This leadership role provides site governance for GMP document control, records management, learning management, and training compliance within a large sterile injectable pharmaceutical manufacturing operation. The Manager ensures controlled documents and training systems remain compliant, inspection-ready, accurate, traceable, and effective throughout their lifecycle. This position suits a leader who can build a high-performing compliance team and drive sustainable improvements.
Responsibilities
Lead, coach, and develop the Document Control and Training Compliance team; establish objectives aligned with site Quality and business priorities and foster a culture of quality, accountability, teamwork, and continuous improvement
Act as site process/system owner for the electronic document management system (eDMS) and learning management system (LMS), including governance, access, workflows, business processes, data integrity, and sustained compliance
Own procedures, standards, metrics, and governance for controlled documents, GMP records, training administration, curricula, and qualification records
Partner cross-functionally to identify compliance risks, resolve systemic issues, implement CAPAs and change controls, and improve Quality Management System effectiveness
Oversee the complete lifecycle of controlled GMP documents, including SOPs, work instructions, forms, specifications, protocols, master batch records and other site-controlled content: authoring, review, approval, issuance, effective-date management, revision, periodic review, obsolescence, archival and retrieval
Ensure document workflows meet cGMP, Good Documentation Practices (GDP), corporate Quality standards, site procedures, and applicable regulatory requirements
Maintain robust version control, access control, traceability, reconciliation, and archival practices for paper and electronic GMP records
Own or oversee periodic review programs and ensure documents are reviewed, revised, retired, and made effective within established timelines
Manage GMP record retention, archive, retrieval, and destruction processes in accordance with approved retention requirements
Drive continuous improvement and standardization of document-control workflows to reduce cycle time, backlog, errors, and compliance risk
Lead the site training compliance program and maintain the LMS in a validated and compliant state in accordance with regulations, corporate requirements, and site procedures
Oversee training lifecycle activities including course creation, assignment, effective-date coordination, training verification, curricula creation and maintenance, qualification status, inactivation, and removal of obsolete training
Ensure training requirements are role-based, current, and aligned with approved procedures and job responsibilities; monitor completion and escalation of overdue or at-risk training
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Provide governance for GMP onboarding and new-hire training and ensure appropriate integration with functional and aseptic/sterile manufacturing qualification programs
Partner with functional SMEs to improve training effectiveness, instructional design, curricula architecture, and training-change impact assessments
Analyze training compliance data and trends to identify gaps, recurring issues, and opportunities to improve learning effectiveness and inspection readiness
Serve as the primary Quality Systems point of contact for document-control and training inquiries during regulatory inspections, corporate audits, and client audits; retrieve evidence promptly and ensure responses are accurate and complete
Develop and report KPIs for document lifecycle performance, periodic reviews, training completion, overdue training, curricula health, records management, and related compliance indicators for Quality Review and site governance forums
Ensure audit and inspection observations related to documentation or training are investigated, remediated, and sustained through effective corrective and preventive actions
Maintain continuous inspection readiness and promote behaviors consistent with cGMP, GDP, data integrity, and a strong site Quality culture
Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Quality Assurance, or related field
Master’s degree preferred
Minimum 6 years of experience in pharmaceutical or biopharmaceutical manufacturing, Quality Systems, compliance, document control, or GMP training, with at least 3 years in a leadership or people-management role
Experience supporting a large, complex GMP manufacturing site; sterile injectable, aseptic processing, biologics, or other highly regulated manufacturing experience strongly preferred
Demonstrated experience managing GMP document lifecycle processes and electronic document management systems (eDMS)
Demonstrated experience with LMS administration, training compliance, curricula management, or GMP learning systems
Experience supporting regulatory inspections and customer/client audits and providing rapid, accurate documentation and training evidence
Working knowledge of applicable cGMP requirements, including FDA 21 CFR Parts 210/211, Good Documentation Practices, data integrity principles, and pharmaceutical Quality Systems
Familiarity with ICH Q10 preferred
Experience with systems such as Veeva, MasterControl, TrackWise, SuccessFactors, ComplianceWire, or similar Quality/document/training platforms is preferred
Quality, Lean, Six Sigma, training, or instructional-design certification is an asset
Strong knowledge of cGMP, GDP, controlled-document practices, records management, training compliance, and Quality Systems governance
Ability to translate regulatory and corporate requirements into practical, sustainable site processes and controls
Excellent leadership, coaching, change-management, and team-development capabilities
Advanced organizational, record-keeping, analytical, and problem-solving skills with exceptional attention to detail and accuracy
Ability to manage competing priorities, high transaction volumes, and time-sensitive commitments in a fast-paced regulated manufacturing environment
Strong written, verbal, presentation, and interpersonal communication skills; able to interact effectively with operators, technical SMEs, site leadership, customers, auditors, and regulatory inspectors
Proficiency with electronic Quality systems, databases, reporting tools, and Microsoft Office applications
Ability to lead cross-functional projects and influence without direct authority while maintaining a strong customer-service and compliance mindset
Important Details
Schedule: Standard (Monday-Friday)
About the Company
Thermo Fisher Scientific provides global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
