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Thermo Fisher Scientific Director, Quality Assurance North America in Lenexa, Kansas

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $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, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 100,000 colleagues 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 .

Group/division summary

The Microbiology Division provides solutions and workflow for food, clinical, and pharmaceutical environments. The markets we serve include food manufactures and labs, clinical and healthcare, pharma and biotech.

POSITION SUMMARY:

The Director of Quality in collaboration with partners ensures that the organization’s products and services are in compliance with the company’s quality system and continuously improves quality and compliance for our customers and regulatory authorities.

You will report directly to the VP of Quality & Regulatory for Microbiology Division, and partner directly with site leaders and business partners at facilities in Lenexa Kansas, Oakwood Village Ohio and Ottawa Canada. You will be an integral part of the North America Leadership team.

Key Responsibilities:

  • Lead a staff of 6 quality leaders (combined staff of approximately 80 quality professionals)

  • You will drive a risk-based approach to decision making with business partners and your teams across the North America site locations.

  • Functions as the Management Representative for your sites to external agencies

  • Reports on the performance of your sites quality system including Quality metrics

  • Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of products, including suppliers and OEM.

  • Reviews and resolves quality challenges / opportunities with Quality Managers, and other functional partners including vendors and customers

  • Coordinates and assists with regulatory and notified body, customer and vendor inspections.

  • Lead all aspects of the internal audit program and supports development of corrective action plans and ensures timely resolution of findings.

  • Provide insight for the business through accurate data analytics.

Qualifications:

  • Bachelor's Degree in Engineering or Sciences. Microbiology is considered a plus.

  • 8+years of professional experience in quality management systems in a regulated environment

  • Prefer medical device/IVD experience

  • Confirmed experience in driving meaningful improvements of quality performance across a broad range of initiatives including development and recruitment of talent, and the elimination of exceptions/SOP standardization.

  • Experience of effectively leading a multi-site Quality leadership team, preferable in a matrix-style organization.

  • Knowledge of global cGMP regulations including FDA, ISO 13485 and other Tier 1 regulatory agencies.

  • Provides reliable / defendable interpretations of standards and regulatory guidance and is capable of defending these positions to regulatory agencies.

  • Productive with a continuous improvement mind-set and disposition

  • Demonstrated eye for business, ability to operate in ambiguity, work under pressure, strong customer orientation, learning agility, within a fast-paced environment

Desired Qualifications:

  • You are skilled in leading a team in a global matrix organization environment.

  • Can effectively handle uncertainty and mitigate risk.

  • You will possess the ability to think strategically, creatively and rationally.

  • You are a strong clear and eloquent communicator (verbal and written) and have good social skills.

  • You have strong planning & organizing skills.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . 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. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

  • This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

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.

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