The Lead Deviation Investigator is responsible for overseeing, conducting, and documenting investigations related to deviations, nonconformances, and quality events. This role ensures timely, thorough, and compliant investigations that identify true root causes and drive effective corrective and preventive actions (CAPA). The role requires strong analytical skills, technical writing expertise, and the ability to collaborate across cross functional teams.
Key Responsibilities
- Lead end to end investigations for deviations and quality events.
- Gather and analyze data, interview personnel, and review documentation to understand event details.
- Apply structured root cause analysis methodologies (e.g., Causal Factor, 5 Whys, Fishbone, Fault Tree,).
- Ensure investigations are completed within required timelines and meet regulatory and internal quality standards.
- Identify true root causes supported by evidence.
- Develop effective CAPA plans that address root causes and prevent recurrence.
- Partner with process owners to ensure CAPA implementation, effectiveness checks, and closure.
- Prepare clear, concise, and compliant investigation reports.
- Ensure documentation meets GMP, and regulatory expectations.
- Maintain high standards of accuracy, clarity, and traceability.
- Work closely with Operations, Quality Assurance, Engineering, Maintenance, and other departments.
- Facilitate investigation meetings and lead cross functional problem solving sessions.
Requirements
Required Knowledge & Skills
- Strong understanding of GMP, GDP, and regulatory expectations.
- Expertise in root cause analysis tools and structured problem solving.
- Proficiency in CAPA development, implementation, and effectiveness evaluation.
- Excellent technical writing and documentation skills.
- Ability to interpret data, trends, and process performance indicators.
- Strong communication, facilitation, and interpersonal skills.
- Ability to manage multiple investigations simultaneously and prioritize effectively
Preferred Qualifications
- Experience in pharmaceutical, biotech, medical device, or other regulated manufacturing environments.
- Familiarity with electronic quality systems (TrackWise, Veeva, etc.).
- Background in engineering, life sciences, or a related technical field. Experience leading Deviation Investigation
Benefits
- Contract position with possible extension
Top Skills
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
