Associate Director, Investigations

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The Associate DIR, Production and Manufacturing Excellence, is primarily responsible for the end-to-end management of deviations, investigations, and CAPAs in support of Technical Operations and leading a team with the same scope of responsibilities. Additionally, this role will have responsibility for leading Manufacturing Excellence which encompasses operational performance measures, production systems governance, quality-system execution, continuous improvement, operational readiness, and manufacturing capability development. This role ensures robust, compliant, and inspection-ready execution of deviations, investigations, and CAPAs while advancing operational excellence through standardized production systems, performance metrics, and cross-functional projects and programs. The position serves as a member of the Manufacturing Leadership Team, driving alignment, performance, and continuous improvement across Manufacturing, site-based Technical Operations, and Quality. 

Core Lab & Ops: This role typically requires that the majority of the work be conducted on-site.

1. Ensure consistent, timely, and inspection-ready execution of quality records across Manufacturing, MSAT, Facilities, Engineering, and Supply Chain.   
2. Establish and oversee the strategy, governance, and performance of TechOps quality systems (e.g., deviations, CAPAs, change controls), driving accountability for delivery on key quality metrics and continuous improvement of investigation effectiveness, timeliness, and compliance. 
3. Build and enhance partnership with key stakeholder groups such as Quality and MSAT supporting multiple sites including external manufacturing to share best practices and drive continuous improvement 
4. Lead preparation for regulatory inspections and represent Technical Operations during health authority interactions for quality systems records.  
5. Provide strategic oversight and technical leadership for complex manufacturing investigations and root cause analysis 
6. Define and govern production systems frameworks, standardizing workflows and escalation pathways across Manufacturing, MSAT, QA, and QC 
7. Drive system-level improvements to enhance process robustness and reduce recurrence of deviations 
8. Lead implementation operational excellence initiatives using Lean Manufacturing, Six Sigma, and structured problem-solving methodologies 
9. Contribute to developing strategy and governance for Manufacturing Excellence encompassing: 
10. Reliable execution of manufacturing schedules 
11. Strong right-first-time performance 
12. Operational readiness 
13. Consistent adherence to procedures and business processes 
14. Build, develop, and lead a high-performing team while fostering a culture of accountability, collaboration, and continuous improvement 

1. Bachelor’s degree in science, engineering, or related field required  
2. 10+ years of experience in biopharmaceutical, biotechnology, or gene therapy manufacturing and 7+ years of management experience.  
3. Demonstrated success leading investigations, CAPA systems, and regulatory inspections or interactions  
4. Deep knowledge of GMP regulations and their application in biologics or gene therapy manufacturing  
5. Proven experience driving operational excellence, continuous improvement, and large-scale process transformation  
6. Strong leadership capability with experience building and developing high-performing teams in Manufacturing, Technical Operations, and/or Quality.  
7. Expertise in root cause analysis and structured problem-solving methodologies (e.g., 5 Whys, Fishbone, Is/Is Not)  
8. Experience with electronic quality systems (e.g., Veeva Vault) preferred 

Physical Demand Requirements

Non-Manufacturing or Lab Job:  

1. Stand for extended periods of time with periodic stooping / bending / kneeling 
2. Able to lift, push, pull up to 50lbs. 
3. Climb ladders and stairs of various heights. 
4. Work in a lab environment requiring special protective clothing over the head, face, hands, feet, and body. This role requires the ability to wear personal protective equipment. 
5. Certain tasks may require use of a respirator; medical clearance will be required in advance. 

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