Quality Process Improvement Manager Jobs in Santa Rosa, CA

Who We Are
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
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 Sr. Manager, QA, Supplier Quality Management BPO is an operational leadership role responsible for the execution, day-to-day management, and continuous improvement of core Supplier Quality Management (SQM) processes supporting BioMarin's external supply network for GMP/GDP materials. This role serves as the Business Process Owner (BPO) for the SQM quality process and is accountable for ensuring the processes are consistently applied, effectively monitored, and continuously enhanced across the global supplier base.

The Sr. Manager owns and executes the GMP/GDP material audit program, tracks and maintains key performance metrics for the Supplier Quality department and drives measurable continuous improvement initiatives. Additionally, this role leads the digitalization and AI enablement agenda for the department - translating strategic direction from the Director into practical implementation of automation, analytics, and AI-enabled tools that improve efficiency, oversight, compliance and decision-making.

The Sr. Manager also provides hands-on support to the execution of Supplier Quality Category Manager activities, partnering closely with category managers, Procurement, and Technical Operations to ensure supplier qualification, quality agreements, changes, deviations, and performance activities are executed on time and to standard.

This position requires strong GxP execution expertise, disciplined process management, and the ability to operate effectively in a matrixed, cross-functional environment with a focus on delivery, compliance, and operational excellence.

RESPONSIBILITIES

GMP/GDP Material Audit Program Management

• Manage the end-to-end execution of the GMP/GDP material supplier audit program (outsourced), including annual audit planning, scheduling, execution oversight, follow-up, CAPA tracking, and effectiveness verification.
• Ensure audits are completed on schedule in alignment with the approved audit plan.
• Coordinate internal and third-party auditors, ensuring consistent audit standards, timely reporting, and closure of audit observations.
• Ensure supplier audit outcomes, identified risks, and corrective actions are appropriately documented, trended, and integrated into Supplier Lifecycle Management and Quality Management Review processes.
• Support and represent Supplier Quality during regulatory inspections and external audits involving suppliers, providing audit program data and evidence of effectiveness.

Business Process Owner (BPO) - Supplier Quality Management Processes

• Serve as the Business Process Owner for the Supplier Quality Management quality processes, including supplier qualification and lifecycle management, quality agreements, supplier changes, supplier deviations/CAPA, and supplier auditing.
• Proactively monitor and maintain the health of these processes and their subprocesses, ensuring consistency of application across the global supplier base.
• Maintain and update associated procedures, work instructions, templates, and training materials to sustain compliance with current and evolving global health authority requirements.
• Drive process standardization, harmonization, and simplification across sites and functions.
• Partner with Quality Systems, Compliance, and IT to ensure supporting systems and workflows enable efficient and compliant process execution.

Performance Metrics & Continuous Improvement

• Define, track, and maintain the key performance indicators (KPIs) and metrics for the Supplier Quality department, including supplier performance, process health, audit program execution, and issue resolution timeliness.
• Establish and manage reporting cadences and dashboards to enable trending, signal detection, and timely management review.
• Identify improvement opportunities from metric trends and lead cross-functional continuous improvement initiatives to address them.
• Drive a culture of data-driven decision-making and operational excellence within the Supplier Quality team.
• Support management review processes with accurate, actionable performance data.

Digitalization & AI Implementation

• Lead the execution of the department's digitalization and AI implementation roadmap, in alignment with the broader Quality Digital Strategy defined by the Director.
• Identify, evaluate, and implement automation, advanced analytics, and AI-enabled solutions to improve supplier performance monitoring, risk identification, trend analysis, audit effectiveness, and process efficiency.
• Partner with IT, Quality Systems, and business stakeholders to deliver sustainable, scalable digital solutions, including requirements definition, system configuration, and change management.
• Drive effective use of Supplier Quality data by integrating information from eQMS, ERP, and external systems to generate actionable insights.
• Champion adoption of digital and AI tools within the Supplier Quality team through training, communication, and hands-on support.

Supplier Quality Category Manager Execution Support

• Support the execution of Supplier Quality Category Manager activities across assigned material categories, ensuring timely completion of supplier qualification, onboarding, and lifecycle management tasks.
• Assist in the development and maintenance of Quality Technical Agreements with global suppliers to define quality expectations and responsibilities.
• Support risk-based approaches to identify, assess, and mitigate supplier-related risks, ensuring continuity of supply and material quality.
• Provide execution support for supplier performance management (scorecards), supplier investigations, CAPAs, and change assessments as needed.
• Collaborate with category managers, Procurement, Manufacturing, and site QA to resolve supplier quality issues and drive supplier performance improvement.

Cross-Functional Collaboration

• Partner with Global Procurement, Manufacturing, Technical Development, site QA, and other stakeholders to ensure supplier quality requirements are executed effectively across the supplier lifecycle.
• Represent Supplier Quality in cross-functional process forums, working groups, and improvement projects.
• Promote knowledge sharing and consistent application of best practices across sites and functions.

People & Team Contribution

• Provide day-to-day guidance, coaching, and technical mentorship to Supplier Quality team members supporting the audit program, BPO activities, metrics, and digital initiatives.
• Support onboarding, training, and capability development within the Supplier Quality team.
• Foster a culture of quality, accountability, collaboration, and continuous improvement.

EDUCATION

• Bachelor's degree in Life Sciences, Engineering, or a related discipline required.
• Advanced degree (MS, PhD, MBA) desirable but not required.
• Six Sigma, Lean, or auditor certification (e.g., ASQ CQA) desirable.

EXPERIENCE

• Minimum of 10 years of experience in Quality Assurance, Supplier Quality, Manufacturing, or related roles within a highly regulated industry (biotechnology, pharmaceutical, medical device, or combination products).
• Solid working knowledge of global quality and regulatory requirements (e.g., GMP, GDP, ISO standards, 21 CFR).
• Demonstrated experience executing and managing supplier audit programs for GMP/GDP materials.
• Prior experience as a Business Process Owner or equivalent process ownership role within a QMS environment strongly preferred.
• Proven track record of defining and managing KPIs and delivering measurable continuous improvement outcomes.
• Hands-on experience implementing digital, automation, analytics, or AI-enabled solutions in a Quality or regulated environment strongly preferred.
• Experience working in a matrixed, global environment and driving results through influence as well as direct execution.
• Excellent communication, collaboration, and stakeholder management skills, including the ability to present data and defend approaches to senior management and inspectors.
• Strong organizational skills with the ability to manage multiple priorities and deliver on time.

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.
Ireland Safety Responsibility Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.
Ireland Safety Responsibility
Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.