INCOG BioPharma Services Careers - Manager of Supplier Quality Assurance

INCOG BioPharma•Fishers, IN

63d•Onsite

About The Position

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.

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

Nice To Haves

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

Responsibilities

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