Technical Manager, QA Operations

Description

About Technical Operations

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.

• Provide oversight of GMP Service Providers and Vendors used by BioMarin at the Novato site.
• Review and approve Service Providers and Service Owner questionnaires.
• Determine if Service Providers and Novato Vendors require Quality Technical Agreements (QTAs)
• Establish and approve QTAs with service owners and providers.
• Update and maintain the GMP Service Provider List in VeevaDocs.
• Maintain and archive quality records and documentation.
• Ensure training for all personnel involved in GMP services.
• Conduct regular assessments of service providers and quality processes.
• Perform gap assessments to evaluate current processes.
• Support Deviation, CAPA, Change Control, Laboratory Investigation and QC Excursions Business process managers with daily, monthly and quarterly activities.
• Support the reduction of record backlogs to improve efficiency.
• Monitor and analyze quality performance metrics to identify areas for improvement.
• Be part of process improvement initiatives to enhance quality systems and processes.
• Help users with questions on Quality Systems Processes and provide guidance.
• Prepare, share, and present Quality Metrics to stakeholders.
• Work with cross-functional teams to meet company objectives and ensure alignment.
• Ensure compliance with regulatory requirements and industry standards.
• Other duties as assigned.

• Minimum of 5 years within the biotechnology or pharmaceutical industry.
• Strong knowledge of quality management systems 
• Extensive knowledge of GMP, FDA, EMA, and other regulatory requirements.
• Excellent written and verbal communication and interpersonal skills
• Must display strong analytical and critical thinking skills
• Demonstrated influencing, interpersonal and teamwork 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.
  
   

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

• This is a remote position with a requirement for onsite presence at least one week per quarter.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.