Director of Quality Assurance - Global Distribution & Logistics.
Frederick, Maryland, United States · On-site
$160k–$240k/yr
Senior+$20B raised
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for…
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Director of Quality Assurance - Global Distribution & Logistics.
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$160k–$240k/yr
Full-time
bachelor degree
Medical Insurance, Dental Insurance, Vision Insurance, Health Incentive Programs, Employee Assistance Program, Family Support Programs
Posted 30d ago
~40 hrs/week
Responsibilities
Lead the Global Distribution Quality Assurance network to establish and implement a Quality Management System for medical devices and IVD products. Drive operational efficiencies through the application of AI and machine learning while ensuring strict cold chain management and regulatory compliance.
Requirements
Requires a Bachelor's degree in Engineering or Science and at least 10 years of experience in regulated medical device or pharma manufacturing. Candidates must have 5+ years of leadership experience and deep knowledge of global quality standards like ISO 13485 and 21 CFR Part 820.
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
How will you make an impact:
Lead the Life Sciences Group, Global Distribution Quality Assurance network in establishing and implementing the Quality Management System (including medical device/IVD regulatory requirements and applicable standards; 21CFR Part 820 QSR, ISO 13485:2016, MDR/IVDR as well as RUO products) supporting the global distribution of products that include strict cold chain management controls.
Further establish and enhance all aspects of the Quality Management System from strategic planning to hands-on implementation on topics such as Distribution Quality Assurance/Control, auditing, document management, CAPA resolution, etc.
Provide strategic Quality leadership in future business growth and in the integration of any new site transfers.
Implement a "Problem Solving" culture to Quality issues that will drive sustainable Root Cause and Corrective Action.
Innovate quality management processes to drive efficiencies in the distribution network through the application of artificial intelligence, machine learning, and other tools to support optimization of resources and minimize product supply disruption and unfavorable customer experiences.
Ensure that the customer perspective is maintained as a priority in the work done every day.
How will you get here:
Education
Bachelor's Degree required, preferred in Engineering or Science
Experience
Minimum of 10 years in a regulated medical device/pharma manufacturing company, including minimum of 5 years leading a quality organization responsible for QA/QC, CAPA, post-market surveillance and all facets of product quality and Production & Distribution controls.
Demonstrate a working understanding of applicable global medical device regulations and standards, (21 CFR Part 820, ISO13485, EU 2017/745 MDR, risk management ISO14971, and other relevant global standards), design control principles.
Champions Quality by Design through the application of Production & Distribution controls, statistical process control, practical process improvement and other tools which support QMS compliance and advancement.
Knowledge of Production & Process controls or Distribution controls. Handling distribution issues impacting licensed medical devices, IVDs, chemicals, controlled substances
Shipping qualification processes including packaging, cold chain management
Knowledge of Risk Managing tools including application of these tools.
Financial acumen including AOP planning
Knowledge, Skills, Abilities
Strong authentic people leadership skills.
Strong Continuous improvement and Problem-solving experience (Lean approach)
Outstanding communication skills with an ability to influence on a global level.
Managerial courage and decisiveness
Adaptable when priorities change
Experience in distribution and transportation preferred
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
Compensation and Benefits
The salary range estimated for this position based in Maryland 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
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
For more information, please visit www.thermofisher.com.
Offices: 168 Third Avenue, Waltham, MA, US
Analytical InstrumentsLaboratory Supply Chain Programs and eCommerceLaboratory EquipmentLab ServicesSpecialty DiagnosticsLife SciencesPharma Servicesand CDMOElectronicsHealth Care
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