Jobs in Carmel
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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
- 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
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
Additional preferences are a Master's degree in a relevant field or advanced quality certifications (ASQ, Certified Auditor, etc.) GMP leadership experience of quality professionals is highly beneficial alongside an exposure to aseptic filling operations, sterile manufacturing and parenteral drug products.
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.
Responsibilities: Move vans from Yard to Fulfillment center Clean inside and outside of vans Perform inspection of vehicles both before, and after, operation Read work orders determine work assignments to identify appropriate equipment needs.
Record numbers of units handled and moved, using daily production sheets or work tickets Ensure the yard is clean and organized Assist Delivery Drivers when necessary #CB Capstone Logistics, LLC is part of The Transportation and Logistics industry which has been designated a "Critical Infrastructure Segment".
As a "critical infrastructure industry" worker in the Transportation and Logistics industry, associates are considered exempt from local restrictions such as curfews, shelter-in-place orders, and other mobility restrictions when reporting to, returning from, or performing his or her work functions.
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