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Manager/Sr. Manager, CTO Quality Management & Operations

Employer
BioMarin Pharmaceutical Inc.
Location
Novato, California
Start date
May 20, 2024

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Job Details

The Manager/Sr. Manager, CTO Quality Management & Operations, reports to Associate Director, CTO Quality Management & Operations and is responsible for the oversight of Contract Testing Organizations (CTO’s) where the CTO performs testing of BioMarin Intermediates, Drug Substance/API and Drug Product.  The Manager/Sr. Manager, CTO Quality Management & Operations will oversee CTO performance including Method Transfers, Release testing, Quality oversight & will facilitate technical support. The role also plays a pivotal role in ensuring effective communication and streamlined processes within the organization, particularly in the context of outsourced QC testing.  The Manager/Sr. Manager, CTO Quality Management & Operations acts as a conduit, ensuring effective internal and external communication, efficient problem-solving, and continuous quality enhancement across the organization and with the partners. This position will work closely with and serve as a business partner to External Partners, Site Quality Control Functions (Novato, CA and Shanbally Ireland Operations), Quality Analytical Technologies, and TOPS Product Team. 

RESPONSIBILITIES
•    Oversee Quality performance and issues at the CTO ensuring resolution in a compliant manner. 
•    Lead the Quality oversight strategy for the CTO by assessing CTO health and adjusting Quality oversight as appropriate.
•    Partner cross-functionally to ensure Quality, QC and Supply needs are met by the CTO.
•    Develop plans to reduce risk level and improve performance in partnership with CTOs.
•    Project manage the transfer of Methods into a CTO liaising internally with SME’s cross functionally. 
•    Support in-country testing requirements including the set-up of in-country central labs as needed. 
•    Ensure Quality Review Meetings (QRM) with CTO are conducted as required.
•    Ensure QTAs are maintained and administered as required.
•    Work in partnership with BioMarin Global Compliance & Ethics (GCE) to schedule compliance audits and resolve any compliance gaps identified including from Health Authorities.
•    Ensure adherence to company policies/procedures, regulatory licenses or clinical trial applications, applicable Quality and Technical agreements, industry standards, and GMP regulations.
•    Lead and/or participate in Quality Risk Assessments for significant events such as changes, deviations, product complaints and compliance gaps.

 Supervision Received:
•    Works autonomously on the accomplishment of agreed upon goals and objectives.
•    Proactively identifies and reports discrepancies from normal practices or procedures to senior management, recommending and implementing plans for improvements. Expected area of competence:
•    Deal with complex issues using critical analysis and develops ethical, reasoned solutions to meet both business and regulatory requirements. 
•    Influence the organization by communicating quality issues and decisions, which impact the business.
•    Ensure adherence to company policies and procedures and applicable Quality and Technical Agreements
•    Active participation to company business growth objectives for quality alignment.

 Decision making:
•    Establish operational objectives within the team.
•    Be involved in developing, modifying, and executing company policies and procedures that affect quality control operations.
•    Work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
•    Ensure budget schedules and performance requirements are met. EDUCATION•    Must possess a Bachelor's degree in Sciences, biotechnology, chemistry, microbiology or equivalent
•    Advanced degree preferred. EXPERIENCE•    5 to 10+ years of experience within the quality function of the pharmaceutical health care industry or with regulatory agencies
•    Extensive knowledge and experience in pharmaceutical health care operations, quality control, quality assurance, and international regulations are essential. 
•    Proficient in cGMPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies; ISO 9001:2000 regulations. Salary Range:The advertised salary range for this position is set at the Manager level. If the candidate's experience justifies Sr. Manager level, the salary range and compensation components will be adjusted accordantly. 
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.

Company

BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. In 1997, the company was founded to make a big difference in small patient populations, focusing on giving much-needed attention to the underserved communities of those with rare diseases. BioMarin sought to help patients whose voices could not always be heard and treat conditions that were not always in mainstream medical conversations. Throughout its history, BioMarin has worked tirelessly to make a difference by pursuing bold science. The company’s first approved therapy was inspired by a father who refused to accept there was no therapy for his son’s rare diagnosis. That relentless pursuit to change the course of his son’s future through the power of science is at the core of who BioMarin is today.

Through the company’s expertise in genetics and molecular biology, BioMarin has developed eight first or best-in-class targeted therapies that address the root cause of the conditions it seeks to treat, helping to better the lives of those struggling with rare genetic disease. The company’s purposeful and scientifically precise team of physicians and scientists has honed each treatment modality to seek transformative therapies.

Now, BioMarin seeks to make an even greater impact by applying the same science-driven, patient-forward approach that propelled the last 25 plus years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Each drug candidate pursued is guided by a fundamental understanding of the genetics and underlying biology of the condition it will address. The company believes that applying its knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The more innovative solutions developed, the more lives BioMarin can impact.

Company info
Website
Location
California
United States

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