Manager of Supplier Quality Assurance

Description

As Manager of Supplier Quality Assurance, you'll be at the forefront of expanding our supplier quality program and leading supplier quality management for all types of biologic drugs for our clients. This is a unique opportunity to shape quality systems, develop a high-performing team, and drive continuous improvement initiatives that directly impact patient safety and product quality. You'll work alongside passionate professionals in a collaborative environment where innovation meets rigorous GMP standards, and where your expertise will be valued and your career growth accelerated.

This role encompasses comprehensive responsibility for all aspects of supplier quality assurance, including vendor qualification and management, incoming material inspection programs, supplier auditing, and CAPA management. You'll lead the development and implementation of robust quality systems that ensure compliance with FDA, EMA, and other regulatory requirements while supporting our rapidly growing aseptic filling operations. The successful candidate will build and mentor a team of quality professionals, drive process improvements for enhanced efficiency, and establish strategic partnerships with key suppliers to ensure consistent delivery of high-quality materials and services.

Essential Job Functions:

• Team Leadership & Development: Build, lead, and mentor a team of supplier quality professionals, establishing clear performance objectives, providing ongoing coaching, and fostering a culture of continuous improvement and regulatory compliance
• Supplier Qualification & Management: Develop and execute comprehensive supplier qualification programs, including risk assessments, audits, and ongoing performance monitoring for raw materials, components, and contract services
• Quality Systems Ownership: Maintain robust supplier quality management systems, including vendor approval processes, incoming inspection protocols, and supplier scorecards aligned with GMP requirements
• Regulatory Compliance: Ensure all supplier quality activities comply with FDA and EMA regulations, ICH guidelines, and other applicable regulatory standards
• Supplier Auditing: Plan and conduct comprehensive supplier audits, including pre-qualification, routine surveillance, and for-cause audits, ensuring thorough documentation and effective CAPA follow-up
• Process Improvement: Identify and implement process improvements to enhance efficiency, reduce cycle times, and strengthen compliance while supporting the organization's rapid growth trajectory
• Cross-functional Collaboration: Partner closely with Procurement, Manufacturing, Quality Control, and Regulatory Affairs teams to ensure seamless integration of supplier quality requirements into business operations
• Risk Management: Conduct supplier risk assessments, develop mitigation strategies, and manage supply chain disruptions to minimize impact on manufacturing operations
• Documentation & Reporting: Maintain comprehensive supplier quality documentation, generate performance metrics and reports, and present findings to senior leadership and regulatory inspectors
• Change Control: Evaluate and approve supplier changes, ensuring appropriate risk assessment, validation activities, and regulatory notifications as required
• Training & Knowledge Management: Develop and deliver supplier quality training programs, maintain subject matter expertise, and ensure team competency in evolving regulatory requirements

Special Job Requirements:

Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field

7+ years of experience in pharmaceutical quality assurance with at least 3 years in supplier quality management

Strong knowledge of FDA regulations (21 CFR Parts 210, 211, 600), EMA regulations, ICH guidelines, and GMP requirements related to quality assurance and quality systems

Experience with supplier auditing, qualification, and ongoing management programs

Demonstrated ability to identify improvements to quality systems and to lead implementation of these improvements

Excellent written and verbal communication skills with ability to interact effectively with suppliers and internal stakeholders

Additional Preferences:

Master's degree in relevant field or advanced quality certifications (ASQ, Certified Auditor, etc.)

3+ years of leadership experience managing quality professionals in a GMP environment

Experience in aseptic filling operations, sterile manufacturing, or parenteral drug products

CDMO or contract manufacturing experience

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

By submitting your resume and details, you are declaring that the information is correct and accurate.