New · posted Nov 15
Thermo Fisher Scientific · Pharmaceuticals
Senior Manager Quality Sterility Assurance
- Ridgefield, NJ
- On-site
- Full-time
- Manager
The role
Title: Senior Manager Quality Sterility Assurance
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.
Discover Impactful Work
As a Senior Manager of Quality at Thermo Fisher Scientific, you will guide strategic quality initiatives and support a culture of continuous improvement across our organization. You'll oversee quality management systems, ensure regulatory compliance, and enhance customer experience through excellent quality standards. Working closely with cross-functional teams, you'll develop and implement quality strategies that support our mission of enabling customers to make the world healthier, cleaner, and safer.
What you need
Education/Experience
- Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in pharmaceutical, medical device, or regulated life sciences industry required.
- Preferred Fields of Study: Science, Engineering, Chemistry, or related technical field
- Professional certifications desired (ASQ, Lean Six Sigma, etc.)
- 5+ years of quality management/leadership experience
- Experience hosting regulatory inspections and customer audits
- Experience implementing continuous improvement initiatives
- Experience with quality tools including FMEA, Risk Analysis, and Root Cause Analysis
Knowledge, Skills, Abilities
- Expert knowledge of global quality standards (ISO 13485, ISO 9001, FDA 21 CFR 820, EU MDR/IVDR)
- Strong understanding of quality management systems and GMP requirements
- Demonstrated experience leading quality investigations, CAPA, and change control processes
- Excellent project management and cross-functional leadership abilities
- Strong data analysis and problem-solving capabilities
- Excellent written and verbal communication skills
- Ability to build collaborative relationships at all levels
- Proficiency with quality management software systems
What you'll do
- In this role, you'll manage quality assurance and quality control teams while building strong partnerships with operations, R&D, commercial teams, and customers.
- You'll guide process improvements through Practical Process Improvement (PPI) methodologies and risk-based approaches.
- Your leadership will be essential in maintaining inspection readiness, managing customer relationships, and ensuring compliance with global regulatory requirements.
- As a member of the Quality Leadership Team, you'll support quality initiatives that deliver consistent product excellence while meeting business objectives.
- You'll develop quality professionals, lead investigations, and implement data-driven solutions that enhance our quality systems and customer satisfaction.
Pay
$143,200 – $214,900 a year
Employer providedThe salary range estimated for this position based in New Jersey is $143,200.00–$214,900.00.
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
We 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.
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
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Division/Site Specific Information
Role reports to the Ridgefield, NJ site and reports to the Drug Product Division within the Pharma Services Group.
Job intelligence
The context around this role
Live data · November 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 52% above the US median for Microbiology & Sterility Assurance roles at this level.
This roleEmployer provided
Manager roles in the US7 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $143,200 | — | $214,900 |
| All US (middle half) | $108,500 | $117,500 | $129,250 |
This role: Thermo Fisher Scientific's own published range. Comparisons: the base pay employers published on open Microbiology & Sterility Assurance roles at the same level on Regulatory Jobs, November 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Microbiology & Sterility Assurance
The general path across 54 open Microbiology & Sterility 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 22 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership10
- Quality systems and risk7
- GMP and compliance5
- Investigations and CAPA3
- Lab testing and methods1
- Regulatory submissions1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Microbiology & Sterility 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
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- 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
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDAFDA OOS guidance(official source, opens in a new tab)Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
Company hiring pulse
Thermo Fisher on Regulatory Jobs
- 111
- Open roles
- 111
- Distinct roles
- 50
- Locations
By discipline
- Quality72 62%
- Clinical38 33%
- Regulatory6 5%
By level
- Senior & Principal60 52%
- Associate & Specialist29 25%
- Manager21 18%
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Senior Manager Quality Sterility Assurance at Thermo Fisher
Open until filled. $143K–$215K a year, employer provided.