Quality Product Lead

ThermoFisher Scientific; Plainville (MA); On-site; USD 104,000 - 156,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Stock purchase plan

Job summary

Thermo Fisher Scientific is seeking a Quality Product Lead to provide technical leadership for GMP manufacturing environments, ensuring quality, compliance, and continuous improvement.

In this role, you’ll partner with customers from batch startup through disposition, manage investigations and CAPAs, and help drive regulatory readiness while maintaining data integrity and strong documentation practices.

Qualifications

• Advanced degree plus 4+ years in GMP QA environment.
• Bachelor's degree plus 6+ years in GMP QA environment.
• Industry experience in pharma/biotech is required.
• Certifications such as ASQ CQE/CQA are valued.
• Experience with risk assessment methodologies and root cause analysis.
• Experience hosting regulatory inspections or audits.

Responsibilities

• Conduct risk assessments, lead investigations, manage CAPAs, and ensure regulatory compliance.
• Serve as a key QA representative to customers from batch startup through disposition.
• Communicate quality events, deviations, investigations, and product impact assessments.
• Build strong customer relationships while ensuring quality and compliance expectations.
• Contribute to robust quality systems and continuous improvement initiatives.

Skills

Quality assurance

GMP regulations

Regulatory inspections

Risk assessment

Root cause analysis

Documentation

Project management

Cross-functional collaboration

Data integrity

English fluency

Education

Advanced degree or equivalent

Bachelor's degree in a related field

ASQ CQE / CQA certification

Tools

QMS software

Document control systems

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

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.

Pharma Services |Viral Vectors | 5 Commerce Drive, Plainville, MA |100% Onsite Days

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.

A Day in the Life:

• 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.

Keys to Success:

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

Benefits

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.

Compensation and Benefits

The 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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.