Quality Product Lead

Regulatory Jobs; Plainville (MA); On-site; USD 104,000 - 156,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Paid PTO

401(k) plan

Life insurance

Job summary

Thermo Fisher Scientific in Massachusetts is seeking a Senior Quality Specialist to lead regulatory-compliant quality programs across GMP operations. You will guide investigations, CAPAs, risk assessments, and documentation to uphold global standards.

Expertise in FDA/EMA regulations, quality systems, and cross-functional collaboration will drive continuous improvement and customer confidence in our pharmaceutical and biotech initiatives.

Qualifications

• Advanced degree with 6+ years in GMP QA in pharma/biotech preferred.
• Certifications such as ASQ CQE or CQA are valued.
• Strong knowledge of FDA, EMA, and global GMP regulations including 21 CFR Parts 210/211 and ICH guidelines.

Responsibilities

• Lead investigations and manage CAPAs to ensure compliance.
• Oversee risk assessments and change control within GMP environments.
• Collaborate cross-functionally to drive quality improvements and regulatory readiness.

Skills

GMP knowledge

Regulatory inspections

CAPA investigations

Risk assessment

Root cause analysis

Documentation

Project management

Cross-functional collaboration

Quality systems

FDA/EMA knowledge

Quality writing

English proficiency

Education

Advanced Degree

Bachelor's Degree

Tools

None

Job description

Work Schedule

First Shift (Days)

Environmental Conditions

Office

Job Description

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: 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 a Senior Quality Specialist, you'll provide technical leadership and oversight for GMP manufacturing environments, working cross-functionally to drive quality excellence and continuous improvement. You'll serve as a subject matter expert, conducting risk assessments, leading investigations, managing CAPAs, and ensuring adherence to global regulatory requirements. 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.

REQUIREMENTS

• Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience within quality assurance in GMP-regulated pharmaceutical/biotech environment preferred.
• Professional certifications valued (e.g. ASQ CQE, CQA)
• 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
• Experience with risk assessment methodologies and root cause analysis
• 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
• Experience hosting regulatory inspections and customer audits preferred
• 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

Benefits

We offer competitive remuneration, annual incentive plan bonus, 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!

Other

Relocation assistance is not provided.

Must be legally authorized to work in the United States now and in the future, without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Compensation and Benefits

The salary range estimated for this position based in Massachusetts is $104,100.00–$156,100.00.

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