Biotech Network Advisor, Quality Assurance

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Job Posting: Biotech Network Advisor, Quality Assurance  

Position Description: 

The Quality Assurance Advisor reports directly to the Quality Executive Director and supports the Biotech Network Sites for capital project activities and supplier quality. This position will be responsible for supporting the design, engineering, commissioning, and qualification of facilities, utilities, and equipment. The role ensures compliance with the requirements of all relevant regulatory agencies. You will be responsible for advising and assisting in the review of commissioning, qualification, and validation documents supporting capital project execution. The Quality Assurance Advisor will provide leadership and guidance to other Quality staff engaged in capital project and technology transfer activities, and support establishment/continual improvement of local business processes and procedures that align with Elanco operational standards across the Biotech Network.  The role will also provide support to all sites in the network related to materials management and the supplier quality program.  

Your Responsibilities: 

• Act as the Quality Assurance representative in all local and major capital project activities within the Biotech Network. 

• Participate in design, development, execution, commissioning, qualification, and validation activities for major projects. This includes, but is not limited to: definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, and support for process validation. 

• Assist in defining needs for Quality Control testing laboratories and compliance needs of the same. 

• Ensure design and execution of capital projects consider USDA, FDA, and EMA regulatory and quality requirements; provide interpretation of standards and influence/align with local and global business partners to ensure compliant delivery. 

• Act as a QA subject matter expert in project teams and committees. 

• Review, revise, and approve relevant documentation including user requirement specifications, design specifications, DQ, SAT, FAT, IQ, OQ, PQ documents, PFDs, safety and environmental assessments, validation plans/protocols. 

• Support the creation, review, and implementation of quality standards and procedures for new facilities, utilities, equipment, and manufacturing processes. Establish and continually improve local business processes and systems in alignment with Elanco operational standards across the Biotech Network. 

• Support computer system validation activities including review and approval of validation protocols and reports. 

• Partner with R&D, Manufacturing, Engineering, Supply Chain, and TSMS to support the successful technology transfer of new mAb products. 

• Review and approve change management plans and complete/verify corresponding action items. 

• Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and technical success. 

• Provide leadership and guidance to Quality staff (internal and/or external) engaged in capital project and technology transfer activities. 

• Demonstrate strict adherence to relevant local, state, and federal requirements, cGMP standards, and Elanco policies and procedures. Exemplify "Safety First and Quality Always" mind-set. 

• Attend and complete necessary training as required in order to stay current with industry standards. 

• Provide guidance on adherence to requirements related to materials management and supplier quality.  Assist in the development and maintenance of functional standards and procedures. 

Minimum Qualifications: 

• Bachelor's degree in a science or engineering discipline. 

• 10+ years' experience in quality, engineering, or validation roles in a regulated industry. 

• Thorough knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU regulations as related to manufacturing, quality, and release activities. 

• Strong leadership, team building, organizational, and interpersonal skills. High attention to detail. 

• Knowledge and understanding of biopharmaceutical and pharmaceutical operations. 

• Analytical Skills: Highly analytical and strong advocate for process improvement. 

• Excellent written and verbal communication skills with internal and external customers, peers, and managers. 

• Excellent computer, documentation, and organizational skills required. 

• Demonstrated ability to work collaboratively and across multiple departments and organization levels. Experience with Microsoft Office (Microsoft Word, Excel, PowerPoint, and Outlook). 

What will give you a Competitive Edge (Preferred Qualifications): 

• MSc or PhD in Chemistry, Bio/Pharmaceutical Technology, Microbiology, or a related discipline. 

• Management/supervisory experience. 

• Experience in tech transfer, optimization, and validation of analytical methods for characterization of biological products (e.g., mAbs, recombinant proteins, vaccines). 

• Experience in materials management for USDA, FDA, or EMA regulated industries. 

• Experience in operational excellence and root cause investigation procedures. 

• Experience in Quality Control testing and environments. 

• Experience in user specifications and design qualifications. 

• Experience in equipment and facility commissioning, qualification, and validation procedures. 

• Demonstrated success leading cross-functional teams/projects. 

• Experience with SAP, JMP, Veeva Vault. 

• Excellent technical writing skills. 

• Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics. 

• International experience is highly valued. 

Additional Information: 

• This is a full-time, permanent, salaried, on-site position (supporting Biotech Network Sites). 

• Minimal travel requirements (< 30%). 

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