Senior Director, Quality, Bu Biologics

Senior Director, Quality, Bu Biologics

Thermo Fisher Scientific

Senior Director, Quality, Bu Biologics

Details of the offer

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

What will you do?

Assess and progress an unparalleled Quality System within Biologics BU as a key differentiator for the organization.
Optimize the Global Quality Assurance organizational model with the objective of increasing our customer focus 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 KPIs and accountability measures by which performance can be assessed regularly across the Quality Function.
Use scientific judgment to develop solutions, and drive risk analysis and mitigation strategies.
Maintain awareness of all escalated 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 effective relationships with peer GMs, site leads and Biologics functional leaders to ensure sharing of best practices, sound application of strategic goals, leveraging of “expertise,” and alignment for our clients as a global business.
Make connections and maintain relationships across the company to leverage value to our customers.

How will you get here?
Bachelor’s degree in a life science discipline, advanced degree highly preferred.

Minimum of 10 years related progressive experience, to include a minimum of 5 years of people management/direct leadership experience. Understanding of the biologics manufacturing process in GXP environments.
Considerable hands-on experience interacting with health authorities, especially related to regulatory inspections and follow-up.
Experience managing within a matrix environment; demonstrated ability to collaborate and navigate across the globe effectively with solid business results.
Experience working effectively with clients in regulated environments.

Knowledge, Skills, Abilities
Fluent English, both written and oral is crucial.
Strong influencing skills, internally and externally, demonstrated within prior work environments.
Excellent communication skills, ability to build productive relations.
Strong drive 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 mindset.
Demonstrated success in coaching 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.

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 productivity in their laboratories, we are here to support them. Our global team of more than 75,000 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 and Patheon. For more information, please visit .

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