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Director Quality

Thermo Fisher Scientific
Posted a month ago, valid for 17 days
Location

Fremont, CA 94536, US

Salary

$80,000 - $96,000 per year

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Contract type

Full Time

Paid Time Off
Life Insurance
Tuition Reimbursement
Employee Assistance

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Sonic Summary

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  • Thermo Fisher Scientific is seeking a Director of Quality to lead strategic quality initiatives that impact healthcare and scientific advancement.
  • The position requires an advanced degree with 6 years of experience or a bachelor's degree with 8 years of experience in an FDA-regulated industry.
  • Candidates should have at least 5 years of quality management experience and extensive knowledge of cGMP, ISO standards, and global regulatory requirements.
  • The salary range for this position in California is estimated to be between $175,000.00 and $235,000.00, with potential for a variable annual bonus.
  • This role may require up to 30% travel and offers a comprehensive benefits package, including health plans, paid time off, and retirement savings programs.

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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