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.
