Associate Director, Quality Operational Excellence

Novato, California
May 16, 2022
Quality, Quality Control
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

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. Come join our team and make a meaningful impact on patients’ lives.


The Associate Director Quality Operational Excellence owns our portfolio of continuous improvement projects and leads the growth of the Operational Excellence culture within BioMarin’s Technical Operations Global Quality organization. This role requires the ability to integrate technical, regulatory, and business opportunities to define and enable the Quality organization to efficiently meet our annual Quality Goals and objectives in alignment with our long-term strategy.  The Associate Director reports to the Sr. Director of the Quality Excellence & Strategic Planning function and is a member of the Extended Quality Leadership Team. This role requires working closely with the Quality leadership team, TOPS (Technical Operations) Operational Excellence community, Portfolio Management Team, and site Business Operations teams. The Associate Director will achieve this by effectively driving strategy deployment and execution for the Quality organization through the identification and tracking of annual objectives, defining and prioritizing the supporting Continuous Improvement project portfolio to ensure alignment and consistency with global business strategies, and the building of Operational Excellence competencies and capabilities throughout the Quality organization. 



The Associate Director acts as a leader for Strategy deployment and Realization for the Quality organization and is responsible for the following: 

  • Managing the Quality Operational Excellence program deployment in alignment with Quality objectives and the TOPS OE Roadmap 
  • Works closely with Business Process Integration (BPI) and OE community to ensure support and alignment with global processes and programs 
  • OE Competency & Capability building for the Quality organization (Global and Site) by serving as a trainer and coach 
  • Identifies opportunities to improve quality, reduce cycle time, reduce COGs, and increase operational efficiency.  
  • Directs Continuous Improvement project prioritization and selection to maximize business and financial impact, and maintain alignment with strategic objectives. Leads the planning and execution of high-impact improvement projects and strategic initiatives. 
  • Oversees the supporting continuous Improvement project portfolio  
  • Oversees the Quality project prioritization process and project resource management 
  • Oversees the establishment of efficient processes and systems to track and report status of initiatives including resources, projects, savings, etc.  
  • Create and maintains operational and financial metrics dashboards and reports that accurately measure improvement savings and return on investment (ROI). 
  • Works with Quality leaders to establish continuous improvement goals and act as a liaison with finance to build CI budgets and validating actual improvement results.  
  • Manage the annual objectives and goal setting process and progress monitoring for the Quality organization.   
  • Lead Quality Leadership team in annual objective and goal setting process 
  • Partner with Quality Network Strategy to ensure alignment between annual objectives/goals with long term Stategic objectives 
  • Develop and maintain mechanism to drive alignment between Global Quality and Quality Site/functional goals 
  • Track and report on status of annual objectives and goals (Global/Site/Functional) 



Required Education: 

  • Bachelor's degree in business management, information systems, engineering, math, science (e.g., biology, chemistry, pharmacy, medical), or related field. 

Preferred Education: 

  • Lean Six Sigma Master Black Belt certification  
  • Advanced degree in technical or business administration related field. 
  • Project Management Institute (PMI) or Project Management Professional (PMP) certification 



Required Experience and Abilities: 

  • 10+ years of relevant operations experience 
  • 5 years in a leadership role with strong management skills and business acumen 
  • Superior communication skills.  Able to provide oral, written, and formal presentations to senior management, middle management and line staff. 
  • Experience in successfully leading transformational change 
  • Demonstrated ability to partner with other functional groups to achieve business objectives. 
  • Ability to effectively lead cross-functional project teams. Escalates and drives resolution of project issues. 
  • Strong attention to detail and creative problem-solving skills 
  • Ability to interpret and analyze statistical data and financial reports, understand and resolve technical challenges, interface with internal technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting. 
  • Experience in portfolio management and resource management 


Preferred Experience: 

  • 10 years project planning and management including successful implementation of highly complex business and technology initiatives. 
  • 4 years managing and influencing people 
  • Prior management level experience with demonstrated ability to develop and coach others 
  • Experience in developing business strategies 

PLEASE NOTE: Absent a Medical or Religious reason that prohibits vaccinations, all our incoming employees must be vaccinated for COVID-19.

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.