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Sr. Manager, Manufacturing Investigations

BioMarin Pharmaceutical Inc.
Novato, California
Start date
Sep 19, 2023

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Job Details

Job Title:  Sr. Manager, Novato Manufacturing Investigations

The Sr. Manager of Manufacturing Investigations is responsible for managing the performance of the critical compliance functions of investigations. This role manages a group that assures deviation record management is in a state of compliance with all BioMarin standards and current industry and regulatory standards.  The role also establishes the systems by which these compliance activities are executed in an organized and efficient manner.   

The role includes involvement in Deviations, CAPAs, Effectiveness Checks and Change Control. Investigations within the scope of this role are: 

  • Manufacturing Deviation Events (Moderate and Major)
  • Supply Chain Operations Deviation Events (Moderate and Major)
  • California Facilities and Engineering Deviation Events (Moderate and Major)  

The scope covers commercial products across various modalities.   

This position reports to the Head of Business Operations and is a member of the Business Operations Leadership Team.  The successful candidate ensures functional objectives are aligned with company goals and regulatory expectations. The role requires strong structured problem-solving skills, project management skills, and the ability to collaborate with a broad variety of cross-functional departments. 


Role Responsibilities

  • Provide directives and manage a team of direct reports to assure that Manufacturing investigations are in a state of compliance with all BioMarin standards and current industry and regulatory standards. 
  • Ensure appropriate resources are allocated and implemented for Manufacturing investigation compliance.  
  • Develop and improve policies, procedures and business practices to maintain and/or enhance compliance status. 
  • Implement the concepts of Operational Excellence and Structured Problem solving to appropriate systems and processes to enable the efficient and effective investigations.  
  • The position effects continuous-improvement initiatives by: 
    • Leading a team of professionals with specialized job functions addressing Manufacturing investigations.
    • Mapping and identifying metrics to monitor current business processes and identifying and implementing process improvements. 
    • Building cross-functional workgroups and teams and facilitating identification of goals and delineation of responsibility. 
    • Communicating systems improvements effectively to ensure efficient adoption.
    • Documenting systems improvements in SOPs and policy documents.
  • Represent the company at regulatory inspections and audits, and defend Manufacturing processes, practices and documentation systems. 
  • Represent Manufacturing in cross-functional meetings and project teams. 
  • Establishes efficient processes and systems to track and report status of initiatives including resources, projects, savings, etc.  
  • Develops team strategy and budget. Responsible for ensuring the quality and quantity of work produced, staffing requirements, and personnel management.
  • Other duties as assigned.  


Education Required 

  • PhD with at least 4 years of experience in a relevant functional area  
  • M.S. with at least 6 years of experience in a relevant functional area  
  • B.S. with at least 8-10 years of experience in a relevant functional area


Experience Required 

The position requires: 

  • Demonstrate expertise with Quality Management Systems
  • Ability to work independently, managing projects and meeting established timelines.  
  • Comfortable with managing the activities of other staff members.  
  • Computer literacy is required.  Experience with Quality Management systems) is preferred.  
  • Prior people management experience preferred. 


Supervisor Responsibility 

Management of the Manufacturing Investigations staff. 


Competencies Required 

The position requires: 

  • Strong leadership skills 
  • Strong problem solving skills
  • Strong facilitation skills
  • Well-developed organization skills with exact attention to details. 
  • Strong deductive reasoning skills 
  • Excellent written and verbal communication skills. 



  • Accountability 
  • Achieving Excellence 
  • Communication 
  • Courage / Challenge 
  • Develop Self & Others 
  • Judgement 
  • Reliability 
  • Teamwork 



  • GMP Acumen 
  • Lean Six Sigma Black Belt certification (preferred)
  • Critical Thinking & Evaluation                                      
  • Influencing                                                                  
  • Organizational Awareness                                           
  • Performance Management                                          
  • Self-Knowledge                                                          


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. 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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
United States

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