Technical Manager, QA

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.

SUMMARY DESCRIPTION:

Responsible for owning and continuously improving one or more global Supplier Quality Management (SQM) processes. 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. 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 our client'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 our client'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.