New · posted Oct 25
Thermo Fisher Scientific · Pharmaceuticals
Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints
- Greenville, NC
- Hybrid
- Full-time
- Manager
The role
Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints
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, like protecting the environment, making sure our food is safe or helping find cures for cancer.
What to expect
- Provide leadership and oversight of the Deviation, CAPA, and Complaints programs, ensuring compliance with cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and applicable quality system requirements.
- Lead and develop a team of quality professionals, providing coaching, performance guidance, and support for professional growth.
- Oversee deviation investigations, root cause analysis, CAPA development, implementation, and effectiveness checks to ensure timely and sustainable resolution of quality issues.
- Monitor quality metrics, identify recurring trends, facilitate governance reviews, and communicate program performance and significant quality concerns to leadership.
- Collaborate with cross-functional stakeholders to resolve quality challenges, improve investigation effectiveness, and drive continuous improvement initiatives.
- Support internal and external audits, client inspections, and regulatory inspections as a subject matter expert for deviation and CAPA management.
- Maintain effective quality documentation, procedures, and electronic quality management system records while supporting training and process improvements.
- Establish priorities, manage competing business needs, and support quality systems across pharmaceutical and medical device products.
What you need
Education
Bachelor's degree in a scientific, engineering, health-related, or closely related technical field.
Experience
- Minimum of 7 years of experience in the pharmaceutical or medical device industry, including investigations, deviation management, CAPA, Quality Assurance, or related quality systems responsibilities.
- Minimum of 5 years of leadership experience with direct reports, including employee development, coaching, and performance management.
- Demonstrated experience overseeing deviation investigations, CAPA implementation, effectiveness checks, and complaints management within a regulated environment.
- Strong understanding of FDA regulatory requirements, cGMP, 21 CFR Part 211, ICH Q9, ICH Q10, and pharmaceutical quality systems.
- Experience using electronic quality management systems such as TrackWise, Veeva Vault, MasterControl, or similar platforms.
- Excellent analytical, investigation, and problem-solving skills with the ability to identify root causes and implement effective corrective actions.
- Strong communication, interpersonal, and stakeholder management skills with the ability to influence and collaborate across organizational levels.
- Proven ability to lead cross-functional initiatives, manage competing priorities, and deliver results within established timelines.
- Experience with quality metrics, trend analysis, risk management, inspection readiness, and continuous improvement.
- Strong organizational skills, attention to detail, and demonstrated ability to develop high-performing teams.
- Experience supporting pharmaceutical manufacturing and medical device quality systems is highly desirable.
- Physical requirements include the ability to work in an office and manufacturing environment, stand or walk for extended periods as needed, and occasionally lift up to 25 lbs.
What you'll do
You will lead a team of approximately 3–4 direct reports responsible for supporting deviation, Corrective and Preventive Action (CAPA), and complaints management programs across the Greenville site.
Your responsibilities will include providing oversight of quality investigations, monitoring program performance, ensuring timely CAPA execution, and identifying opportunities to improve quality processes. You'll work closely with Quality, Manufacturing, Operations, and other cross-functional partners to resolve complex quality issues, maintain inspection readiness, and support effective risk-based decision-making.
As a people leader, you'll coach and develop your team, establish priorities, and foster a collaborative, accountable environment. This role offers broad exposure to multiple client products and portfolios, including expanding medical device operations.
Pay
Thermo Fisher Scientific didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Review our company’s Total Rewards
Medical, Dental, & Vision benefits-effective Day 1
Paid Time Off & Holidays
401K Company Match up to 5%
Tuition Reimbursement – eligible after 90 days!
Employee Referral Bonus
Employee Discount Program
Recognition Program
Charitable Gift Matching
Company Paid Parental Leave
Career Advancement Opportunities
Where you'll work
Greenville, NCHybridOpen in Maps (opens in a new tab)
More jobs in Greenville, NCSchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
Discover Impactful Work
Join our Quality Systems & Compliance leadership team and help shape the future of quality across our growing pharmaceutical and medical device operations.
As a Manager, Quality Systems & Compliance – Deviation/CAPA/Complaints, you will oversee critical quality programs that support regulatory compliance, effective investigations, corrective and preventive actions, and customer complaint management across our expanding business.
This is an opportunity to lead a focused team of quality professionals while collaborating across functions to solve complex challenges, strengthen quality systems, and drive continuous improvement. With continued growth in our medical device portfolio and pharmaceutical manufacturing operations, you'll have the opportunity to expand your leadership capabilities while making a meaningful impact on quality performance and operational excellence.
Location/Division Specific Information
Greenville, NC
Schedule: Monday–Friday, standard business hours | Hybrid flexibility: Work from home one day per week
Job intelligence
The context around this role
Live data · October 25, 2026
Salary intelligence
How the pay compares
Manager roles in the US112 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $130,875 | $153,000 | $167,625 |
Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 25, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 925 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Quality systems and risk10
- Investigations and CAPA9
- GMP and compliance5
- Documentation and SOPs3
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 87
- Open roles
- 74
- Distinct roles
- 35
- Locations
By discipline
- Quality78 90%
- Regulatory7 8%
- Compliance & Safety2 2%
By level
- Senior & Principal34 39%
- Associate & Specialist27 31%
- Manager21 24%
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Manager, Quality Systems & Compliance - Deviation/CAPA/Complaints at Thermo Fisher
Open until filled.