Supplier Quality Manager

SUMMARY

The Supplier Quality Manager is responsible for ongoing management of quality performance, product disposition, regulatory compliance and oversight of quality issue resolution for Suppliers.  Primary responsibilities include the evaluation and qualification of potential suppliers, contractors and consultants on the basis of their ability to meet specified requirements, including regulatory, quality, safety and security requirements.

This position integrates and develops processes to qualify manufacturers, suppliers and contractors that meet business needs across the organization. In addition, this position will lead the overall Supply Chain quality functions, including incorporation of specifications and requirements, with incoming inspection, issue containment and supplier corrective actions. This role will also support the development and launch of new products.

Interaction with other functional areas:

R&D: Work with R&D personnel to facilitate material and supplier qualification for new product development projects and initiatives.

Purchasing: Ensure suppliers are aligned to meet quality standards and regulatory requirements and to facilitate timely resolution of quality.  Ongoing evaluation and performance monitoring of suppliers.
Quality: Work with Supplier Quality organizations to assure standards are met and executed agreed-to Quality performance/improvement deliverables are completed. Ensure enforcement of contractual commitments by the company to the supplier and the supplier to the company. Manage specifications and incoming inspection and test requirements for materials and components including purchased finished goods.

Responsibilities:

• Conduct supplier evaluation and risk assessments including on-site quality audits as required to ensure conformance to Supplier Quality System requirements.
• Analyze audit results to develop, prioritize and execute corrective actions and supplier development action plans to continually improve supplier performance.
• Lead supplier quality activities that will improve quality of the product and process as measured by internal quality metrics and external quality indicators.
• Provide supplier quality support on NPD and incoming purchased finished goods initiatives.
• Provide support in establishing and implementing standardized quality best practices, processes, procedures within the supply chain and across suppliers.
• Work closely with Suppliers and internal resources to maintain and update supplier performance evaluations, supplier audit procedures and policies, approved supplier listing and supplier risk assessments.
• Oversee inspection of incoming components, finished goods and products from suppliers and manufacturers.
• Conduct periodic material evaluations.
• Work to identify and resolve potential problems and continually improve process for qualification and evaluation of new and existing suppliers, specifications, components, and materials.
• Collaborate with purchasing, manufacturing, quality and R&D to improve overall product quality by emphasizing defect prevention throughout the supplier management process.
• Identify and communicate to Quality leadership issues that impact product quality, safety or efficacy, regulatory compliance or business continuity which have arisen from a supplier.
• Ensure closure of NC’s and CAPA’s, to confirm comprehension, development, and execution of corrective/preventive action with regards to any nonconformity cited.
• Act as the key interface with site operations as it pertains to Supplier Quality Issues.
• Identify areas of opportunity and support continual improvement of product quality.
• Perform other duties as assigned
• Lead quality review for scale up, pilot and stability batch production, including record review and approval during the development process.
• Ensure accurate and timely development of test criteria, product specifications.
• Assist R&D and Operations with the interpretation of Quality requirements, including verification/validation planning and execution, scale-up activities, first or pilot production run requirements and problem resolution.

Basic Qualifications:

• Bachelor degree in science, math or related discipline
• 3-5 years experience in a regulated environment
• 2 years experience in supplier interfacing role
• Knowledge cGMP Guidelines and regulatory requirements.
• Detail oriented, and ability to work with others in a multidisciplinary team environment.
• Ability to travel independently
• Strong time management / project management capabilities
• Strong analytical and written and oral communication skills
• Working knowledge of Process / Manufacturing applications
• Ability to manage a number of projects simultaneously while meeting project milestones and timelines.

Reporting Structure:

This position report to Director of Quality and Technical Services

Email us your resume today to hr@pharmacalway.com