Senior Manager, Quality SAP
Location Novato, California Workstyle Hybrid ApplyWho 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.
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
Hybrid role, requiring 2 days on-site per week in Novato, California. Additional days on site will be needed based on business need or activities on-going at the Novato site.
The Senior Manager, Quality SAP, reporting to the Novato Head of Quality Systems & Compliance, is responsible for overseeing SAP implementation and sustainment as part of the Novato Site Quality team, as well as partnering the site readiness team. The Senior Manager, Quality SAP, will manage a team of Quality SAP superusers and ensure execution of key implementation activities, including Master Data review, User Acceptance Testing (UAT), document updates, training material development, and change control management. This role is crucial in ensuring compliance and efficiency throughout the implementation and sustainment process of SAP for Site Quality as well as overall Novato functions.
Key Responsibilities
- Lead and mentor a team of Quality SAP superusers, fostering a collaborative and high-performance work environment.
- Oversee the implementation of SAP within the quality group, ensuring all processes meet business process needs.
- Conduct assessments to understand the impact of SAP implementation on current processes and systems, developing mitigation actions as appropriate.
- Help develop and implement processes for enabling the simplification and standardization of practices in line with the SAP first and fit to standard design philosophies.
- Collaborate cross-functionally to develop and execute a detailed cutover plan to transition from Oracle to SAP.
- Partner with the site readiness team to ensure successful preparation and execution of site readiness activities.
- Engage in project workstream design sessions to learn about new system capabilities and processes early and provide input to workstreams (e.g., as a SME).
- Lead the review of Quality Master Data to ensure accuracy and completeness.
- Coordinate and support UAT activities, ensuring that all quality functions are thoroughly tested and validated.
- Oversee the updating of relevant documents to reflect new processes and procedures introduced by SAP implementation.
- Work with the training group to develop and deliver training programs for Novato Site Quality Users and other stakeholders to ensure a thorough understanding of new processes and compliance requirements.
- Manage change control processes to ensure that all changes are properly documented, reviewed, and approved.
- Be a change champion for the project functionally and cross functionally.
- Address and resolve any issues related to SAP quality processes, providing expert guidance and support to the team.
- Provide feedback, input, and raise questions or issues with the Ignite team as identified.
- Ensure that all operational aspects are ready for SAP go-live. Escalate as needed and share up-to-date information about the project with Quality Leadership.
- Serve as the first line of support for technical questions and troubleshooting within their functional area.
- Drive knowledge management, sustainable knowledge transfer, continuous improvement & management within function.
- Other duties as assigned.
Experience:
- 10 or more years of experience related to Quality Management Business Processes, with clear demonstration of progressive achievement and growth.
- Excellent leadership and team management skills.
- Effective communication, persuasion and influencing skills at all levels.
- Ability to develop strong partnership with the business community and the Ignite team.
- Self-motivated and problem solver who can assess and develop strategies for achieving the needs of the user community.
- Strong knowledge of SAP Quality modules.
- Strong understanding of Quality Master Data.
- Proven ability to drive process improvements initiative.
- A bias for action and a “can do” attitude.
- Previous experience with S4/HANA program highly desired with good understanding of functions and features of SAP module(s).
Education:
- BA/BS in life sciences or related field.
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
For additional benefits information, visit: https://careers.biomarin.com/benefits.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.