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Director Quality

Thermo Fisher

Director Quality

Thermo Fisher

Fremont, California, USA

·

On-site

·

Full-time

·

2w ago

Compensation

$175,000 - $235,000

Benefits & Perks

Healthcare

401(k)

Equity

Parental Leave

Learning Budget

Commuter Benefits

Healthcare

401k

Equity

Parental Leave

Learning

Commuter

Required Skills

Quality management

Regulatory compliance

cGMP

ISO standards

Risk management

CAPA

Change control

Leadership

Project management

Budget management

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 Director of Quality at Thermo Fisher Scientific, you'll lead strategic quality initiatives that directly impact healthcare and scientific advancement. You'll oversee comprehensive quality systems and operations while fostering a culture of continuous improvement and regulatory compliance. Working with site leadership and cross-functional teams, you'll drive quality excellence across manufacturing, testing, and product development activities. This role offers the opportunity to influence quality standards that ensure the safety and effectiveness of products while partnering with customers and regulatory authorities to maintain the highest levels of compliance.

REQUIREMENTS:

  • Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in FDA-regulated industry (pharmaceutical, medical device, or diagnostics)
  • Preferred Fields of Study: Life Sciences, Engineering, Chemistry, or related scientific/technical field
  • Professional certifications (ASQ, RAPS) advantageous
  • 5+ years of quality management/leadership experience
  • Extensive knowledge of cGMP, ISO standards (9001/13485), and global regulatory requirements
  • Demonstrated success leading quality systems and regulatory inspections
  • Strong expertise in risk management, CAPA, change control, and quality processes
  • Experience managing customer relationships and quality agreements
  • Experience building and developing effective quality teams
  • Strong communication and presentation skills
  • Demonstrated ability to implement organizational change
  • Strong analytical and problem-solving capabilities
  • Project management expertise
  • Strategic planning and budget management experience
  • Up to 30% travel required, including international
  • Experience with quality management software systems
  • Ability to work effectively in matrix environment and across multiple sites

Compensation and Benefits

The salary range estimated for this position based in California is $175,000.00–$235,000.00.

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

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About Thermo Fisher

Thermo Fisher

Thermo Fisher Scientific Inc. is an American life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

10,001+

Employees

Waltham

Headquarters

Reviews

3.9

2 reviews

Work Life Balance

3.5

Compensation

2.5

Culture

3.5

Career

4.0

Management

3.0

65%

Recommend to a Friend

Pros

Large company with extensive resources

Structured internship program

Career opportunities in product management

Cons

Low compensation ($22/hour)

High cost of living in location

Expensive housing/rent

Salary Ranges

2,260 data points

Junior/L3

Mid/L4

Senior/L5

Junior/L3 · Manufacturing Technician

177 reports

$52,776

total / year

Base

$50,360

Stock

-

Bonus

$2,416

$42,159

$66,646

Interview Experience

8 interviews

Difficulty

3.0

/ 5

Duration

14-28 weeks

Offer Rate

12%

Experience

Positive 12%

Neutral 63%

Negative 25%

Interview Process

1

Application Review

2

Recruiter Screen

3

Hiring Manager Interview

4

Panel Interview

5

Final Interview

6

Offer

Common Questions

Technical Knowledge

Behavioral/STAR

Past Experience

Culture Fit

Industry Specific