Sr. Manager, Global QMS

Location:  Novato, California Category: Quality

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Description

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

About Technical Operations

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 Senor Manager, Global Quality Management Systems will be responsible for owning and continuously improving one or more global Quality Management System (QMS) processes at BioMarin.  As Business Process Owner (BPO), they are accountable for the design and overall efficiency / effectiveness of the QMS process(es), along with driving global compliance and process performance.  They will establish the governance structure and controls to ensure the QMS process is consistently applied across the TOPS organization, ensure the health of the QMS process is continuously evaluated, and drive continuous improvement.  The person in this role will also ensure compliance risks for the QMS process are understood and mitigated appropriately.
Cross functional collaboration with partners and stakeholders across different sites and functions is key for success in this role.   This includes collaboration with Business Process Managers (BPMs) responsible for site/functional oversight of the QMS process(es). In collaboration with the BPMs, the Senior Manager QMS will ensure that these key processes are compliant, agile and support the business needs of the operation.
This position requires knowledge and experience with quality assurance and quality management system processes. The leader must possess leadership qualities, business acumen and technical expertise in the areas of responsibility.
RESPONSIBILITIES
 
  • Develop, establish and maintain compliant, risk-based and fit-for-purpose global quality management system (QMS) process(es) and procedures ensuring effective implementation.
  • Serve as the Business Process Owner (BPO) for one or more (QMS) process(es), proactively monitoring and maintaining the health of the process and subprocesses and sustaining compliance with current and evolving global health authority requirements and regulations.
  • Establish QMS process governance structure, leading and partnering with a matrix team of Business Process Managers (BPMs). Collaborate with BPMs and other global and site stakeholders to identify, define, and implement opportunities for improved QMS process workflows, while aligning QMS process with organizational goals and strategies.  Promote knowledge sharing and the best practices.
  • Establish global KPIs and oversee trending of key performance metrics associated with the QMS process(es).  Support Quality Management Review activities.  Report and escalate compliance issues to management.
  • Develop, maintain, and continuously improve global training curricula and course content for the QMS process(es), partnering with BPMs on site/functional implementation.
  • Provide oversight, support issue management, and drive continuous improvement as it pertains to the eQMS/system for the QMS process(es).  Liaise with IT regarding system enhancements, driving effective prioritization in consideration of business and compliance impact.  Provide input into Quality digital technology roadmap.  Lead and/or support implementation of eQMS/system enhancement and strategic projects.
  • Responsible for the timely completion global compliance, deviation, and CAPA commitments.
  • As needed, partner with Compliance on site Quality inspections within BioMarin with the goal of compliance to regulations and site harmonization.  Provide SME support to site inspections, global inspections, and related observation responses.
 
EDUCATION
  • BA/BS/Ph. D in life sciences or related field
  • Advanced degree desirable, but not required.
 
EXPERIENCE
 
  • 8+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
  • Experience in Quality Systems required, with experience across multiple systems/processes preferred
  • Experience with Veeva eQMS preferred
  • Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
  • Prior experience and knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required.
  • Ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.
  • Leadership, interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
  • Ability to present data and defend approaches in front of senior management and inspectors.
  • Ability to partner with other functional group to achieve business objectives.



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.

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.

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