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Quality Director, Global QMS

Location United States, Remote

Workstyle Remote Only

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 DESCRIPTION

The Director Quality Global QMS will be responsible for managing and continuously improving the Quality Management System at BioMarin. They will set up appropriate governance and controls to ensure the quality management system is consistently applied across the TOPS organization, the health of the quality management system is continuously evaluated and the governance to drive continuous improvement is in place and effective. The person in this role will also ensure compliance risks across the quality management system are understood and mitigated appropriately.

Cross functional collaboration with partners and stakeholders across different sites and functions is key for success in this role. A group of business process owners responsible for owning several quality processes (e.g., Change Control, Quality Risk Management, Deviation Management, CAPA) within the QMS will report into the role. In collaboration with the team of Quality professionals, the Director Quality Global QMS will ensure that these key processes are compliant, agile and support the business needs of the operation.

This position requires in depth knowledge and experience with quality assurance and specifically a well-established and operating quality management system. The leader must possess strong leadership qualities, business acumen and technical expertise in the areas of responsibility.

RESPONSIBILITIES

  • Establish and maintain risk-based and fit-for-purpose global quality management (QMS) system ensuring effective implementation, which is managed and continuously improved to sustain compliance with current and evolving global health authority requirements and regulations effectively and efficiently.
  • Provide leadership, and direction to a team of Global Business Process Owners responsible for establishing, owning, and continuously improving critical Quality Processes as part of the BioMarin Quality Management System.
  • Establish a process that drives network collaboration with cross functional stakeholders to identify, define, and implement continuous improvement opportunities within the QMS Quality Processes.
  • Own, maintain and evolve the QMS infrastructure so that it supports current and future needs of the business.
  • Support Quality Management Review activities and oversee trending of key GMP quality management system performance metrics. Report and escalate compliance issues to management.
  • Collaborate with global and site stakeholders to identify, define, and implement opportunities for improved QMS Process Workflows
  • Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
  • Mature the Quality Risk Management (QRM) program. Collaborate with key stakeholders within TOPS in QRM knowledge management, definition of roles and responsibilities and overall integration of QRM.
  • Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
  • Provide input in Quality digital technology roadmap and support its implementation.
  • Lead and mentor a team of Quality professionals to navigate and lead in a matrix organization.
  • Drive team expansion and talent acquisition efforts, playing a pivotal role in selecting and onboarding key talent.
  • Develop and manage department budgets and long-range plans for the team.

EDUCATION

  • BA/BS/Ph. D in life sciences or related field
  • Advanced degree desirable, but not required.

EXPERIENCE

  • 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
  • Extensive knowledge and experience in GMP, GCP and GDP global regulations, principles, concepts, practices, and standards.
  • Prior experience and broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. Knowledge in international regulatory landscape preferred.
  • Experience in Quality Systems; Combination Products/Device Quality desirable.
  • 8+ years of prior management level experience with demonstrated ability to develop and mentor staff.
  • Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.
  • In-depth experience in managing teams, and in providing coaching, development and mentoring to employees. 
  • Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
  • Demonstrated ability to partner with other functional group to achieve business objectives.



Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.



In the U.S., the salary range for this position is $ 164,000 to $ 246,000 per year, which factors in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. A discretionary bonus and/or long-term incentive units may be provided as part of the compensation package, in addition to the full range of medical, financial, and/or other benefits, dependent on the level and position offered.

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