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Sr. Director, Quality, Drug Product Division

4 months ago

Remote, Oregon, United States Thermo Fisher Scientific Full time

Job Description

Job Description

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 sophisticated 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

Group/Division Summary:

Our Pharma Services Group (PSG) develops and delivers medicines to market that enable our customers to help more than one million patients each day. The Drug Product Division (DPD) is one of the three divisions that make up the Pharma Services Group. We are made up of 10,000+ colleagues across 15 sites who specialize in taking sterile injectable, oral solid dose and softgel drug products from development to commercialization.

Position Summary:

The Sr. Director, Quality North America (NA) Drug Product Division (DPD) is a senior level leadership role responsible for providing outstanding leadership to the Quality organization of the North America Business Unit, comprised of 6 facilities across US and Canada. They will have full direct oversight on all the quality units within the DPD NA network (over 1200 colleagues across a variety of Quality sub functional roles).

The Sr. Director Quality will champion and pursue world class quality, promote a GMP (Good Manufacturing Practice) culture and assure regulatory compliance. Customer engagement is key to the success of DPD NA and requires direct communication so that they are involved in the process, giving them control in exchange for their attention, and to increase brand awareness and loyalty. This role will be also expected to engage and drive customer queries on a Global level, managing escalations accordingly.

The role reports into the Vice President, Quality DPD matrix to the Vice President/General Manager NA, DPD and sits in both the Quality Leadership team of the division and in the North America Leadership Team.

Key Responsibilities:

The Sr. Director Quality will be responsible for the following:

  • Directing Quality operations regionally to support Regional and Business leaders to drive budgeted profit results, establishing objectives and appropriate steps are taken to put preventative actions in place.
  • Candidate will establish, direct, administer and coordinate current and long range objectives and activities in accordance with policies, goals and objectives established by the VP Quality, DPD and DPD NA President.
  • Developing and maintaining positive company image and positive relationships with key customers, vendors and regulators; will personally be involved with the management of key accounts; will represent the company as appropriate in its relationships with external entities.
  • Developing and maintaining a robust divisional quality plan; establishing policies to ensure exceptional management development and provide for capable management succession in Quality.
  • Emphasizing the critical need for on-time delivery through the lens of full compliance; driving this focus across all levels of the organization.
  • Managing all company activities in compliance with quality system regulations as required per (cGMP) standards, and other regulatory entities as appropriate, ensuring division participation and compliance. Ensuring that the division operations comply with all applicable laws and regulations, including OSHA; insuring that all licenses and permits from local authorities, government agencies are obtained and maintained to ensure uninterrupted company operations.
  • Ensuring PPI (Practical Process Improvement) is embraced across the quality organization.
  • Formulating and implementing quality policies, procedures and programs that guide the organization in maintaining and improving its competitive position and the profitability of the operation.
  • Ensure a robust audit mechanism is established globally.
  • Building rapport with workforce to promote quality and safety, ensure productivity and develop high morale.
  • Serve as a Role Model Leader demonstrating strong communication and interactions with colleagues at all levels, promoting positive employee relations.

Qualifications:

  • B.S. Degree in business or a scientific/technical subject area required. Advanced degree such as MBA or Masters a plus.
  • 10+ years' experience leading functional areas to include Quality Assurance, Quality Control and ideally exposure in Production or Distribution.
  • Previous experience in CDMO or Big Pharma with exposure to complex sterile operations is considered mandatory for the role
  • Proven ability to manage multiple priorities and projects in a cross-functional, matrixed environment
  • Ability to translate business demands into an operational quality plan.
  • Ability to quickly create deep connections with customers that drive trust.
  • Advanced understanding and ability to adhere to established quality standards and regulatory compliance requirements highly preferred. Collaboration skills – Able to effectively collaborate with peers in other functions and with colleagues in other businesses or divisions
  • Ability to lead, empower and influence others within a remote team. Highly talented at team building, coaching and mentoring with a passion for inspiring others at all levels of the organization.
  • Track record of achieving results and proven ability to clearly identify and communicate a cogent vision; effectively manage through ambiguity and uncertainty, take appropriate risks and make sound and timely decisions.
  • Embodies our Thermo Fisher values of Integrity, Involvement, Intensity and Innovation.
  • Ability to travel globally as business requires (30% minimum).

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. 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

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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