New · posted Nov 12
Thermo Fisher Scientific · Biotechnology
Quality Product Lead
- Plainville, MA
- On-site
- Full-time
- Senior & Principal
The role
Title: Quality Product Lead
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 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
Join our quality team at Thermo Fisher Scientific, where you'll make a meaningful impact ensuring product quality and regulatory compliance across our pharmaceutical and scientific operations. As Quality Product Lead, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement.
What you need
Education/Experience
- Advanced Degree plus 4 years of experience, or Bachelor's Degree plus 6years of experience in quality assurance in GMP-regulated pharmaceutical/biotech environment required.
- Preferred Fields of Study: Chemistry, Biology, Microbiology, Engineering, or similar scientific, engineering or related technical field.
- Professional certifications valued (e.g. ASQ CQE, CQA).
- Experience with risk assessment methodologies and root cause analysis.
- Experience hosting regulatory inspections and customer audits preferred.
Knowledge, Skills, Abilities
- Strong knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211, ICH guidelines
- Proven expertise in quality systems including investigations, CAPAs, change control, document control
- Proficiency with quality management systems and standard office software
- Strong technical writing and documentation skills
- Excellent verbal/written communication and interpersonal abilities
- Demonstrated project management and organizational capabilities
- Strong analytical and problem-solving skills
- Ability to work independently and collaborate effectively in cross-functional teams
- Data integrity and computer system validation experience preferred
- Ability to work effectively with diverse teams
- Customer-focused mindset with strong attention to detail
- Fluency in English required; additional languages valued
What you'll do
- You'll serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements.
- As a key client-facing representative of Quality Assurance, you will partner directly with customers from batch startup through disposition, providing timely communication regarding quality events, deviations, investigations, product impact assessments, and other quality-related matters that may affect manufacturing operations, product release, or disposition timelines.
- Through proactive engagement and transparent communication, you will help build strong customer relationships while ensuring quality and compliance expectations are consistently met.
- This role offers the opportunity to directly contribute to our mission of enabling customers to make the world healthier, cleaner and safer through robust quality systems and processes.
Pay
$104,100 – $156,150 a year
Employer providedThe salary range estimated for this position based in Massachusetts is $104,100.00–$156,150.00.
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
Plainville, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Plainville, MASchedule and working conditions
Days
Standard (Mon-Fri)
Environmental Conditions
Office
Location/Division Specific Information
Thermo Fisher Scientific - Viral Vector Services (VVS) is a multifaceted gene therapy contract development and manufacturing organization (CDMO) that seeks sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization for our client partners and the patients we serve.
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
This role's midpoint is 10% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in the US64 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $104,100 | — | $156,150 |
| All US (middle half) | $93,375 | $118,000 | $150,000 |
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 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 336 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 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership7
- Quality systems and risk6
- GMP and compliance5
- Investigations and CAPA4
- Lab testing and methods3
- Documentation and SOPs2
- Data and digital systems2
- Validation and qualification1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Assurance work in biotechnology, 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
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and AnswersNamed 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 quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- 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
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- 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 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
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
- 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
- 114
- Open roles
- 114
- Distinct roles
- 52
- Locations
By discipline
- Quality76 64%
- Clinical37 31%
- Regulatory6 5%
By level
- Senior & Principal60 50%
- Associate & Specialist28 24%
- Manager25 21%
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Quality Product Lead at Thermo Fisher
Open until filled. $104K–$156K a year, employer provided.