(CW) Technical Manager, QA (Contract)

BioSpace; Novato (CA); On-site; USD 150,000 - 220,000; Full time

Job summary

BioMarin seeks a Technical Manager to own and continuously improve global Supplier Quality Management (SQM) processes, including SCN and ASL. You will lead cross-functional teams, establish governance, and drive improvements to ensure supplier performance for GMP material suppliers supporting BioMarin’s drug substance and product manufacturing.

You will work with BioMarin sites worldwide, ensuring health of the SQM process and compliance with evolving global health authority requirements.

Qualifications

• 6+ years of experience in biotech/pharmaceuticals or other highly regulated industries.
• Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
• Prior experience and knowledge in Supplier Quality, Compliance, or related areas such as Manufacturing, Quality, and Regulatory.

Responsibilities

• Lead quality-related reviews and cross-functional teams as SME for Supplier Change Notifications.
• Oversee management of BioMarin’s Approved Supplier List and related quality activities.
• Establish KPIs, trend analyses, and regular reviews to identify and lead opportunities for improvement.
• Act as Business Process Owner for SCN and ASL processes, maintain process health and drive continuous improvement.
• Review and approve Supplier Change Notifications in the Quality Management System (QMS).
• Collaborate with global and site stakeholders to implement improved SCN and ASL workflows, aligning with company goals.
• Develop and communicate quality policies to ensure consistency across the network.
• Support enhancements to SCN and ASL processes and provide SME support to inspections.

Skills

Supplier Quality

GMP/GDP knowledge

Cross-functional collaboration

Project management

Data presentation

Education

BA/BS in life sciences

Job description

Responsible for owning and continuously improving one or more global Supplier Quality Management (SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable for the overall efficiency/effectiveness of the Supplier Change Notification (SCN) process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager will be accountable for developing, executing associated processes, programs, and initiatives to ensure overall supplier performance for GMP Material Suppliers to support BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the implementation of a risk-based approach to the management of SCNs and lead efforts for periodic review and updates. They will establish the governance structure and controls to ensure the SCN and ASL processes are consistently applied across the supply base, ensure the health of the SQM process is continuously evaluated, and drive continuous improvement.

(SQM) processes at BioMarin. As Business Process Owner (BPO), they are accountable

for the overall efficiency/effectiveness of the Supplier Change Notification (SCN)

process and Approved Supplier List (ASL) process at BioMarin. The Technical Manager

will be accountable for developing, executing associated processes, programs, and

initiatives to ensure overall supplier performance for GMP Material Suppliers to support

BioMarin’s Drug Substance and Drug Product manufacturing. They will contribute to the

implementation of a risk-based approach to the management of SCNs and lead efforts for

periodic review and updates. They will establish the governance structure and controls to

ensure the SCN and ASL processes are consistently applied across the supply base, ensure the health of the SQM process is continuously evaluated, and drive continuous

improvement.

Cross functional collaboration with external and internal partners and stakeholders across

different sites and functions is key for success in this role. This includes collaboration

with Supply Chain, Compliance, Global Sourcing and Procurement (GSP), Global

Manufacturing Sciences And Technology (GMSAT), And Other Site Functions.

This position requires knowledge and experience with supplier management processes.

The person must possess technical expertise and business acumen in the areas of responsibility.

Responsibilities

• Lead Quality-related reviews, cross-functional process teams, serving as a subject matter expert for Supplier Change Notifications.
• Lead all quality aspects for the management of BioMarin’s Approved Supplier List.
• Establish process to monitor SCNs through key performance indicators (KPIs), trend analysis, and regular reviews, identifying and leading opportunities for improvement.
• Serve as the Business Process Owner for SCN and ASL process(es), proactively monitoring and maintaining the health of the process and subprocesses, driving continuous improvement efforts, and sustaining compliance with current and evolving global health authority requirements and regulations.
• Review and approve Supplier Change Notifications in the QMS.
• Make decisions and act with authority to carry out actions as applicable.
• Collaborate with external/internal global and site stakeholders to identify, define, and implement opportunities for improved SCN process workflows, while aligning the process with organizational goals and strategies. Promote knowledge sharing and the best practices.
• Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
• Support implementation of program enhancements to SCN and ASL processes.
• Provide SME support to site inspections, global inspections, and related observation responses.

Education

• BA/BS in life sciences or related field

Experience

• 6+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other highly regulated industry
• Knowledge and experience in GMP and GDP global regulations, principles, concepts, practices, and standards.
• Prior experience and knowledge in Supplier Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory

Required. Knowledge In International Regulatory Landscape Preferred.

• Demonstrated ability to work effectively in a matrix environment and drive results through “influence” as well as direct management.
• Organizational and management skills, with ability to effectively plan, schedule, execute, and track complex projects.
• Excellent interpersonal and communication skills and ability to influence diverse stakeholders and drive accountability and decision-making cross functionally.
• Ability to present data and defend approaches in front of management and inspectors.
• Ability to partner with other functional group to achieve business objectives.

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.