Manager/Sr. Manager, CTO Quality Management & Operations

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 DESCRIPTIONThe 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 and Shanbally 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 r