Manager, QA
BioMarin PharmaceuticalNovato, California
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Job Description
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.
Summary:
This position reports to the Director, Novato Site QA Operations & Lot Release. This position leads the business automation projects and the Quality oversight of facility-agnostic change controls and projects originating from the Novato site. This position is also the Novato QA liaison to the Quality Strategic Partner Lead for the BioMarin-Sanofi partnership.
Responsibilities:
- QA oversight
- Provide QA oversight for facility-agnostic change controls and projects originating from Novato manufacturing sites
- Functions as an alternate QA Frontline manager to represent Quality in Process Team, provide QA Frontline oversight, and support Manufacturing Operations on the floor
- BioMarin-Sanofi partnership management
- Act as Novato QA main point of contact for queries coming from Sanofi
- Perform Sanofi partner notifications for deviation, QC excursion, and change control QMS records
- Upload QMS record reports to SharePoint
- Complete Sanofi DS lot schematic, documentation checklist, CMC assessment form for Aldurazyme lots
- Lead business automation projects to support advancing Novato Quality’s technology capabilities in day-to-day operations
- Maintain current knowledge of industry standards and regulatory requirements for products manufactured by BioMarin
- Represent Novato Site Quality in multi-departmental meetings & project teams
- Assist as needed in audits and inspections
- Other duties as assigned
Experience and Other Qualifications:
- BS/BA in a scientific discipline or related field and 8-10 years' experience in a biologics manufacturing environment
- 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.
- 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.
- Build strong, effective working teams; build relationships to share best practices, and collaboratively solve problems.
SHIFT DETAILS
Regular day hours 8am-5pm
ONSITE, REMOTE, OR FLEXIBLE
This role supports a hybrid working model with a minimum of 2 days onsite in Novato each week, and flexibility for more frequent onsite presence depending on projects and business support needs.
TRAVEL REQUIRED
Regular travel is not a requirement of the role, though some travel for conferences and global alignment initiatives will present opportunities for travel.
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.