Executive Director, Global Quality Assurance

Who We Are

For nearly three 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 significant 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 Culture

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. 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 innovative 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.

JOB SUMMARY:

The Executive Director of Global Quality Assurance will provide strategic quality systems and quality compliance leadership in the GMP, GCP and GDP areas within scope and will be responsible for the integrated Quality Management System (QMS) across TOPS, including Technical Development, Global Operations & Supply, in support of the product lifecycle. This position will also be accountable for the performance of the Global Quality Assurance processes providing strategic direction and guidance to the reporting functions, and assuring end-to-end harmonization of quality processes, where needed. The person in this role is also responsible for providing QMS governance and controls, to ensure the global organization operates in compliance with our quality system and mitigates identified compliance and quality risks throughout the product life cycle for the products developed and manufactured at or on behalf of BioMarin.

The Executive Director of Global Quality Assurance plays an integral role in fostering a culture of quality, through the effective implementation of the QMS, ensuring that effectiveness and efficiency, from a performance perspective, is managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations, and in keeping with external industry trends inclusive of Corporate GXP Compliance audits, Health Authority inspections and KPI measurements.

Reporting to the SVP, Chief Quality Officer, the Executive Director of Global Quality Assurance is responsible for the Global Quality Management System and oversight, Quality Risk Management (QRM), Annual Product Review, Global Document Management, Global Quality Issue Management (GIM), Product Complaints, Product Recall, Data Integrity Quality Oversight, and Supplier Quality Management. This position involves working closely with all quality functions and partners across TOPS (Technical Development, Engineering, Manufacturing Operations, MSAT, Supply Chain) as well as groups outside of TOPS (Regulatory Affairs, GXP 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, quality systems and regulatory compliance, understanding the international regulatory landscape for the manufacturing, packaging and distribution of API, DS and DP for all modalities within the BioMarin TOPS network. The leader must possess executive leadership qualities, business acumen and technical expertise in the areas of responsibility.

RESPONSIBILITIES:

• 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 (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.
• 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
• Develop, implement, and communicate quality policies, standards, and procedures to ensure consistency across the network and alignment with global processes.
• 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.
• 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
• 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)
• Provide leadership for data integrity initiatives and Quality digital technology roadmap implementation
• Provide leadership in global issue management (GIM) including product complaints and product recall process management and reporting.
• 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.
• Explore innovative approaches to facilitate efficiency in the day-to-day operations and quality improvement projects
• 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.

EXPERIENCE:

• 15+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
• Extensive knowledge and experience in GMP, GCP and GDP global regulations, 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
• 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
• Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management
• In-depth experience in managing teams, and in providing coaching, development and mentoring to employees
• Excellent interpersonal and communication skills and 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

EDUCATION:

• BA/BS/Ph. D in life sciences or related field
• Advanced degree desirable, but not required

OTHER:

• Ability to travel up to 20% as required
• Strong preference for candidates local to Novato, CA. But open to a fully remote arrangement.

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.

In the U.S., the salary range for this position is $ 232,000 to $ 348,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.