Sr. Manager, Deviation Management (Fully Onsite)

Thermo Fisher Scientific•Greenville, NC

1d•Onsite

About The Position

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges—protecting the environment, ensuring food safety, and helping find cures for cancer. Join our team as a Senior Manager, Deviation Management, where you will provide strategic and operational leadership across Manufacturing and Deviation Management to support excellence in pharmaceutical manufacturing. In this critical leadership role, you will direct technical operations, drive robust quality systems, and ensure effective technology transfer, process validation, deviation management, and continuous improvement initiatives in a highly regulated environment. You will serve as a key technical and quality leader, partnering closely with Quality Assurance, Operations, Engineering, Supply Chain, and site leadership to ensure manufacturing processes are scientifically sound, compliant, efficient, and inspection-ready. Your expertise will be instrumental in resolving complex technical and quality challenges, implementing sustainable corrective and preventive actions, and maintaining the highest standards of GMP/GxP compliance. As a senior people leader, you will develop and mentor multidisciplinary teams responsible for manufacturing process development, optimization, technology transfer, and deviation investigations. You will foster a culture of accountability, continuous improvement, and innovation, while ensuring teams are appropriately resourced, capable, and aligned to site and network objectives. In addition, you will act as the site owner for Deviation Management, applying PPI (Practical Process Improvement) methodologies to drive consistency, effectiveness, and cycle-time reduction across deviation investigations. You will establish governance models, performance metrics, and escalation pathways to ensure deviations are managed efficiently, root causes are accurately identified, and recurrence is prevented. Working with customers and internal stakeholders, you will support strategic initiatives that enhance manufacturing capabilities, improve process robustness, and strengthen customer confidence. This role offers the opportunity to make a direct impact on patient care by enabling the reliable and efficient production of life-changing therapeutics.

Requirements

Advanced Degree plus 6 years of experience, or Bachelor’s Degree plus 8 years of experience in pharmaceutical or biotechnology manufacturing, with 3+ years in leadership roles
Extensive knowledge of GMP regulations, FDA requirements, and quality systems
Demonstrated success leading technology transfers, process validation, and manufacturing process optimization
Strong experience in deviation management, root cause analysis, CAPA implementation, and inspection readiness
Proven ability to lead and develop technical and quality teams in a regulated environment
Experience applying PPI, Lean, Six Sigma, or similar continuous improvement methodologies
Strong project management, cross-functional collaboration, and stakeholder engagement skills
Data-driven problem-solving skills with experience analyzing manufacturing and quality KPIs
Excellent communication, technical writing, and documentation skills
Ability to manage complex, multi-site responsibilities; travel required
Demonstrated success building collaborative relationships with customers and internal stakeholders
Must be legally authorized to work in the United States WITHOUT SPONSORSHIP OF ANY KIND NOW OR IN THE FUTURE.
Must be able to pass a comprehensive background check, which includes a drug screen.

Nice To Haves

Preferred fields of study: Engineering, Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline

Responsibilities

Provide strategic leadership for Manufacturing Sciences, MSAT, and Deviation Management functions, ensuring alignment with regulatory requirements, business objectives, and Thermo Fisher’s PPI culture
Lead and oversee technology transfers, process validations, manufacturing process development, and optimization activities across the site and network
Serve as the site owner for the Deviation Management process, with accountability for process design, governance, execution standards, and performance outcomes
Ensure timely initiation, thorough investigation, root cause analysis, escalation, and closure of deviations in alignment with GMP/GxP and regulatory expectations
Establish and maintain site-level deviation governance, including tiered review forums, escalation pathways, and decision-making frameworks for complex or critical issues
Partner cross-functionally with Quality Assurance, Operations, Engineering, Supply Chain, MSAT, and site leadership to resolve complex deviations and drive sustainable corrective and preventive actions
Own and monitor deviation and manufacturing performance metrics, dashboards, and trend analyses to identify systemic risks and improvement opportunities
Apply PPI, Lean, and Six Sigma methodologies to improve investigation quality, reduce deviation cycle time, enhance right-first-time performance, and improve customer satisfaction
Act as a subject matter expert during regulatory inspections, client audits, and internal audits, ensuring inspection readiness and consistent execution of technical and quality processes
Lead, develop, and mentor technical and quality teams, ensuring capability development, succession planning, and strong employee engagement
Drive a culture of innovation, continuous improvement, safety, and operational excellence across manufacturing and quality systems
Manage resource planning (headcount, budget, tools) to support current and future manufacturing science and deviation management needs