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QA Risk Management Sr Engineer Summary

This is an exciting opportunity to build and lead the quality risk management program at a growing, world-class CDMO specializing in sterile injectable drug products and combination product assembly. As a member of the Technical Systems team within Quality Assurance, you will serve as the site subject matter expert (SME) for quality risk management, partnering across Manufacturing, Engineering, Validation, Quality, and Project Management to embed risk-based thinking into every facet of our operations. If you thrive on creating foundational programs from the ground up and want to make a meaningful impact on patient safety, this role is for you.

Reporting to the QA Manager of Technical Systems, the QA Risk Management Sr Engineer is responsible for developing and implementing corporate quality risk management policies, procedures, and tools in compliance with ICH Q9, ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and applicable EU regulations. This role will establish and maintain the site risk register, provide SME oversight of risk assessments across deviations, change controls, engineering projects, validation activities, medical device and combination product operations, manufacturing processes, and continuous improvement initiatives. The QA Risk Management Sr Engineer will prepare risk management reports and metrics for Quality System Management Review and serve as the QA representative ensuring risk-based decision-making is consistently applied across the organization.

Essential Job Functions:

• Develop, implement, and maintain corporate quality risk management policies, procedures, and work instructions in alignment with ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and EU GMP Annex 20
• Establish and manage the site-wide Quality Risk Register, ensuring risks are identified, evaluated, controlled, reviewed, and communicated in a timely manner
• Serve as the QA subject matter expert (SME) for quality risk management, providing oversight and guidance on risk assessments (FMEA, FTA, HACCP, PHA, and other ICH Q9 tools) across all site functions
• Provide QA risk management oversight for deviations, investigations, CAPAs, and change controls, ensuring risk-based rationale is documented and defensible
• Support and oversee risk assessments associated with engineering projects, facility and equipment qualification, and validation lifecycle activities
• Provide QA risk management oversight for medical device and combination product (autoinjector, prefilled syringe, and similar device) assembly operations, ensuring compliance with ISO 13485 and ISO 14971 requirements
• Author and manage risk management files for combination products and device assembly processes as required by 21 CFR Part 820 and ISO 14971
• Prepare and present quality risk management metrics, trending data, and summary reports for Quality System Management Review meetings
• Partner with cross-functional teams including Manufacturing, Engineering, Technical Services, Supply Chain, Validation, and Project Management to embed risk-based thinking into daily operations and continuous improvement initiatives
• Facilitate and lead risk assessment workshops, training sessions, and coaching for site personnel on quality risk management principles and tools
• Support regulatory inspections and client audits as the risk management SME, including preparation of risk-related documentation and responses
• Monitor and evaluate changes in regulatory guidance, industry standards, and best practices related to quality risk management and recommend updates to site practices accordingly
• Ensure integration of risk management activities with the site Contamination Control Strategy (CCS) and overall Quality Management System (QMS)

Special Job Requirements:

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or a related scientific discipline; advanced degree preferred
• Minimum of 7 years of experience in quality assurance, quality risk management, or a related function within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment
• Demonstrated experience developing and implementing quality risk management programs, including authoring risk management policies, SOPs, and risk assessment tools
• Strong working knowledge of ICH Q9(R1), ISO 14971, ISO 13485, 21 CFR Parts 201, 211, and 820, and EU GMP Annex 20
• Hands-on experience with formal risk assessment methodologies including FMEA, FTA, HACCP, and Preliminary Hazard Analysis (PHA)
• Experience in aseptic/sterile injectable drug product manufacturing or parenteral fill-finish operations
• Excellent written and verbal communication skills with the ability to present risk information clearly to technical and executive audiences

Additional Preferences:

• Experience with combination product (drug-device) risk management and familiarity with autoinjector or prefilled syringe device assembly processes
• ASQ Certified Quality Engineer (CQE), Certified Reliability Engineer (CRE), or equivalent professional certification, ISO 13485 or related certifications
• Experience establishing a site risk register and integrating risk management outputs into Quality System Management Review
• Prior experience at a contract development and manufacturing organization (CDMO)
• Working knowledge of EU GMP Annex 1 (2022) Contamination Control Strategy requirements and integration of risk management into CCS
• Experience supporting FDA, EMA, and/or client regulatory inspections and audits as a risk management subject matter expert
• Familiarity with ISPE risk management guidance, PDA Technical Reports, and ASTM E2500 as applied to pharmaceutical and medical device manufacturing

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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