Sr. Manager, Deviation Management (Fully Onsite)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challengesprotecting the environment ensuring food safety and helping find cures for cancer.

Excellent Benefits Package

Review our companys Total Rewards

Medical Dental & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

Location/Division Specific Information

Greenville NC

• 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.

Position Description

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 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.

Key Responsibilities

• Provide strategic leadership for Manufacturing Sciences MSAT and Deviation Management functions ensuring alignment with regulatory requirements business objectives and Thermo Fishers 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

Requirements

• Advanced Degree plus 6 years of experience or Bachelors Degree plus 8 years of experience in pharmaceutical or biotechnology manufacturing with 3 years in leadership roles

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

• 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