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Director, QA Operations

Location Novato, California
SUMMARY

The Director of Quality Assurance Operations is responsible for not only assessing and releasing clinical and commercial product from three production facilities, but also providing end to end quality oversight of the manufacturing facility by leading change and engraining a quality culture.  This role requires the ability to integrate technical, regulatory, and business opportunities to enable the organization to achieve and exceed the business goals in a cGMP compliant manner.  This Leader would assess and develop the talent required to maintain alignment across quality systems and escalate issues while monitoring production activities for potential risks and issues.  The BioMarin Novato Galli facility manufactures multiple commercial and clinical biologic products through Formulated Bulk Drug Substance.  

The successful candidate will lead a team of about 18 Quality professionals, engaging in both functional and cross functional projects to improve product quality and create a dynamic learning environment for staff development.  This leader will interact with members of the site leadership team as well as leaders from other functions, including Supply Chain, Finance and Engineering.   incumbent will lead a high-performing, team based organization where colleagues are flexible, multi-skilled and empowered to make decisions. 

This position requires deep understanding and proven application of cGMP regulations and international guidelines (ICH, ISPE, WHO, etc.) in a production setting.  This knowledge would combine with clear decision making and align with quality risk management principles to demonstrate release of API material appropriate for clinical and commercial use. 

RESPONSIBILITIES

The Director acts as a leader for Quality Assurance at the site level and is responsible for assessing and releasing API for clinical and commercial use. 

  • Identify, develop and lead the QA Operations team in review and release of API materials, applying the cGMPs as defined in the Quality Systems.
  • Mentor, advise and develop staff by providing strategic feedback and opportunities so they enjoy their careers at BioMarin.
  • Through actions, drive a science and risk based culture of Quality across the manufacturing facilities.
  • Provide technical expertise and leadership across all aspects of product manufacturing, including raw materials, warehouse activities, engineering, quality control, manufacturing and operations support.
  • Advise, monitor and oversee the batch record review process, including escalation of issues, driving completion of deviations and investigations, escalating to the Material Review Board.
  • Identify opportunities to improve quality, reduce cycle time, reduce COGs, and increase operational efficiency. Partner with key stakeholders to prioritize projects aligning with the quality goals and objectives.
  • Creates and maintains metrics that drive action in both QA and manufacturing areas. 
  • Manages department budget, goals and objectives, assuring alignment with key stakeholders. 
EDUCATION

Required Education:

  • Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical), math, engineering, industrial engineering or a related field.

Preferred Education:

  • Advanced degree in technical or business administration related field.

EXPERIENCE

Required Experience and Abilities:

  • 10+ years of relevant operations experience
  • 5 years in a leadership role with demonstrated management skills and business acumen
  • Demonstrated ability to manage a lot release process, including COA aspects.
  • Superior communication skills in presenting data and concepts, as well as defending company systems to auditors and cross-functional audiences.
  • Able to provide oral, written, and formal presentations to senior management, middle management and line staff.
  • Deep understanding of Health Authority regulatory requirements, guidelines and expectations.
  • Proven experience leading health Authority inspections.
  • Experience in successfully leading transformational change
  • Demonstrated ability to partner with other functional groups to achieve business objectives.
  • Strong attention to detail and creative problem solving skills
  • Ability to interpret and analyze statistical data, understand and resolve technical challenges, interface with internal technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting.





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We treat rare diseases, and that gives us rare opportunities. Chris Brodeur, Director, Corporate Compliance
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