Director, Global Quality Strategy and Business Operations
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.
- Design and implement when require operating business processes and solutions to support harmonization across the global network.
- Responsible design, logistics and execution/facilitation of the global quality meetings and events designed to develop strategies, monitor performance and enable the organization effectiveness throughout the year.
- Responsible to define and coordinate the executive agenda for the CQO site visits effectiveness with the corresponding GQ members and related stakeholders.
- Collaborate and support the TOPS and GO Strategy Business Operations lead in required tasks to have appropriate material for Town Halls, Communications and or Strategy meetings and reporting throughout the year.
- Guide, alongside the CQO, the strategic direction of the Quality Organization to ensure that its annual objectives are in sync with the broader goals established in TOPS and WWRD, as well as the aims of BioMarin's various collaborators.
- Oversee strategic goals implementation, ensuring that goals are achieved or redirecting focus promptly when necessary. Develops overall strategy for effective communication deployment and engagement across teams and presentations on behalf of the CQO.
- Oversee and track the implementation of key GQ projects in relation to set goals, measuring both progress, results and financial impact if any. Provide regular reports and suggestions concerning the advancements, potential risks, and necessary measures needed to achieve objectives.
- Responsible for the development, execution, updates and cascading of Global Quality performance Goals and strategic projects KPIs monitoring objectives/initiatives in execution in alignment with key stakeholders across the GxP.
- Execute key strategic initiatives when required for the Global Quality Organization such as, Organizational Transformation, Operational Business Processes, Operational Excellence project impacting strategic goals, and cross-functional projects to support business strategies & execution.
- Prepare and facilitate quarterly management performance and strategy reviews of ensuring seamless planning of activities, and project portfolio prioritization cycles.
- Leverages metrics/scorecard to identify and lead continuous improvement & OE projects and serve as point of contact for Operational Excellence organization and as single contact point for strategic planning processes.
- Supports the GQLT in the budget process to ensure it is vetted before presenting to CQO and that to support the strategy in balance with tactical needs
- Plan and proactively schedule all People related activities ensuring they are managed in a timely manner throughout the organization, i.e., Talent IDP, Mid-Year Reviews, Succession Planning, etcLeadership Responsibilities:
- Embodies a compliance, quality, and continuous improvement mindset.
- Ensures continuous innovation to deliver leading edge, fit for purpose solutions to the organization
- Active and visible change agent, promoting flexible and open mindsets to new opportunities.
- Drives (change) processes, supports employees in understanding and accepting change, and actively promotes it in the sense of servant leadership from the site perspective.
- Enables faster identification, adoption and implementation of network changes and best practices across the network.
- Sponsor project teams and champion the effective deployment of new technologies, and systems to improve quality, optimize productivity, reduce cycle times, and deliver pipeline.
- Supports strategic program, project, and initiative management in the Global Quality organization, ensuring alignment of transformation initiatives and common strategic goals.
- Executing for Results: Maintains high standards of performance consistently collaborates with all stakeholders and follows through on commitments. Takes the long view, and when faced with challenging obstacles, exemplifies always doing what is in the best interest of patients.
- Serves as a key thought partner to the SVP, CQO and the Global Quality leadership team, closely collaborating on efforts to advance Global Quality Goals
- Serves as the facilitator of the QLT and participates in network strategic discussion and serves as the primary site contact for the network strategy planning and deployment activities.
- Work closely & collaboratively with Site Operations, Global Quality Functions, Regulatory, Tech. Dev. & Services, Clinical Operations, WWRD, HR and Finance to achieve business goals.
- Leads, motivates & coaches a complex network of leaders and/or experienced specialists/experts (eQLT), empowers and inspires others by influencing on all hierarchy levels from shop floor up to senior leadership team.
- Minimum of 8-10 years of experience in the pharmaceutical/biopharmaceutical industry, with specific experience in leadership roles.
- Thorough understanding of and experience with some aspect of quality and compliance, technical operations or CMC; interest and demonstrated ability to learn across several disciplines (manufacturing, quality, supply chain, technical development, regulatory, patient experience, finance, operations, etc.).
- Demonstrated experience in developing, aligning, socializing, monitoring, adapting, and delivering strategies in dynamic, rapidly changing environments.
- Demonstrated experience in managing projects and setting up business process to operate a management office.
- Demonstrated ability to effectively lead and influence cross-functional teams not under direct organizational reporting lines to communicate challenging goals and achieve objectives.
- Possesses good financial acumen and skilled in project management and decision analysis.
- Strong computer skills. Experience developing and managing projects/programs including tools for milestones and resources.
- Strong organizational skills, ability to multi-task and work in a dynamic, fast paced environment.
- Demonstrated ability to accomplish results and meet deadlines and commitments.
- Strong interpersonal communications skills. Shares critical information with project team and senior leaders.
- Demonstrated analytical and logic skills with a focus on fact-based decision-making.
- Ability to travel ~15%.
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.