Quality Management Process Lead

San Rafael, CA

Employer:

Description

BioMarin has experienced substantial growth organically since its inception, primarily over the last decade. While this steady growth in both cost structure and staff was essential to BioMarin's emergence as a leading, fully integrated global biopharma with approximately $2 billion in revenues from over 75 countries, a robust R&D pipeline, operating profits, and world-class technical capabilities through its 3,000 employees; BioMarin leadership desires to optimize the efficiency of its operations for the future through its next phase of growth.

BioMarin launched its "Enterprise Resource Planning" (ERP) enterprise-wide operational initiative in Q1 2022. T he implementation of a new Enterprise Resource Planning (ERP) system is critical for supporting that tomorrow for our patients and our people. An effective ERP will support bridging our planning, transactional processes, and information to meet the needs of a maturing and growing organization.

Implementing a new ERP impacts the entire company - putting this system in place is equally complex and transformational. The project team is built around the Global Process Workflows as outlined below:

Record to Report
Order to Cash
Procure to Pay
Plan to Make
Inventory to Deliver
Forecast to Plan
Enterprise Asset Management

The Global Process Owners (GPO) are accountable for the development and integration of the workstream into the overall program and the Process Leads will report to them. Process Lead is accountable and responsible for their level 2 business process, including master data, system integrations, process & system design, training and rollout of process improvements.

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 individuals 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.

Key Responsibilities

Leads and manages a team of super users and function Business Process Managers responsible for Quality Management business processes
Leads development of business process design, system design, and implementation activities
Coordinates with development/configuration team for development related to workstream
Manages scope of the process team
Understands functions and features of ERP module(s)
Manages and confirms the proper integration with other process workstreams
Prepares key issues, provides options for fast decision making by global process owners and steering committee
Reports issues, risks, and scope questions
Identifies and works to prepare business case for identified gaps
Key participant in design workshops not only to align on their respective work stream but to work cross functionally to ensure that the end to end of the business process are integrated across all work streams
Be a change champion for the project functionally and cross functionally
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.
Build partnerships and collaborate with global, functional, and regional teams on operational, and planning initiatives.
Other duties as assigned.

Critical Attributes

The Process Lead will be a role that requires a growth mindset and dynamic set of business and collaboration skills, including the following:

Great collaborator across all BioMarin, Systems Integrator and SAPpersonnel
Effective change leader to prepare BioMarin to adopt industry best practices
Effective communication, persuasion and influencing skills at all levels
A bias for action and a "can do" attitude
Solutions oriented
Other desirable attributes include work experience in a similar transformational effort such as an ERP S4/HANA program or similar enterprise/local deployment in the bio-pharma context.

Key Working Relationships:

Partnering across supplier/customer process leads to ensure enterprise integrated solution
Partner with Price Water-House Coopers (PwC) workstream lead on business solution
Partner with sponsor(s) on allocation of resources and alignment on business solution and implementation strategy
Partner with Information Management (IM) workstream leads to ensure business and technology solution achieve business objectives
Partner with PMO lead manage critical milestones and address implementation risks
Partner with OCM lead to assess and align on change management plan to prepare the business for business transformation realization
Partner with ERP program lead on overall strategy, risk management and implementation of integrated business solution

Job Requirements:

Experience / Education: 10 or more years of experience related to Quality Management business Processes and systems, with clear demonstration of progressive achievement and growth.
Knowledge and experience in of all elements of the business process cycle (refer to table in appendix)

Two years of leadership responsibility managing midsize teams and influencing senior-level management and key stakeholders.

Skills / Competencies

Strong understanding of other financial and supply chain operational process flows (i.e., order to cash, procure to pay, record to report, hire to retire, etc.)
Ability to develop strong partnership with the business community. Self-motivated and a problem solver who can assess and develop strategies for achieving the needs of the user community.
Drives operational efficiency and identifies, documents, and monitors key business processes within the scope of their business process to achieve successful business results. Analyzes, maps and documents process and develops a framework for process standardization and improvement
Effective verbal, written and interpersonal skills. Ability to speak to technical-level staff and develop written reporting and presentational content with level-appropriate messaging up to and including the senior executive level.
Demonstrated ability to work in a matrix environment, particularly in cross-functional teams across multiple lines of business, over whom there may be no direct authority.
Demonstrated change leader implementing strategies to move the organization through the change management curve and align to industry best practices process standards.
Excellent project management skills, with demonstrated track record of applying program management principles, practices, and techniques with a strong results orientation

Business Process Scope

Quality Management Process lead is responsible for the following business processes and collaborating with process leads on integrations with other L2 processes.

L1

L2

L3

PTP

Quality Management

Quality Master Data

PTP

Quality Management

Inbound Material Inspections

PTP

Quality Management

LIMS & QMS Integrations

PTP

Quality Management

Quality Planning

PTP

Quality Management

Quality Control Inspections

PTP

Quality Management

Product Release Controls

PTP

Quality Management

Certificates & Notifications

PTP

Quality Management

Reports and Analytics

PTP

Quality Management

Engineering Change Management

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.

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.

The salary range for this position is: $136,700 to $205,100. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.

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.

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