Head of Regional R&D Quality and Compliance
vor 4 Wochen
As the Head of Regional R&D Quality and Compliance, you will be responsible for leading the R&D Quality and Compliance organization in EMEA, ensuring that the R&D organization operates in compliance with company/division policies and procedures, as well as applicable regulatory requirements. You will provide strategic management oversight and leadership to the EMEAl R&D Quality and Compliance organization, implementing quality monitoring programs to proactively ensure compliance.
Key Responsibilities- Provide strategic management oversight and leadership to the EMEAl R&D Quality and Compliance organization.
- Implement quality monitoring programs to proactively ensure compliance.
- Ensure innovative compliance solutions are identified, when possible, to address project and process challenges.
- Ensure effective deployment of R&D Quality and Compliance resources to meet the current and future needs of the R&D organization.
- Provide ongoing mentoring, coaching, and development of R&D Quality and Compliance employees.
- Ensure employees are trained in procedures and systems associated with their assigned tasks.
- Perform administrative tasks associated with performance reviews, salary administration, and other personnel tasks.
- Responsible for the regional budget planning process and management of regional budgets.
- Recruits/hires qualified employees for the department and ensures employees have the education, experience, and tools to appropriately function as advisors of GMP, Good Documentation Practices, and other applicable requirements.
- Participate in the Regional R&D and the Regional Quality and Compliance Leadership Teams, providing R&D Quality and Compliance support to strategic discussions/decision making.
- Lead R&D Management Reviews and other compliance activities in the regions and escalate issues appropriately.
- Collaborate within and across regions and with Global Regulatory Compliance and Standards to evaluate compliance trends and ensure adequate action plans are developed, implemented, and evaluated for effectiveness.
- Interpret regulations to provide risk analysis guidance and make decisions about R&D GxP activities as they apply to products, processes, practices, and procedures.
- Responsible to be an ambassador for change to ensure compliant processes and systems are established and maintained to meet the changing regulatory environment.
- Provide strategic direction and leadership to drive continuous process improvements within R&D, and within Quality and Compliance, ensuring appropriate interpretation of company and regulatory policies and requirements.
- Provide R&D Quality and Compliance support for any inspection within region.
- Participate and/or manage business activities relating to Health Authority inspections/company audits, liaising with other Quality and Compliance organizations as appropriate.
- Master's degree in Pharmacy, Chemistry, Engineering, or related scientific field.
- 10+ years of related experience in a regulated industry.
- Good knowledge of GMP regulations in Pharmaceutical, Medical Device, and Cosmetic product classifications.
- Minimum of 10 years of Quality experience and 7 years of people management experience.
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