Associate Director, Quality Validation

Who We Are

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.

SUMMARY The Associate Director, Quality Validation is a highly motivated technically knowledgeable leader with proven abilities to lead quality validation and engineering and promote continuous improvement and efficiencies through the application of lean strategies that are compliant with regulations and industry standards.

The Head of Quality Validation is part of the Novato Quality Leadership team (NQLT), reporting to the Site Head of Quality.

Our company was founded in Novato, California nearly 30 years ago. This leader will provide strategic direction for the Novato Site Validation, establishes clear expectations, goals, and metrics and is accountable for the quality oversight of all validation activities at the Novato site.

The scope of the validation oversight includes facility, utility, equipment, automation qualification / validation activities and process validation activities supporting the Novato site manufacturing and testing.

The position is an integral part of Novato operations and a key partner to Engineering and Facility Services by providing guidance and quality oversight for the design and / or changes to facility, utility, equipment, automation.

This leader will hire, develop, and retain a high performing team, highly skilled in quality and compliance, driving excellence in Quality and productivity;

effectively implement new quality technologies and create an environment where our people will be engaged, grow, and thrive displaying a strong quality culture.

This position requires a broad range of knowledge and experience with biologic processes, quality engineering and validation and understanding of the international regulatory landscape. Key Responsibilities

• Direct validation process improvements and goals using current regulations and demonstrated best practices. Continuously monitor industry trends and changes in regulations.
• Provide direction and leadership to the quality validation department, to the site and globally in establishing validation strategies based on industry best practices and regulatory expectations.
• Develop and support departmental strategic goals to assure the highest quality standards and regulatory compliance.
• Establish appropriate metrics to monitor the various validation activities that drive efficiencies.
• Responsible for providing quality assurance oversight for all validation related activities.
• Responsible for the integration of risk management program in validation activities.
• Establish effective partnership with the following key cross-functional groups to ensure a streamlined and effective validation program :
• Global Quality Assurance
• Novato Facilities and Engineering
• TDS (MSAT)
• QC (Quality Control)
• IT (Information Technology)
• Quality Operations
• Ensure the creation, management, review, and quality approval of all aspects of required validation documentation such as master plans, project plans, URS, FRS (Functional Requirements Specification), impact assessments / risk assessments, revalidation plans, design documents, P&IDs, protocols / reports etc.
• Ensure that facilities, laboratory equipment, utility systems and process equipment are maintained in qualified / validated state and that reports are written accurately and timely.
• Maintain and manage departmental annual budget for internal and external resources and expenses for the Novato Site QA Validation Department.
• Responsible for all QA Engineering activities for the Novato, CA Site.
• Provide technical support in regulatory filings as required.
• Collaborate with cross-functional teams to ensure quality considerations are integrated into product development and manufacturing processes.
• Review and approve validation protocols and reports and Quality Management System (QMS) as needed.
• Manage Quality Management Systems and processes related to validation activities.
• Ensure timely completion of validation activities and projects.
• Author annual product quality review and ensure validation protocols and processes follow global regulatory requirements.
• Present overviews and defend site validation programs to regulatory and other agencies, as necessary.
• Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives.

Experience

• 10+ years of experience with Biotechnology, Pharmaceutical, Medical Device or Other highly regulated industry.
• 7+ years of experience in Validation or Quality Engineering.
• 5+ years of prior management level experience with demonstrated ability to develop and mentor staff.
• Strong critical thinking skills.
• Demonstrated influencing, interpersonal and teamwork skills.
• Strong collaboration skills
• Demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes.
• Experience in Lean best practices and cGMP highly desired.
• Demonstrated ability to work independently, proactively identifying opportunities and taking actions.
• Excellent organizational agility that demonstrates how to get results while strengthening internal and external relationships with minimal resources.
• Consistent demonstration of managerial courage to make timely decisions without complete data to ensure quality product to patients.
• Highly skilled in the ability to work with ambiguity and complexity and can continuously modify options and solutions across all levels of the organization.
• Ability to influence diverse stakeholders and drive accountability and decision-making cross-functionally.
• Ability to work effectively with stakeholders.
• Results oriented; effectively manages multiple projects efficiently.
• Excellent written and verbal skills; ability to communicate effectively with all levels of the organization; effective public speaker.
• Build strong, effective working teams; build relationships to share best practices, and collaboratively solve problems.
• In-depth understanding and application of cGMP principles, concepts, practices, and standards.
• In-depth understanding of GMP compliance required.
• Active participation in industry forums related to validation is highly desired.

Education :

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

Other : Ability to travel up to 10%. Role is hybrid workstyle, which BioMarin defines between 2-4 days per week onsite in Novato depending on business need.

Equal Opportunity Employer / Veterans / Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.