INCOG BioPharma Services · 2 months ago
Manager of Supplier Quality Assurance
Fishers, IN
Full-time
Onsite
Mid, Senior Level
7+ years expINCOG BioPharma Services is a world-class CDMO focused on parenteral injectable drugs. As the Manager of Supplier Quality Assurance, you will lead the supplier quality program, ensuring compliance with regulatory standards and driving continuous improvement initiatives that impact patient safety and product quality.
BiopharmaBiotechnologyManufacturingPharmaceutical
Responsibilities
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
Develop and execute comprehensive supplier qualification programs, including risk assessments, audits, and ongoing performance monitoring for raw materials, components, and contract services
Maintain robust supplier quality management systems, including vendor approval processes, incoming inspection protocols, and supplier scorecards aligned with GMP requirements
Ensure all supplier quality activities comply with FDA and EMA regulations, ICH guidelines, and other applicable regulatory standards
Plan and conduct comprehensive supplier audits, including pre-qualification, routine surveillance, and for-cause audits, ensuring thorough documentation and effective CAPA follow-up
Identify and implement process improvements to enhance efficiency, reduce cycle times, and strengthen compliance while supporting the organization's rapid growth trajectory
Partner closely with Procurement, Manufacturing, Quality Control, and Regulatory Affairs teams to ensure seamless integration of supplier quality requirements into business operations
Conduct supplier risk assessments, develop mitigation strategies, and manage supply chain disruptions to minimize impact on manufacturing operations
Maintain comprehensive supplier quality documentation, generate performance metrics and reports, and present findings to senior leadership and regulatory inspectors
Evaluate and approve supplier changes, ensuring appropriate risk assessment, validation activities, and regulatory notifications as required
Develop and deliver supplier quality training programs, maintain subject matter expertise, and ensure team competency in evolving regulatory requirements
Qualification
Required
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
Preferred
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
Company
INCOG BioPharma Services
Our services include injectable drug product formulation development, analytical method development, process scale up, and formulation & filling of vials, syringes and cartridges.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
$86.63M2024-05-29Series B· $42.86M
2022-05-10Undisclosed· $15M
2022-05-10Debt Financing
Leadership Team
Tedd Green
Co-founder & Chief Operating Officer
Recent News
Inside INdiana Business
2025-12-16
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