Description:

This person will be responsible for the ongoing management of quality performance, and oversight of quality issue resolutions for Suppliers. Primary responsibilities include evaluating and qualifying current and new suppliers, contractors, and consultants based on their ability to meet specified requirements, including regulatory, quality, safety and security requirements.

This position enhances the current process to qualify and audit manufacturers, suppliers and contractors that meet business needs across the organization. This position will assist with the overall Supply Chain quality functions, including supplier corrective actions, root cause analysis, metrics/scorecards and overall supplier quality improvements. This role will also support the development and launch of new products.

Interaction with other functional areas:

Employee will work with R&D personnel to facilitate material and supplier qualification for new product development projects and initiatives.

They will ensure suppliers are aligned to meet quality standards and regulatory requirements and to facilitate timely resolution of quality, including the ongoing evaluation and performance monitoring of suppliers.

Person will also work with production and compounding regarding component and/or raw material defects and communicate with the supplier.

Other Responsibilities:

Conduct supplier evaluation and risk assessments including on-site quality audits to ensure conformance to Supplier Quality System requirements.

Work to identify and resolve potential problems and continually improve the process for qualification and evaluation of new and existing suppliers, specifications, components, and materials.

Analyze audit results to develop, prioritize and execute corrective actions and supplier development action plans to continually improve supplier performance.

Ensure closure of Supplier NCRs and CAPAs, to confirm comprehension, development, and execution of corrective/preventive action regarding any cited nonconformity.

Develop supplier scorecards and metrics to improve quality of the product and process with measurable KPIs

Provide supplier quality support on NPD and incoming purchased finished goods initiatives.

Act as the key interface with site operations as it pertains to Supplier Quality Issues.

Skills:

FDA, GMP, Supplier Quality, Quality Systems

Additional Skills & Qualifications:

Bachelor Degree

3-5 years experience in a regulated environment

3 years experience in Quality

2 years experience in supplier interfacing role

Knowledge of cGMP Guidelines and regulatory requirements.

Strong time management/project management capabilities

Working knowledge of Process / Manufacturing applications

Ability to manage multiple projects simultaneously while meeting project milestones and timelines

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.