quality system records in Trackwise
• Compliance Systems
• Provide guidance and work with stakeholders from various departments for on-time completion of quality system records such as deviations, CAPAs, Change Controls, and training records.
• Annual Product Review (APRs)
• Lead QSC review boards such as Deviation Review Board, CAPA Review Board, Change Control Review Board
• Provide quality systems metrics on weekly, monthly and quarterly basis.
• Complaint/FAR/Recall management
• Quality Technical Agreements (QTAs)
• Supplier Management Program
• Audit Management Program (Internal, External, Client, and Regulatory Authorities)
• Data Integrity Program
• Manage Computer System Validation (CSV) program.
• Site Data Integrity Compliance Officer (DICO) with responsibility over data integrity program.
• Support site quality improvement projects and electronic systems implements/ updates.
• Work with corporate quality team for continuous improvement and implementation of Global Policies and Procedures
• Adhere to set safety standards.Other QSC activities as assigned.