Senior Director, Global Quality Assurance
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Senior Director of Global Quality Assurance supports 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.
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 TOPS internal quality system procedures, mitigation of identified compliance and quality risks throughout product life cycle from development through commercialization for the products manufactured at BioMarin.
Reporting to the VP, Global Quality Operations, the Senior Director of Global Quality Assurance is responsible for the Global Quality Management System, Quality Risk Management (QRM), Clinical Quality Operations and Oversight, Digital Data Quality Oversight, and Supplier Quality Management. This position involves working closely with partners across TOPS (Technical Development, Engineering, Manufacturing Operations, MSAT, Supply Chain) as well as groups outside of TOPs (Regulatory, Compliance, and Commercial) and will be a member of the Global Quality Leadership Team (QLT).
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 BioMarin Manufacturing network. The leader must possess leadership qualities and technical expertise in the areas of responsibility.
- 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.
- 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.
- Mature the Quality Risk Management (QRM) program in TOPs. Collaborate with key stakeholders in TOPs in QRM knowledge management, definition of roles and responsibilities and overall integration of QRM in TOPs culture.
- 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 BioMarin
- Provide leadership for data integrity initiatives and digital technology roadmap implementation
- Establish new ways to improve the BioMarin 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.
- 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
- 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.
PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.