New · posted Nov 11
Thermo Fisher Scientific · Pharmaceuticals
Manager, Product & Client Quality
- Ridgefield, NJ
- On-site
- Full-time
- Manager
The role
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.
DESCRIPTION:
As a Quality Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services. This role offers the opportunity to make a meaningful impact by protecting patient safety, supporting innovative research, and enabling critical scientific discoveries.
What you need
What you'll do
Product Quality and Management Reviews
- Strategically plan and prioritize Annual Product Quality Reviews (APRs) to meet assigned timelines.
- Coordinate and compile management review presentations with subject matter experts. (weekly and monthly meetings as needed)
- Author and manage reports, decisions, and action items arising from APQRs and management reviews.
- Support site Change controls, CAPAs and Deviations as needed.
- Support site Quality Plan and track KPIs & metrics with applicable stakeholders.
- Lead Quality Management System improvements and cross-functional process optimization, including but not limited to implementation and optimization QMS systems.
Client Quality Relations
- Serve as the primary Quality representative for assigned clients.
- Coordinate client-related quality commitments and action items, track progress, and escalate overdue or significant quality issues through established processes. (CCRs, Deviations, Complaints, Batch Release etc.)
- Monitor product quality trends, risks, and key performance metrics.
- Support client quality meetings, audits, and requests for quality information as assigned.
- Partner with Manufacturing, Quality, Regulatory Affairs, and Supply Chain to drive issue resolution and continuous improvement.
- Represent Quality during Business Reviews, Supplier Operations Meetings, and strategic customer engagements as needed.
- Serve as the bridge between customers and internal stakeholders to ensure alignment on quality expectations and product performance.
Quality Culture
- Participate site's Quality Culture Program and promote Quality Culture across site.
REQUIREMENTS:
• Bachelor's Degree plus 4-5 years of experience in quality experience in pharmaceutical, medical device or regulated industry
• Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
• Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP)
• Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)
• Experience supporting internal/external audits and regulatory inspections
• Demonstrated ability to develop and mentor quality teams
• Successful experience implementing and improving quality systems
• Skill in cross-functional collaboration and stakeholder management
• Strong analytical and problem-solving capabilities
• Clear written and verbal communication skills
• Proficiency with quality management software (TrackWise, Document Control Systems)
• Experience with continuous improvement methodologies (Lean, Six Sigma)
• Ability to promote quality culture across all levels
• Focus on customer needs and ability to manage customer/supplier relationships
• Up to 20% travel may be required
Pay and benefits
$113,600 – $170,300 a year
Employer providedThe salary range estimated for this position based in New Jersey is $113,600.00–$170,300.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Medical, dental and vision plans
Paid time off and 10 paid holidays
Paid parental leave
401(k) retirement plan
Employee Stock Purchase Plan
Tuition reimbursement
Where you'll work
Ridgefield, NJOn-siteOpen in Maps (opens in a new tab)
More jobs in Ridgefield, NJSchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in New Jersey6 roles publishing pay
Manager roles in the US58 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $113,600 | — | $170,300 |
| New Jersey (middle half) | $108,500 | $130,500 | $141,250 |
| All US (middle half) | $116,375 | $143,750 | $163,250 |
This role: Thermo Fisher Scientific's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 340 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Thermo Fisher's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 18 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Quality systems and risk8
- Collaboration and leadership8
- GMP and compliance3
- Investigations and CAPA3
- Documentation and SOPs2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirementsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 117
- Open roles
- 117
- Distinct roles
- 52
- Locations
By discipline
- Quality76 62%
- Clinical40 33%
- Regulatory6 5%
By level
- Senior & Principal58 48%
- Associate & Specialist32 26%
- Manager26 21%
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Manager, Product & Client Quality at Thermo Fisher
Open until filled. $114K–$170K a year, employer provided.