Piramal Pharma Solutions · 1 day ago
Manager Quality Systems & Compliance
Sellersville, PA
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expPiramal 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 their Sellersville site. This role is critical in supporting cGMP and regulatory compliance across manufacturing, testing, warehousing, and distribution operations for pharmaceutical drug products.
Health CarePharmaceuticalTherapeutics
Hiring Manager
Kris P.
Responsibilities
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
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
Manage the site SOP program and overall document control lifecycle
Oversee document management activities, including Master Batch Records and protocols
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)
Lead the Supplier Management Program
Manage internal, external, client, and regulatory audits
Actively support regulatory inspections and client audits
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
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
Qualification
Required
Bachelor's degree or higher in a scientific, quality assurance, or technical discipline
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
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
Company
Piramal Pharma Solutions
Piramal Pharma Solutions offers end-to-end services required to bring a drug into the marketplace efficiently. It is a sub-organization of Piramal Group.
1001-5000 employees
H1B Sponsorship
Piramal Pharma Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (11)
2023 (4)
2022 (12)
2021 (10)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Herve Berdou
Chief Operating Officer
Recent News
Morningstar.com
2025-12-15
Precedence Research
2025-12-01
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