Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice
Job DescriptionTitle: Manager - CAPA Effectiveness (Deviations)Division/Site Specific InformationYou'll be based at our Greenville, North Carolina location, where you'll have the opportunity to work in a dynamic environment that fosters innovation and collaboration. You will support our Drug Product Division at Thermo Fisher Scientific and play an important role in our company's success.
Discover Impactful Work:The Manager - CAPA Effectiveness provides strategic leadership for the site's CAPA Effectiveness Program, ensuring corrective and preventive actions resulting from deviations, investigations, complaints, audits, inspections, and quality risk assessments effectively address root causes and prevent recurrence. This role partners across Manufacturing, Quality, Engineering, Validation, Supply Chain, and Technical Operations to strengthen the Quality Management System (QMS), drive continuous improvement, and ensure compliance with global regulatory requirements and company quality standards.
A Day in the Life:Key ResponsibilitiesCAPA Program Leadership- Lead and continuously improve the site's CAPA Effectiveness Program for deviations and quality events.
- Establish standardized, risk-based methodologies for CAPA development, implementation, effectiveness verification, and closure.
- Ensure CAPA effectiveness criteria are measurable, scientifically justified, and aligned with regulatory expectations.
- Drive consistent CAPA execution across manufacturing and quality systems.
Investigations & Root Cause Analysis- Partner with investigators to ensure CAPAs address true root causes and provide sustainable solutions.
- Review investigations for technical accuracy, root cause quality, and effectiveness of proposed actions.
- Coach teams on root cause analysis methodologies, including 5 Whys, Fishbone, Fault Tree, Kepner-Tregoe, and Human Performance tools.
- Challenge ineffective or administrative CAPAs and drive robust corrective actions before approval.
CAPA Effectiveness & Trending- Develop risk-based effectiveness verification strategies using quantitative and qualitative performance measures.
- Evaluate effectiveness evidence and recommend CAPA closure, extension, escalation, or additional actions.
- Trend repeat deviations, recurring root causes, ineffective CAPAs, and quality system performance to identify systemic issues.
- Analyze recurring quality events across products, processes, equipment, and manufacturing areas to identify common failure modes and recommend preventive actions.
- Lead cross-functional reviews of recurring issues and drive sustainable process improvements to eliminate repeat occurrences.
- Monitor CAPA and deviation metrics to proactively identify emerging risks and continuous improvement opportunities.
Quality Systems & Regulatory Compliance- Ensure CAPA processes comply with FDA 21 CFR Parts 210/211, EU GMP, ICH Q9, ICH Q10, and corporate quality standards.
- Support internal audits, customer audits, and regulatory inspections.
- Serve as the site subject matter expert for CAPA Effectiveness during regulatory inspections.
Metrics & Continuous ImprovementDevelop and report quality metrics, including:- CAPA effectiveness rate
- Repeat deviation rate
- Recurring root cause trends
- CAPA closure cycle time
- Overdue CAPAs and effectiveness checks
- Investigation quality and root cause accuracy
- Systemic CAPA and recurrence trends
Leverage data analytics to identify emerging risks, recurring failure patterns, and opportunities for preventive actions and continuous improvement.Keys to Success: Education- Bachelor's degree required. Preferably in Life Sciences, Engineering, Pharmacy, Chemistry, Microbiology, or related discipline.
Experience- 5-8 years of pharmaceutical, biotechnology, or medical device manufacturing experience.
- 3+ years of leadership experience in Quality Assurance or Quality Systems.
- Extensive experience managing deviations, investigations, CAPAs, and GMP quality systems.
Preferred Qualifications- Experience supporting FDA and international regulatory inspections.
- Experience with eQMS platforms (TrackWise, Veeva Quality, MasterControl, or equivalent).
Knowledge, Skills & Abilities- Expert knowledge of deviation investigations, CAPA management, and Quality Risk Management (ICH Q9/Q10).
- Expertise in root cause analysis and effectiveness verification.
- Strong analytical, problem-solving, and data analysis skills with experience identifying trends and systemic quality issues.
- Ability to interpret quality metrics and translate data into proactive CAPAs and continuous improvement initiatives.
- Excellent communication, project management, and cross-functional leadership skills.
- Ability to influence without direct authority in a fast-paced GMP manufacturing environment.
BenefitsWe offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
