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Associate Director, Quality Compliance
Novato, CA
Job Description
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.
Associate Director, Novato Quality Compliance
SUMMARY
The Head of Novato Quality Compliance is part of the Novato Quality Leadership team (NQLT), reporting to the Site Head of Quality and is accountable for all GMP compliance activities for the Novato Site and network services that are managed out of the Novato site.
The Associate Director of compliance is a pivotal role in setting the GMP compliance tone for the Novato Site. The incumbent leads the site in compliance and inspection readiness activities by designing, enhancing, and implementing processes to ensure compliance with regulations, health authority expectations, maintain a constant inspection ready state and ultimately driving to maintain our right to operate.
The incumbent will hire, train, develop and retain a highly skilled quality and compliance workforce, drive excellence, and productivity, effectively implement efficient systems and tools and foster an environment where our people will be engaged, grow, and thrive displaying a strong quality culture.
This position requires a high level of influencing, collaboration, leadership courage as well as a broad range of knowledge and experience with biologic and chemical processes, in-depth knowledge of GMP compliance across various drug manufacturing stages as well as managing and interacting with health authorities during inspections.
KEY RESPONSIBILITIES
-Establish and maintain end-to-end health authority inspection readiness processes for the Novato Site
-Establish and maintain end-to-end Novato self-inspection program to maintain constant readiness.
-Establish and maintain compliance and inspection risk log management, escalation and reporting process.
-Lead/host health authority inspections, partner, and internal audits.
-Oversight and execution of health authority inspections, GMP certifications and renewal.
-Establish/enhance routine Manufacturing Quality Review process for the site to drive performance improvements and increase compliance. Lead the quality review process to ensure site regulatory compliance and to identify opportunities for continuous improvement of products, processes, and the quality system.
-Establish and maintain Novato site APR process.
-Manage health authority GMP certification and renewal activities.
-Review and approval all compliance related documentations including Lot Release Protocol Report (LRP), GMP Statements and other required GMP certifications.
-Responsible for the maintenance and update of Novato Site Master File
-Responsible for the oversight and management of Discrepancy and CAPA systems for Novato Site
-Establish and maintain cross-site/cross-functional network to benchmark and drive alignment as needed.
-Establish and maintain effective partnerships with key cross-functional stakeholders including, but not limited to the following:
-Manufacturing
-Supply Chain
-MSAT
-Technical Development
-Regulatory
-Quality Site partnerships and Global Quality
-Partner and align with compliance heads across the quality organization to drive alignment and drive compliance related initiatives.
-Oversight of Novato Site GMP training program, training material content generation and requirements.
-Knowledgeable in current industry compliance and inspection trends.
-Interpret and apply applicable 21CFR, USP, EP. JP, and ICH regulatory guidelines and directives.
-Lead and develop high performing team.
-Maintain and manage cost center budget.
Experience:
-10+ years of experience with Biotechnology, Pharmaceutical, Medical Device or Other highly regulated industry
-5+ years of prior management level experience with demonstrated ability to develop and mentor staff.
-Strong influencing, interpersonal and teamwork skills.
-Strong collaboration skills and demonstrated ability to lead change and identify opportunities that have resulted in positive business outcomes.
-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
-Experience in internal auditing is desirable.
-Prior experience with leading leading/hosting regulatory inspections, managing inspection readiness programs, self-audit programs and inspection response process required.
-Regulatory, Quality, Compliance, or a combination of technical experience such as analytical development/manufacturing sciences and Quality/Regulatory.
In-depth understanding of GMP compliance required.
Education:
-BA/BS in life sciences or related field
-Advance degree desirable, but not required.
Other:
-Ability to travel up to 30%
-This role requires on site and 5 days/week.
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.
In the U.S., the salary range for this position is $ 136,700 to $ 205,100 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.
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
Job Summary
Company
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
10+ years
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