Sr. Manager Quality Sterility Assurance

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

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.

Division/Site Specific Information

Role reports to the Ridgefield, NJ site and reports to the Drug Product Division within the Pharma Services Group.

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.

A Day in the Life:

• 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.

Keys to Success:

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

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 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

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.