Manager, Product & Client Quality

Regulatory Toolkit; Ridgefield (NJ); On-site; USD 114,000 - 170,000; Full time

Benefits offered by this job

Medical and dental plans

Vision plan

PTO 120 hours + holidays

Parental leave

Commuter benefits

Tuition reimbursement

401(k) plan

Employee stock purchase plan

Job summary

Thermo Fisher Scientific in New Jersey is seeking a Quality Manager to oversee our quality management system and drive regulatory compliance and patient safety. You will guide CAPAs, manage APQRs and management reviews, and collaborate with Manufacturing, Regulatory Affairs, and Supply Chain to resolve quality issues and foster continuous improvement.

This role requires a Bachelor's degree plus 4–5 years in quality within pharma/medical devices, ISO 9001/13485 knowledge, and ability to mentor

Qualifications

• Bachelor's Degree with 4-5 years of quality experience in pharma, medical devices, or regulated industry.
• Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP).
• Experience supporting internal/external audits and regulatory inspections.
• Demonstrated ability to develop and mentor quality teams.
• Proven track record implementing and improving quality systems.

Responsibilities

• Plan and deliver Annual Product Quality Reviews (APRs) on schedule.
• Coordinate management review presentations with subject matter experts.
• Author and manage reports, decisions, and actions from APQRs and reviews.
• Support site Change controls, CAPAs and Deviations as needed.
• Support site Quality Plan and track KPIs & metrics with stakeholders.
• Lead QMS improvements and cross-functional process optimization.

Skills

CAPA

Risk analysis

FMEA

Root cause analysis

Auditing

Education

Bachelor's Degree in a scientific/technical field

Tools

TrackWise

Document Control Systems

Job description

Work Schedule

Standard (Mon-Fri)

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: 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.

RESPONSIBILITIES

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 elevate 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

Compensation and Benefits

The 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