Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
DESCRIPTION:
How Will You Make an Impact
The Manager, QA Document Control & Training Compliance provides site leadership and governance for GMP document control, records management, learning management, and training compliance across a large sterile injectable pharmaceutical manufacturing operation. The role ensures controlled documents and training systems remain compliant, inspection-ready, accurate, traceable, and effective throughout their lifecycle.
This leader serves as the site system owner and subject-matter expert for document and learning management processes, builds a high-performing compliance team, partners with Manufacturing, Quality Control, Engineering, Technical Operations and other functions, and drives sustainable improvements that support aseptic manufacturing, data integrity, operational readiness, and timely delivery to customers and patients.
A Day in the Life
Leadership & Quality Systems Governance
- 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.
Document Control & Records Management
- 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.
Training Compliance & Learning Management
- 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.
- 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.
Inspection Readiness, Metrics & Continuous Improvement
- 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.
Education
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Quality Assurance, or related field required. (Master’s preferred).
Experience
- 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.
Knowledge, Skills, Abilities
- 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.
Physical Requirements/Work Environment
Position requires ordinary ambulatory skills and physical coordination sufficient to move throughout office and manufacturing areas and to sit, stand, walk, reach, bend, stoop, kneel, and crouch periodically. May enter controlled manufacturing and cleanroom areas and must be able to comply with site gowning, hygiene, PPE, and safety requirements, including restrictions applicable to sterile manufacturing areas. Ability to use a computer, keyboard, and monitor and review electronic and paper records for prolonged periods. May occasionally lift and move light to medium materials in accordance with site requirements.
