The Risk Manager at Illumina-Madison will manage the sites risk management portfolio for enzyme manufacturing processes in support of new and on-market Illumina products. The successful candidate will work across the organization to ensure risk assessments are aligned with product and process requirements and controls, as well as maintain compliance with Quality System requirements.
This position requires a seasoned technical leader who has a track record of delivery, excellent communication, the ability to drive alignment thru collaboration, and make decisions in a matrixed organization. Leverage domain expertise to identify, document and mitigate technical risks associated enzyme manufacturing processes (fermentation, homogenization, clarification, chromatography and final formulation). Work with project teams to drive down residual manufacturing risk to acceptable levels. Continually update manufacturing risk files (pFMEAs) to ensure alignment with changes to manufacturing work instructions, active risk mitigations, and current manufacturing practices. Ensure existing manufacturing documentation and process controls are aligned with pFMEAs and product risk (dFMEAs) Work with cross functional teams to ensure V&V plans include risk mitigations commensurate with documented process and/or product risks Identify and prioritize areas of operational risk and facilitate maintaining (and creation of) a Risk Management portfolio. Collaborate with Development, Operations and Quality to develop and deploy prevention-based tools to better monitor risk on the shop floor (i.e. SPC trending). Communicate high-priority mitigation recommendations to Sr. Management and support prioritization against the existing project portfolio. Lead risk assessments for all change requests
5+ years experience in reagent manufacturing (enzyme manufacturing strongly preferred) and/or related process development. Additional 3-5 years working in a Quality Engineering role a plus Demonstrated ability to apply risk-based thinking to develop practical and scalable solutions that serve both business and compliance needs Working knowledge of ISO14971 and/or related risk management practices for IVD and medical device manufacturers. Experience with quality regulations and standards (21 CFR 820, ISO 13485, ISO 14971 preferred). Highly effective communication, facilitation, coaching, and negotiation skills including ability to present and participate in executive presentations. Self-starter, strong work ethic, strong organizational skills, critical thinking. Excellent attention to detail and accuracy, well organized and able to work independently and in teams. Adaptable to fast-paced, dynamic work environment with shifting demands Knowledge and skills typically acquired through previous positions in fast-paced corporate environments which involved responsibility for similar work.
BS/MS/PhD or equivalent in Engineering, Biological/Life Sciences, Chemistry or related field desired.
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