Piramal Pharma Solutions is seeking an experienced Manager, Quality Systems & Compliance to lead and maintain robust quality systems and ensure compliance with global regulatory requirements at our Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products.

The successful candidate will ensure quality systems are effectively implemented, aligned with company quality policies, and continuously improved to meet evolving regulatory and business needs.

Key Responsibilities

Quality Systems Leadership

• Serve as system administrator for electronic Quality Management Systems (eQMS), including ComplianceWire, TrackWise, Ensur, eBMR, and eForms.
• Ensure effective use of quality systems to support site compliance and continuous improvement initiatives.
• Review and approve quality system records, including deviations, CAPAs, change controls, and training records.

Training Program Management

• Oversee all site training activities and ensure compliance with regulatory and internal requirements.
• Partner with department heads and SMEs to develop, implement, and maintain training curricula.
• Provide guidance and training to end users on quality systems and processes.

Document Control

• Manage the site SOP program and overall document control lifecycle.
• Oversee document management activities, including Master Batch Records and protocols.

Compliance & Governance

• Lead Quality System Committees (QSCs) and review boards, including Deviation, CAPA, and Change Control Review Boards.
• Provide quality system metrics on a weekly, monthly, and quarterly basis.
• Manage Annual Product Reviews (APRs).
• Oversee complaint, FAR, and recall management processes.
• Manage Quality Technical Agreements (QTAs).

Audit & Supplier Management

• Lead the Supplier Management Program.
• Manage internal, external, client, and regulatory audits.
• Actively support regulatory inspections and client audits.

Data Integrity & Computer Systems

• Serve as Site Data Integrity Compliance Officer (DICO).
• Manage the site Data Integrity Program.
• Oversee the Computer System Validation (CSV) program.
• Support implementation and upgrades of electronic systems.

Continuous Improvement

• Collaborate with the corporate quality team to implement global policies and procedures.
• Support site quality improvement initiatives and special projects.
• Ensure adherence to site safety standards.
• Perform additional Quality Systems & Compliance activities as assigned.

Required Qualifications

Education

• Bachelor’s degree or higher in a scientific, quality assurance, or technical discipline.

Experience

• Minimum of 10+ years in a manufacturing environment with QA, Quality Systems, and/or Compliance experience in a cGMP/FDA-regulated industry.
• At least 5 years in a supervisory or managerial role.

Technical & Functional Skills

• In-depth knowledge of global pharmaceutical regulations (FDA, EMA, PDMA, ANVISA, TGA, DEA).
• Strong understanding of Quality Management Systems for non-sterile pharmaceutical manufacturing.
• Hands-on experience with eQMS platforms (DMS, LMS, eBMR).
• Proven experience in audits, supplier management, and data integrity.
• Excellent organizational, communication, and cross-functional collaboration skills.
• Proficient in Microsoft Office and standard business systems.
• Ability to manage multiple projects and priorities simultaneously.