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Quality Site Head, Novato Operations

Location Novato, California

SUMMARY DESCRIPTION

The Quality Site Head is a highly motivated technically knowledgeable leader with proven abilities to direct activities across the Novato Site Quality organization. The successful candidate will strengthen the Quality culture and insure the manufactured product meets all company standards and government regulations. This leader will develop a high performing team and provides leadership and guidance to the entire organization. By providing strategic direction, setting clear expectations, goals and metrics, the leader is accountable for all activities related to clinical and commercial production generated at Novato. These products and late stage projects span different platforms including enzyme replacement therapies, gene therapy and E.coli production. The leader would champion continuous improvement to drive out variability in commercial production to maintain high quality product.

This position required a broad range of knowledge and experience with biologic processes, drug development, analytical testing methods and understanding of the international regulatory landscape.

This candidate would join a team that works seamlessly to provide timely key data, standards and critical reagents to maintain and improve product quality.

SCOPE

People Leader, with a team over 110 people, working to make quality product for patients.

Leadership Responsibilities:

  • Direct activities within the Novato Site Quality Organization to ensure manufactured product meets company quality standards and government regulations.
  • Engage in developing strategic goals and objectives that align with TOPS and Global Quality.
  • Maintain full strategic responsibility for activities that monitor, review, test, report and monitor all commercial and clinical products/programs.
  • Manage development and performance of direct reports in appropriate ways that ensure they enjoy their career at BioMarin and are in the right role to achieve organizational and department goals with a productive environment.
  • Manage and administer all aspects of people processes related to the employee life cycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes. Manage and communicate compensation related information per company guidelines.
  • Coach and develop staff by providing an environment that encourages ongoing personal and professional growth. Manage and ensure the setting of realistic development goals for staff and provide regularly scheduled feedback throughout the year. Ensure staff receives appropriate knowledge and skill development and growth opportunities.
  • Engage and lead your team to:
  • Set operational objectives and business goals for their groups.
  • Establish and monitor performance measures and objectives for the department.
  • Optimize resources, looking for cross functional opportunities that create interesting roles and reducing handoffs
  • Approve and oversee improvements to Quality operational policies, plans and procedures.
  • Forecast and set department budget.
  • Monitor and control expenditures against department budget.
  • Establish overall Quality objectives and long-range goals.
  • Notify Senior Management of significant quality or regulatory issues that may impact product quality or regulatory compliance in a timely and succinct manner.
  • Prioritize, direct and participate in continuous improvement initiatives.
  • Review and sign documents as appropriate, such as APR, Investigations, CAPAs, technical documents, etc.
  • Demonstrate behaviors as identified in the TOPS Leadership Behaviors.
  • Perform any other tasks as requested by Executive Management to support Quality oversight activities.

Technical Responsibilities:

  • Establish overall site Quality organizational, managerial, and accountability structures.
  • Direct and provide guidance on Quality matters.
  • Align philosophies, processes and policies with the rest of the Quality organization.
  • Serve as the decision-maker and spokesperson for Quality operational issues at the Novato site.
    • Interpret and apply applicable 21CFR, USP, EP, JP, and ICH regulatory guidelines and directives
  • Allocates, administers and directs resources to ensure staff receives appropriate development opportunities to support the business, achieve department goals and meet business objectives.
  • Provide technical direction and leadership to direct the quality review of product documentation, including deviations, investigations CAPAs and HA observations.
  • Interface with Senior Management to set policy on product quality and assure adherence to company and governmental standards.
  • Interact on an ongoing basis with both internal and external business partners in Manufacturing/ Process Sciences to resolve operational issues.
  • Shape and influence Quality perspective and actions based on regulatory inspections and third-party audits.
  • Partner with the Manufacturing Site Head to create a strong quality culture across the site.
  • Create strong partnerships with key business partners, such as Regulatory Affairs, Compliance, Supply Chain and Process Sciences and demonstrate Quality as a competitive advantage.
  • Direct the compilation of appropriate quality performance measures, including analysis and recommendations for process improvement for Senior Management.
  • Provide expert interpretation and application of regulatory guidelines to ensure manufacturing operations, facilities, and documentation adhere to regulatory requirements, company procedures, and are consistent with industry standards.


EDUCATION

BS/MS/B.Sc/M.Sc./PhD in the life sciences or engineering.

EXPERIENCE

  • 15+ years relevant experience in pharmaceutical or related industry
  • 10+ years supervising, managing and directing teams
  • Demonstrated knowledge of cGMPs, Global Health Authority regulations and guidelines, Quality Systems and technical expertise in Drug Substance/Drug Product/Finished Goods manufacturing processes.
  • Demonstrated ability in implementing processes to deliver results.
  • Knowledge of devices, combination products and device development desirable.
  • Expertise in representing the company to Health Authorities.
  • International/global experience preferred.
  • Training and experience with six sigma tools preferred.
  • Experience with CMOs and CTOs preferred.
  • Demonstrated ability to lead change across an organization.
  • Proven collaboration skills coordinating across organizational areas.
  • Ability to interpret and relate Quality standards across a large, diverse team.
  • Ability to communicate clearly and professionally in written and verbal formats.

CONTACTS

This position will interact with all other departments throughout the organization. This position will partner and influence with Quality, Regulatory Affairs, Compliance, Process Sciences, Finance, MSATS, and other departments as required. This position requires constant contact with Senior Management across the organization.





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