Technical Manager, Quality Analytical Technology - Novato, United States - BioMarin Pharmaceutical

Description

Who We Are 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.

Technical Manager, Quality Analytical Technology (QAT) SUMMARYThe Quality Analytical Technology (QAT) Technical Manager is responsible for project and capacity management, reporting, documentation management and metric monitoring in support of QAT team activities.

This role will provide project management support to enable successful project planning, execution and capacity management for all QAT teams, as well as reporting out on project completion status as part of the QSAT technical agenda.

In addition, the technical manager will support documentation and metric monitoring for QAT teams as required.

Under minimal supervision this position supports cross-functional partnerships across BioMarin to ensure the availability of our portfolio of products to external partners, customers and patients.

RESPONSIBILITIES

• The QAT Technical manager provides project management support to enable successful QAT planning and resource management, ensuring alignment with the QSAT technical agenda and communicating completion status with key stakeholders
• Responsible for driving, deploying, and maintaining the QAT plan in alignment with the QSAT technical agenda and maintaining the QAT project planning and capacity modelling tools
• Responsible for maintaining program management and QAT deliverables in partnership with our key stakeholders
• Effectively manage team meetings in support of project planning and reporting activities, including the scheduling of meetings, the preparation of agendas, the development of meeting minutes, and following up on action items
• Responsible for preparing QAT Team materials to communicate project progress to stakeholders, supervisors, site leadership, and various governance forums as needed e.g., status reports, milestones reporting for diverse leadership groups etc.
• Responsible for working with QSAT and external team members to create and maintain project plans and timelines, highlighting key areas of risks such as resource or budget gaps, dependencies, and target dates
• Responsible for identifying and communicating dependencies and cross-project synergies to leverage efficiencies and ensure consistencies and standardization where appropriate within QAT teams
• Identify project issues such as resource, technical or scheduling constraints and drives resolution of these issues with the QAT teams and with external stakeholders by developing program-level risk assessments, summarized options, and proposed solutions with impact statements
• Promote a culture of collaboration, cooperation, execution excellence, effective communication, and cross-functional problem-solving to enable a high-performing team
• Tracks program timelines elements to ensure that functional deliverables are completed on time and according to relevant quality standards.
• Support identifying cross-project synergies to leverage efficiencies and ensure consistencies where appropriate
• Supports training and roll out of portfolio standard and guidance.
• Manages projects supporting continuous improvements of best program management practices
• Supports completion of Veeva documentation and QMS review and approval workflows across QAT teams
• Monitors and reports on QAT team training and QMS metrics as required
• Initiates and completes Quality System processes in QMS

Manage implementation of new systems and continuous improvement efforts EXPERIENCE Required Skills:

• Minimum of 4-8 years total relevant experience (including industry, project management, or private/government institution), with at least 2-4 years in a project management role
• Minimum Bachelors' degree in scientific/technical discipline
• Demonstrated ability to organize and update a complex schedule, experience with project management software such as Microsoft project, P6 Primavera or similar applications
• Ability to understand the big picture and focus on execution details
• Familiarity with the required deliverables for analytical method lifecycle activities, such as method validation, transfers, etc.
• Experience in early-stage clinical programs
• Proven track record in a fast-paced, challenging, and complex matrixed team environment
• High degree of demonstrated learning agility
• Action-oriented with strong follow through
• Strong interpersonal skills; fluent and able to influence others in spoken and written English
• Strong risk management analysis and project management skills
• Strong computer skills, MS Office, MS Word, MS PowerPoint, MS-Project is preferred

Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment Desired Skills:

• Understanding of biotechnology or drug product development and of multi-project planning and coordination is required
• Experience with CMC activities for development programs (Clinical stage)
• Exposure to portfolio management
• Lean-DMAIC expertise, Green belt or higher certification.
• Strong regulatory and GMP acumen.
• PMP Certification EDUCATION
• Minimum Bachelors' degree in scientific/technical discipline

required

• Lean-DMAIC expertise, Green belt or higher certification desired
• PMP Certification desired EQUIPMENTStandard office equipment CONTACTSQAT leadership teamQSAT Leadership TeamPQL TeamRegulatory affairs SUPERVISOR RESPONSIBILITYN/A SHIFT DETAILSDays Monday to Friday ONSITE, REMOTE, OR FLEXIBLEFlexible (minimum 2 days per week on site) TRAVEL REQUIREDSome travel may be required, less than once per quarter 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.