(CW) Technical Manager, QA (Contract)

BioMarin Pharmaceutical Inc.•Novato, CA

20d•Hybrid

About The Position

The Technical Manager, QA is responsible for owning and continuously improving BioMarin’s global Supplier Quality Management (SQM) processes, particularly the Supplier Change Notification (SCN) and Approved Supplier List (ASL) processes. As Business Process Owner, this role is accountable for process efficiency and effectiveness and for developing and executing processes, programs, and initiatives that support the performance of GMP material suppliers for Drug Substance and Drug Product manufacturing. The role contributes to a risk-based approach to SCN management, leads periodic process reviews and updates, establishes governance and controls for consistent application across the supply base, evaluates process health, and drives continuous improvement. The position collaborates with internal and external stakeholders across sites and functions, including Supply Chain, Compliance, Global Sourcing and Procurement, Global Manufacturing Sciences and Technology, and other site functions. It requires supplier management knowledge, technical expertise, and business acumen. This is a contract, hybrid role with three days per week in the Novato, California office. The role also supports the organisation’s environmental protection, injury prevention, and continual improvement of EHS management systems by identifying hazards, reporting incidents, and participating in EHS initiatives and training.

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 experience such as Manufacturing, Quality, and Regulatory.
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, with 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 processes to monitor SCNs using key performance indicators, trend analysis, and regular reviews; identify and lead improvement opportunities.
Serve as Business Process Owner for the SCN and ASL processes, monitoring and maintaining their health, driving continuous improvement, 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 applicable actions.
Collaborate with global, site, internal, and external stakeholders to identify, define, and implement improved SCN workflows aligned with organizational goals and strategies; promote knowledge sharing and best practices.
Develop, implement, and communicate quality policies and procedures to ensure consistency across the network and alignment with global processes.
Support implementation of enhancements to the SCN and ASL processes.
Provide subject matter expert support for site and global inspections and related observation responses.
Support environmental protection, injury prevention, and continual improvement of EHS management systems; identify hazards, report incidents, and participate in EHS initiatives and training.