(CW) Technical Manager, QA (Contract)

BioMarin Pharmaceutical•Novato, CA

18d•Hybrid

About The Position

BioMarin is a rare disease biotechnology company developing medicines for genetically defined conditions. Its Technical Operations group creates drugs for clinical trials, scales commercial production, and supports manufacturing through engineering, quality, procurement, and global distribution. The Technical Manager, QA is a contract, hybrid role based in Novato, California, with three days per week in the office. The role owns and continuously improves global Supplier Quality Management processes, serving as Business Process Owner for the Supplier Change Notification (SCN) and Approved Supplier List (ASL) processes. The position is accountable for the efficiency and effectiveness of these processes and for supplier performance programs supporting GMP material suppliers for Drug Substance and Drug Product manufacturing. The role develops and executes processes, programs, and initiatives; contributes to a risk-based approach to SCN management; establishes governance and controls for consistent process application; monitors process health; and leads continuous improvement. Success requires collaboration with internal and external stakeholders across functions and sites, including Supply Chain, Compliance, Global Sourcing and Procurement, and Global Manufacturing Sciences and Technology. The position also requires supplier-management knowledge, technical expertise, and business acumen.

Requirements

Bachelor’s degree in life sciences or a related field.
At least 6 years of experience in biotechnology, pharmaceuticals, medical devices, or another highly regulated industry.
Knowledge and experience with global GMP and GDP regulations, principles, concepts, practices, and standards.
Prior experience and knowledge in Supplier Quality, Compliance, or a combination of Manufacturing, Quality, and Regulatory experience.
Ability to work effectively in a matrix environment and drive results through influence as well as direct management.
Organizational and management skills, including the ability to plan, schedule, execute, and track complex projects.
Excellent interpersonal and communication skills, including the ability to influence diverse stakeholders and drive cross-functional accountability and decision-making.
Ability to present data and defend approaches before management and inspectors.
Ability to partner with other functional groups to achieve business objectives.

Nice To Haves

Knowledge of the international regulatory landscape.

Responsibilities

Lead quality-related reviews and cross-functional process teams, serving as a subject matter expert for Supplier Change Notifications.
Lead all quality aspects of managing BioMarin’s Approved Supplier List.
Establish a process for monitoring SCNs through KPIs, trend analysis, and regular reviews; identify and lead improvement opportunities.
Serve as Business Process Owner for the SCN and ASL processes, monitor and maintain their health, drive continuous improvement, and sustain compliance with current and evolving global health authority requirements and regulations.
Review and approve Supplier Change Notifications in the QMS.
Make decisions and take actions within the authority applicable to the role.
Collaborate with global and site stakeholders to identify, define, and implement improvements to SCN workflows while aligning processes with organizational goals and strategies; promote knowledge sharing and best practices.
Develop, implement, and communicate quality policies and procedures to support consistency across the network and alignment with global processes.
Support implementation of enhancements to the SCN and ASL programs.
Provide subject matter expertise for site and global inspections and related observation responses.
Support environmental protection, injury prevention, and continual improvement of EHS management systems; contribute to a safe workplace by identifying hazards, reporting incidents, and participating in EHS initiatives and training.