What are the responsibilities and job description for the Manager Supplier Quality Assurance position at Lead Candidate?
Manager Supplier Quality Assurance
WHO?
INCOG Biopharma Services in Indianapolis, IN is looking for a Manager Supplier Quality Assurance who will be at the forefront of expanding their supplier quality program and leading supplier quality management for all types of biologic drugs for their clients. This individual will shape quality systems, develop a high-performing team, and drive continuous improvement initiatives that directly impact patient safety and product quality. This role offers the opportunity to join INCOG's state-of-art CDMO during an exciting time of growth, contributing towards a better path to market for life-saving drugs.
WHAT?
- 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
- Training & Knowledge Management: Develop and deliver supplier quality training programs, maintain subject matter expertise, and ensure team competency in evolving regulatory requirements
YOU!
Ideally, candidates will have a Bachelor's degree in Life Sciences, Chemistry, Engineering or a related field. You will also have 7 years of 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
WHY INCOG?
- Paid time off, based on tenure
- 11 paid holidays
- 401(k) plan with company match up, vested immediately
- Choice of health & wellness plans
- FSA and HSA options
- Onsite wellness facility
- Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations
Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…
Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.