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Thermo Fisher Scientific Sr. Directory, Quality, Global Biologis (Remote) in St. Louis, Missouri

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 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 sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them.

Key Responsibilities

  • Assess and progress an unparalleled Quality System within Biologics Global Business Unit (BU) as a key differentiator for the organization.

  • Optimize the Global Quality Assurance organizational model with the objective of growing our customer centricity and value; aligning roles and responsibilities.

  • Translate Drug Substance Division strategy to programs and goals for the function; ensure execution and delivery of such programs.

  • Collaborate with Operational and Functional peers to formulate short and long-term quality objectives for the Biologics BU; establish critical metrics and accountability measures by which performance can be assessed regularly across the Quality Function.

  • Maintain awareness of all raised Quality matters and exercise sound, risk-based decision making in resolving these issues, working closely with GMs, QA leaders, Legal and Business Relationship Management teams when concerns arise.

  • Ensure appropriate and efficient systems are in place for investigation and follow-up of non-conformances and quality issues, such as complaints, deviations, OOS results, or audit observations; ensure timely closure of any corrective and preventative actions.

  • Accountable for the development, maintenance and management of quality systems that conform to applicable cGMP regulations.

  • Coach and guide the Quality teams to ensure that the above activities are implemented and aligned across the business globally.

  • Maintain influential relationships with clients and suppliers.

  • Establish deep relationships with peer GMs, site leads and Biologics functional leaders to ensure sharing of standard methodologies, sound application of strategic goals, improving of “expertise,” and alignment for our clients as a global business.

Minimum Requirements/Qualifications

  • Bachelor’s degree in a life science field, advanced degree highly preferred.

  • Minimum of 15 years related multidimensional experience, to include a minimum of 10 years of people management/direct leadership experience. Understanding of the biologics manufacturing process in GXP environments.

  • Proficient English, both written and oral is crucial.

  • Considerable hands-on experience interacting with health authorities, especially related to regulatory inspections and follow-up.

  • Experience leading within a matrix environment; proven track record to collaborate and navigate across the globe efficiently with shown business results.

  • Strong influencing skills, internally and externally, shown within prior work environments.

  • Experience working effectively with clients in regulated environments.

  • Excellent interpersonal skills, ability to build productive relations.

  • Strong strive to challenge thus improve processes continuously.

  • Strong problem-solving skills and the ability to make timely, risk-based decisions.

  • Focus on patient needs and a client-centric approach.

  • Shown success in mentor teams through internal and external challenges, preferably in a matrixed culture.

  • Multi-cultural exposure and understanding; experience to work in and with global teams.

  • Ability to travel based on business needs up to 50%, international and domestic travel.

Our distributed team of more than 90,000 colleagues delivers an outstanding 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 and Patheon. For more information, please visit www.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.

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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