Thermo Fisher Scientific

Director, Quality Purification and Pharma Analytics

Thermo Fisher Scientific • $160K — $240K *
Bedford, MA 01730In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Science, Engineering or related field.
  • 10+ years of experience in Pharmaceuticals or Medical Devices with regulated products.
  • 5+ years managing a multi-site organization.
  • Experience with audit or inspection management (ISO13485, FDA).
  • Customer-facing experience.

Responsibilities

  • Define and align Quality strategy with Group and Corporate goals.
  • Cultivate a robust quality culture throughout the organization.
  • Provide leadership in quality across a multi-site network.
  • Manage cross-functional relationships to ensure product quality.
  • Resolve quality issues and communicate effectively with senior leaders.
  • Apply Quality Risk Management to mitigate failures in product supply.
  • Conduct data analyses for identifying quality improvements.

Benefits

  • National medical, dental, and vision insurance plans with health incentive programs.
  • Employee assistance and family support programs, including tuition reimbursement.
  • At least 120 hours of paid time off (PTO) plus holidays and parental leave.
  • Retirement savings through a competitive 401(k) plan.
  • Employee Stock Purchase Plan (ESPP) for discounted company stock.
Full Job Description
Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

As Director of Quality at Thermo Fisher Scientific, you'll lead strategic quality initiatives that directly impact healthcare and scientific advancement. This role will be responsible for building a customer-focused quality culture and associated quality processes. This includes a dedication to optimizing the customer experience through customer feedback and delivering products that represent industry-leading standards of product quality.

Location

This role is part of the Bioproduction Group within the Purification and Pharma Analytics business unit and is located at the Bedford, Massachusetts PPA site.

What will you do?

  • Define the Quality strategy for the PPA products in alignment with Group and Corporate goals. Ensures adequate deployment and execution of such strategy


  • Drive with intensity a robust quality culture across the organization


  • Provide Quality leadership for the PPA multi-site network.


  • Manage matrix relationships within Thermo Fisher to ensure all product value stream touch points are aligned to deliver Quality products and processes


  • Drive resolution to quality issues as needed and communicates internally to senior leaders and to diverse audiences in an effective manner. Solves problems in complicated situations using analytical skills, creativity, judgment, and technical expertise. Partners with other SMEs as needed


  • Apply Quality Risk Management to prevent risk of failure modes that impact supply of consistent supply of Quality PPA products


  • Conduct advanced data analyses to determine quality problems and to identify larger scale quality improvements. An adequate sense of urgency is expected


  • Participate in cross functional team projects (R&D, Mfg, Vendors, etc).


How will you get here?

Education

  • Bachelor's degree or above in Science, engineering disciplines or similar fields


Experience

  • 10+ years or more experience within the Pharmaceutical or Medical Device Industry - supporting Regulated Products


  • At least 5 years of experience managing/leading a multi-site organization


  • Audit (ISO13485 or similar) or inspection (FDA or similar) management experience


  • Customer facing experience


Knowledge, Skills, Abilities

  • Change agent with experience of driving a robust quality culture


  • Business expertise, understand how quality impacts a business


  • Expert knowledge of Quality Management System design and oversight from a pharmaceutical perspective and/or medical device field


  • Strong communication skills, written and verbal. Experience managing very complex quality issues including escalations within the Company and with Customers. This includes direct verbal interaction, documented communications (email, letters, PowerPoint), and issuing written reports


  • Knowledge of Compliance with quality standards (e.g., 21 CFR Part 820, ISO 13485, 9001)


  • Experience with the use of key quality tools e.g. FMEA, Risk Analysis, RCA and global systems e.g. TrackWise, AGILE, E1/SAP, LIMS or similar


  • Training/understanding in Lean Sigma/Six Sigma processes


Preferred Knowledge, Skills, Abilities

  • Experience within the pharmaceutical and/or biotechnology industry, either in a customer-facing role or as an end-user of bioprocessing technologies; must demonstrate strong understanding of customer quality, regulatory, and operational expectations, and familiarity with purification and/or pharma analytics products and their application in pharma/biotech environments


  • Knowledge of procurement/supplier oversight


  • Experience in project management


  • Understanding of Lean Production System concepts


  • Regulatory Affairs Experience and/or RAPS Certification or ASQ Quality Certifications would be a plus


Compensation and Benefits
The salary range estimated for this position based in Massachusetts is $160,100.00-$240,125.00.

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

About Thermo Fisher Scientific

Thermo Fisher Scientific Careers

Join the vibrant team at Thermo Fisher Scientific, a global leader in serving science and making the world healthier, cleaner, and safer. With a workforce of over 75,000 professionals, Thermo Fisher Scientific offers unparalleled job opportunities and a culture of innovation that propels your career to new heights. Work You’ll Do At Thermo Fisher Scientific, you will be part of a team that is dedicated to enabling our customers to make the world healthier. Whether you are involved in the development of life-saving drugs or innovative environmental solutions, your work will have a profound impact on society. Our commitment to leadership in the industry is unwavering. With Thermo Fisher Scientific, you will lead projects that set standards in scientific inquiry and market leadership. You will work at the intersection of science, technology, and industry expertise, driving digital innovation in every aspect of our business. Join our diverse team of professionals and engage in roles that span across various functions and disciplines. From research and development to marketing and sales, the breadth of job opportunities available means that you can find the perfect match for your skills and passions. Innovative Work As part of our team, you will have access to cutting-edge tools and technologies that foster creativity and innovation. Thermo Fisher Scientific is home to a dynamic range of career paths, all designed to challenge you and help you grow as a professional. Our employment philosophy emphasizes diversity and inclusivity, ensuring that all team members have the opportunity to thrive. We believe in nurturing talent through robust training programs, leadership development, and opportunities for career advancement. Be Part of a Great Team Working at Thermo Fisher Scientific means being part of a global network of enthusiastic, talented, and ambitious individuals. Our culture is built on collaboration, where each member’s unique skills and perspectives are valued. You will enjoy benefits that support both your professional growth and personal well-being. Future-Proof Your Career Embark on a journey of growth and continuous learning with Thermo Fisher Scientific. We offer a variety of training and development programs that cater to your interests and career goals. From internships for budding scientists to leadership training for aspiring executives, our programs are designed to equip you with the skills needed for a successful and fulfilling career. Explore Discover how our commitment to innovation leads to advancements in health and science: [Read More] Learn about our leadership in environmental sustainability and how you can contribute: [Read More] The Thermo Fisher Scientific Difference Our global presence and commitment to innovation mean that your work extends beyond borders and makes a tangible impact worldwide. The collaboration between our teams drives our leadership in the scientific community and contributes to a culture that embraces diversity and fosters professional growth. Stay Connected Join Our Team Search open positions that match your skills and interest. We are always on the lookout for passionate, curious, and driven team players. Explore our job opportunities and find out how you can contribute to our meaningful work. SEARCH THERMO FISHER SCIENTIFIC JOBS Keep Up to Date Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. READ CAREERS BLOG Job Alert Emails Customize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding opportunities that await at Thermo Fisher Scientific.
Learn more about Thermo Fisher Scientific
Size
130,000 employees
Market Cap
$213.3 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.3 billion
Founded
1956
5 Year Trend
+16.5%
Revenue
$32.2 billion
NASDAQ
TMO
* Ladders Estimates

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