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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

**Position** : Senior Quality Manager, North America

**Location** : Remote

When you join Thermo Fisher Scientific, you’ll be part of an exceptionally skilled team where your work will have a real-world impact. Our company is committed to helping customers find cures for cancer, protect the environment, and ensure food safety. This is more than a job; it's a chance to create a difference while achieving your career aspirations.

How will you make an impact?

Assuming the role of Senior Quality Manager, you will be essential in upholding a faultless Quality System that aligns with Site Compliance as per regulatory guidelines. You will take the lead on quality initiatives and collaborate with cross-functional teams to facilitate continuous improvement.

What will you do?

+ Provide Quality oversight to all aspects of the Quality System to ensure site compliance with corporate directives, site procedures, and regulatory expectations

+ Coordinate change control programs, SOP management, document management, and system administration

+ Lead the site Data Integrity program and Computer System Validation

+ Lead digital quality projects in accordance with the site's quality strategy

+ Coordinate training and Personal Quality Initiative programs

+ Develop and implement risk management programs, including communicating risk registers and mitigation strategies to the site Quality Head and SLT

+ Participate in regulatory inspections, Corporate audits, and client audits; develop risk mitigation strategies based on findings

+ Engage with clients to address their questions and concerns regarding site strategy for controlling product quality through quality systems

+ Champion quality initiatives to continuously elevate the quality culture

+ Mentor and coach individuals within the quality department to maintain a focus on quality and compliance

How will you get there?

Education

+ B.S. or equivalent experience in a Scientific or a related field is a must

Experience

+ 10+ years of experience in Quality Assurance, preferably in the Pharmaceutical industry

+ 5+ years of people management experience required

+ ASQ preferred

+ QMS experince perferred

Knowledge, Skills, Abilities

+ Extensive knowledge of related regulatory requirements

+ Outstanding collaboration and communication skills

+ Ability to mentor and influence others effectively

+ Established track record in guiding and controlling quality systems functions to meet regulatory requirements

+ Demonstrated ability to provide compliant and practical solutions to complex product quality issues

+ A strong focus on continuous improvement and client-centric approach

We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, 401k, 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 Indiana is $118,100.00–$177,200.00.

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.