Senior Director of Quality Assurance Profile:
The Senior Director of Global Quality Assurance will support the Quality Leadership Team to promote the pursuit of world class quality standards and will embed a quality culture and mindset in all organizational activities. They will report to the VP, Global Quality Operations.
The Senior Director of Global Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. This position will provide strategic direction and guidance for the Global Quality Assurance functions to assure end-to-end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements. The position is also responsible for ensuring that Quality operates in compliance within the internal quality system procedures, mitigation of identified compliance and quality risks throughout product life cycle from development through commercialization for the products manufactured at the company.
This position requires a broad range of knowledge and experience with quality assurance and system, regulatory compliance and understanding of the international regulatory landscape for the manufacturing of API, DS and DP across the company network.
Senior Director of Quality Assurance Key Activities
The successful Senior Director of Quality Assurance will be responsible for the following tasks:
- Responsible for the Global Quality Management System, Quality Risk Management (QRM), Clinical Quality Operations and Oversight, Digital Data Quality Oversight, and Supplier Quality Management.
- Provide leadership, vision and direction to the Global Quality Assurance Organization to ensure it contributes to becoming a World Class Quality Organization.
- Establish and maintain risk-based and fit-for-purpose global quality management system. Develop, implement, and communicate quality policies, standards, and procedures to ensure consistency across the network and alignment with global processes and Quality objectives.
- Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures.
- Provide leadership and direction regarding supplier quality management strategy and systems to ensure the suppliers meet appropriate regulatory requirements and standards set by the company.
- Provide leadership for data integrity initiatives and digital technology roadmap implementation.
- Establish new ways to improve the company quality management system and explore innovative approaches to facilitate efficiency in the day-to-day operations and quality improvement projects
- Lead 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 Quality Management System Process Workflows.
- Provide leadership in global issue management including product complaint and product recall process.
- Establish and maintain process and systems for product launch readiness in compliance with marketing authorizations, established specifications management, and quality approval requirements in compliance with regulations and other applicable standards.
- Lead and mentor a team of Quality professionals to navigate and lead in a matrix organization.
- Develop and manage department budgets and long-range plans for the team.
Senior Director of Quality Assurance Specification
The following will be required of the Senior Director of Quality Assurance:
- 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry.
- In-depth understanding and application of cGMP principles, concepts, practices, and standards.
- 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.
- 10+ years of prior management level experience with demonstrated ability to develop and mentor staff.
- Excellent interpersonal and communication skills.
- Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
- Demonstrated ability to partner with other functional group to achieve business objectives.
Senior Director of Quality Assurance Personal Skills and Qualifications
The successful Senior Director of Quality Assurance will possess the following:
- BA/BS/Ph.D in life sciences or related field.
- Advanced degree desirable, but not required.
- Ability to travel up to 20% as required.
- This role is hybrid and requires minimum two days per week onsite in Novato, CA.
To Apply for the position of Senior Director of Quality Assurance, or to find out what other opportunities we can offer in the life sciences sector, please either use the form on the right or contact us on +44 (0) 1252 938 100 or ContactUs@centrelineresourcing.com at Centreline Resourcing. You can also find our currently advertised jobs at https://centrelineresourcing.com/jobs/ or check out our LinkedIn page at https://www.linkedin.com/company/centreline-resourcing/
