Senior Corporate Quality Risk Management Supervisor

We are seeking an experienced Corporate Senior Quality Risk Management Supervisor to lead risk-based quality oversight across pharmaceutical manufacturing sites, projects, and facility upgrades. The successful candidate will have proven experience in a multinational, EU GMP, or US FDA-regulated pharmaceutical manufacturing organization, with strong expertise in Quality Risk Management, Compliance, qualification, validation, and project execution. Key Responsibilities: • Design, maintain and ensure implementation of harmonized corporate policies and tools related to Quality risk management • Ensure alignment with ICH Q9/Q9(R1), ISPE, EU GMP, US FDA expectations, Annex 1, contamination control, data integrity, and GxP computerized-system requirements. • Design and implement a certification process for QRM champions across corporate functions and sites • Assess all Quality management systems and ensure that Risk management is embedded with the process and systems such as non-conformance, change management, internal audits, investigations, supplier qualification etc. • Ensure that all major systems are assessed for any potential risk of failures and the appropriate risk mitigation actions are identified, implemented and effective. • Leading QRM activities for major projects such as new facilities, and new lines • Develop and execute remediation plans with clear milestones, accountable owners, risk controls, effectiveness checks, and sustainable closure. • Support quality transformation programs focused on: • Simplification and harmonization of global quality processes. • Strengthening quality culture and management ownership. • Digital QMS, risk-based workflows, data analytics, and performance dashboards. • Improved right-first-time performance, inspection readiness, and operational resilience • Facilitate and review risk-based assessments. • Support risk assessments for deviations, CAPA, change controls, OOS/OOT investigations, complaints, recurring events, and inspection readiness. • Promote responsible adoption of digital QRM/eQMS tools, analytics and dashboards, AI-assisted risk identification, digital validation, automation, smart manufacturing, and sustainable facility design, with appropriate governance, validation, human oversight, and data-integrity controls. Required Experience and Qualifications: • Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Microbiology, or a related discipline. • Typically, +12 years of relevant pharmaceutical experience in Quality, Validation, Engineering, Technical Operations, or GMP projects. • Proven experience leading and governance of QRM activities within a reputable pharmaceutical manufacturing organization, preferably a multinational, EU GMP, or US FDA-regulated company. • Demonstrated experience with new facilities, major facility upgrades, new production or packaging lines, critical utilities, and technology transfer projects. • Strong working knowledge of GMP, pharmaceutical quality systems, validation, contamination control, data integrity, and risk-based decision-making. • Experience in sterile, aseptic, biologics, non-sterile, high potent & other highly regulated manufacturing is highly desirable. • Excellent facilitation, technical writing, stakeholder-management, influencing, and cross-site leadership skills. Show more Show less

Bachelor’s degree in Pharmaceutical Sciences, Engineering, Chemistry, Microbiology, or a related discipline. Typically, +12 years of relevant pharmaceutical experience in Quality, Validation, Engineering, Technical Operations, or GMP projects. Proven experience leading and governance of QRM activities within a reputable pharmaceutical manufacturing organization, preferably a multinational, EU GMP, or US FDA-regulated company. Demonstrated experience with new facilities, major facility upgrades, new production or packaging lines, critical utilities, and technology transfer projects. Strong working knowledge of GMP, pharmaceutical quality systems, validation, contamination control, data integrity, and risk-based decision-making. Experience in sterile, aseptic, biologics, non-sterile, high potent & other highly regulated manufacturing is highly desirable. Excellent facilitation, technical writing, stakeholder-management, influencing, and cross-site leadership skills.

Design, maintain and ensure implementation of harmonized corporate policies and tools related to Quality risk management. Ensure alignment with ICH Q9/Q9(R1), ISPE, EU GMP, US FDA expectations, Annex 1, contamination control, data integrity, and GxP computerized-system requirements. Design and implement a certification process for QRM champions across corporate functions and sites. Assess all Quality management systems and ensure that Risk management is embedded with the process and systems such as non-conformance, change management, internal audits, investigations, supplier qualification etc. Ensure that all major systems are assessed for any potential risk of failures and the appropriate risk mitigation actions are identified, implemented and effective. Leading QRM activities for major projects such as new facilities, and new lines. Develop and execute remediation plans with clear milestones, accountable owners, risk controls, effectiveness checks, and sustainable closure. Support quality transformation programs focused on: Simplification and harmonization of global quality processes. Strengthening quality culture and management ownership. Digital QMS, risk-based workflows, data analytics, and performance dashboards. Improved right-first-time performance, inspection readiness, and operational resilience. Facilitate and review risk-based assessments. Support risk assessments for deviations, CAPA, change controls, OOS/OOT investigations, complaints, recurring events, and inspection readiness. Promote responsible adoption of digital QRM/eQMS tools, analytics and dashboards, AI-assisted risk identification, digital validation, automation, smart manufacturing, and sustainable facility design, with appropriate governance, validation, human oversight, and data-integrity controls.