Quality Manager

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Implement enterprise validation initiatives aimed at enhancing consistency and harmonization across various Business Groups.

• Act as the Business Process Owner for enterprise validation platforms, fostering adoption, optimization, and ongoing improvement.

• Enhance validation compliance, inspection readiness, and governance through the establishment of standardized validation practices.

• Contribute to enterprise capability development via the Global Validation Council, Validation Academy, and Communities of Practice.

• Create reusable validation guidance, templates, and best practices to boost efficiency and minimize redundancy.

• Generate metrics and reporting to enhance enterprise visibility into validation performance, risks, and opportunities.

• Function as the Business Process Owner for Kneat and ALM.

• Provide oversight for Corporate Quality governance concerning the Global IT Computerized Systems Validation Program.

• Execute and continually enhance enterprise validation governance, standards, guidance, and best practices set by Corporate Quality.

• Carry out validation harmonization initiatives across Business Groups while accommodating business-specific requirements.

• Collaborate with Quality & Regulatory Affairs, IT, Engineering, Manufacturing, Regulatory Affairs, and Business Groups to advance enterprise validation priorities.

• Offer validation subject matter expertise for enterprise digital initiatives and emerging technologies, including AI-enabled quality solutions.

• Support the Global Validation Council as an enterprise Community of Practice, Center of Excellence, and Validation Academy.

• Oversee the development of enterprise validation guidance, toolkits, standards, and knowledge-sharing resources.

• Facilitate Communities of Practice and enterprise working groups.

• Organize enterprise training, knowledge transfer, and capability-building initiatives.

⛳️ Requirements

• Over 8 years of progressive experience in validation within FDA, ISO, or other regulated settings.

• Proficiency across various validation disciplines, including CSV, Equipment Qualification, Facility & Utility Qualification, Commissioning & Qualification (C&Q), Process Validation, Cleaning Validation, Analytical Method Validation, Analytical Instrument Qualification, and validation lifecycle management.

• Experience in implementing validation governance, enterprise standards, best practices, or quality system enhancements.

• Background as a BPO, system owner, or process owner for enterprise quality or validation systems.

• Proven experience supporting regulatory inspections and addressing validation-related observations.

• Experience in a global, highly matrixed organization serving multiple Business Groups.

• Demonstrated success in leading enterprise initiatives and influencing cross-functional stakeholders without direct reporting authority.

• Familiarity with Kneat, ALM, or similar enterprise validation platforms is preferred.

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Information Systems, Computer Science, or a related technical field is required.

• An advanced degree is preferred.

• Professional certifications such as ASQ, Lean Six Sigma, Certified Validation Professional (CVP), CSV, Quality, or Regulatory certifications are preferred.

• Expert knowledge of validation lifecycle principles across various validation disciplines.

• Strong understanding of ASTM E2500, GAMP® 5, ISPE guidance, Annex 11, 21 CFR Part 11, and other relevant GxP regulations.

• Proficient in governance, process management, and continuous improvement methodologies.

• Experience with enterprise validation platforms and emerging technologies, including AI-enabled software, automation, cloud platforms, and digital quality systems.

• Ability to execute enterprise validation strategy through governance, collaboration, stakeholder engagement, and business process ownership.

• Strong stakeholder management and influencing abilities, with a capacity to lead through collaboration rather than formal authority.

• Exceptional written, verbal, presentation, facilitation, and communication skills.

• Robust analytical, critical thinking, and problem-solving skills.

• Capability to translate complex validation concepts into actionable guidance, standards, training, and business solutions.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.