The Director, Supplier Quality, is responsible for Quality Assurance, compliance and Supplier Development activities.
The successful candidate will establish, manage, maintain and continuously improve all quality activities associated supply and contract services including raw materials, components, packaging materials, packaging locations, manufacturing support services and testing laboratories.
· Responsible for the leadership of employees as well as coaching and development QA professionals at all levels of the organization.
· Establish a Quality strategy and supplier relationship to ensure compliance for all Pharma suppliers and contract packaging and testing support services. Will manage the strategy and relationship to ensure that compliant systems and procedures are in place from development and throughout the commercialization life cycle.
· Lead the ongoing development of suppliers in areas such as quality initiatives, cost improvements lead time reduction.
· Ensure the proper balance of business and compliance needs. Manage this balance to optimize continuous growth at the supplier and contractor locations.
· Directs and provides GMP assessments for potential new suppliers.
· Develops policies and requirements for Supplier Quality Management Systems in order to minimize compliance and product quality risk while increasing business portfolio.
· Writes, negotiates and ensures execution of Quality Agreements. Facilitates the resolution of supplier issues as required.
· Establish, maintain, analyze, report and continuously improve the Supplier Quality Performance Measurement system. Identify opportunities to continually improve quality, cost and time factors, consistent with the business objectives.
· Lead, sell and implement improvement opportunities and problem solutions.
· Provide regulatory interpretation, consulting, training and assessment to ensure PDx Supplier Quality is aligned with current regulatory requirements, company standards and industry trends.
· Serves as technical expert for Supplier Management.
· Represents Supplier Quality during Regulatory Inspections.
· Understanding customer needs, marketplace dynamics, industry trends, competitive landscape in the industry, considers the external impact of business activities and decisions on the external environment
· Bachelor's degree and extensive business experience or equivalent knowledge or experience
· Previous people management experience. Experience managing multiple leveled employees in a global capacity is preferred.
· Expert knowledge of Good Manufacturing Practices & Regulatory requirements.
· Ability to clearly communicate to a variety of audiences, both big picture ideas as well as technical details.
· Strong project management and prioritization skills, ability to effectively manage multiple tasks and priorities
· Superior ability to lead change with global, cross-functional teams
· Proven ability to drive operational excellence
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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