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Executive Director, Global Quality Assurance
Company | BioSpace |
Address | Novato, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Internet News |
Expires | 2023-08-15 |
Posted at | 9 months ago |
Who We Are
- Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting.
- Establish and maintain risk-based and fit-for-purpose global quality management (QMS) system ensuring effective implementation, which is managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations effectively and efficiently.
- Provide leadership and direction regarding supplier quality management strategy and systems to ensure the suppliers meet appropriate regulatory requirements and standards set by BioMarin (does not include CMO’s/CDMO/s or Contract Labs)
- Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
- Oversees and leads quality and compliance risk management initiatives to minimize risk and potential impact of quality and/or non-compliance events
- Mature the Quality Risk Management (QRM) program. Collaborate with key stakeholders within TOPS in QRM knowledge management, definition of roles and responsibilities and overall integration of QRM.
- Lead Quality Management Review activities and oversee trending of key GMP quality management system performance metrics. Report and escalate compliance issues to management.
- Collaborate with global and site stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows
- Explore innovative approaches to facilitate efficiency in the day-to-day operations and quality improvement projects
- Provide leadership for data integrity initiatives and Quality digital technology roadmap implementation
- Develop, implement, and communicate quality policies, standards, and procedures to ensure consistency across the network and alignment with global processes.
- Establish and maintain process and systems in support to product launch readiness compliant with marketing authorizations, established specifications management, and quality approval requirements in compliance with regulations and other applicable standards.
- Develop and manage department budgets and long-range plans for the team.
- Lead and mentor a team of Quality professionals to navigate and lead in a matrix organization.
- Provide leadership, vision, and direction to the Global Quality Assurance Organization to ensure it contributes to becoming a World Class Quality Organization and to achieve the TOPS Strategy and Corporate objectives.
- Demonstrated ability to partner with other functional group to achieve business objectives
- Experience in Computer System Validation, Analytical Methods development/transfer, Quality Systems, Product Quality complaint, combination Products/Device Quality desirable
- 10+ years of prior management level experience with demonstrated ability to develop and mentor staff, and have managed a global organization involving diverse cultures and employees
- Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
- 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
- In-depth experience in managing teams, and in providing coaching, development and mentoring to employees
- Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge in international regulatory landscape preferred
- Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management
- Extensive knowledge and experience in GMP, GCP and GDP global regulations, principles, concepts, practices, and standards.
- Advanced degree desirable, but not required
- BA/BS/Ph. D in life sciences or related field
- Strong preference for candidates local to Novato, CA. But open to a fully remote arrangement.
- Ability to travel up to 20% as required
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