Manager, Document Control Quality Systems & Compliance

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

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

• Bachelors degree in Life Sciences Pharmacy Chemistry Quality Assurance or related field required. (Masters 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.