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 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.b
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.
