Senior Manager, Quality Systems

Brief team/department description:

Job Type: Full-Time

The Manager, Documentation Management plays a leadership role in sustaining a robust and inspection-ready Quality Management System (QMS) within a regulated pharmaceutical environment. This position is responsible for ensuring the integrity, compliance, and continuous improvement of controlled documentation and electronic quality systems, with a strong focus on adherence to GxP and regulatory requirements such as 21 CFR Part 11 and EU Annex 11.

Principle Responsibilities:

• Lead the development, implementation, and continuous improvement of a compliant, inspection-ready Quality Management System (QMS) in accordance with industry regulations and internal standards.
• Oversee the validation, integrity, and lifecycle compliance of electronic quality systems, including enterprise-wide document management platforms.
• Manage the Documentation Management System, ensuring efficient control, authorship, review, approval, and periodic revision of all controlled documents (e.g., SOPs, policies, work instructions) in alignment with lifecycle and regulatory requirements.
• Direct document lifecycle activities, ensuring timely execution and alignment with GxP standards and applicable regulatory frameworks.
• Develop and lead GxP training strategies and programs to ensure that functional teams maintain a high level of quality awareness and compliance readiness.
• Drive cross-functional continuous improvement initiatives aimed at optimizing quality system performance and documentation processes.
• Lead the planning, oversight, and execution of the Computer System Validation (CSV) program to ensure compliance with 21 CFR Part 11, EU Annex 11, and internal validation requirements.
• Serve as a point of contact for internal and external audits and regulatory inspections, ensuring documentation systems are readily accessible, compliant, and defensible.

Qualifications and Education Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Quality, or a related field (advanced degree preferred).
• 5–7 years of progressive experience in documentation management, quality assurance, or regulatory compliance within the pharmaceutical or biotech industry.
• Strong working knowledge of GxP principles, 21 CFR Part 11, EU Annex 11, and other applicable regulatory standards.
• Proven experience managing electronic Document Management Systems and executing Computer System Validation (CSV) activities.
• Demonstrated leadership, project management, and cross-functional collaboration skills.
• Exceptional attention to detail, organizational capability, and ability to manage multiple priorities in a fast-paced, regulated environment.

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