• Job Description

  Req#: TFSCGLOBALR01213251EXTERNALENGLOBAL

  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 and delivering COVID-19 solutions. 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.

  Location/Division Specific Information

  Softgel - High Point, NC USA

  Discover Impactful Work:

  The Site Quality Head will successfully lead the activities of the Quality organization including, Quality Assurance, Quality Compliance, Quality Systems, and Regulatory Affairs of the High Point facility. This position requires an experienced and entrepreneurial leader that will develop Quality strategy, make decisions based upon relevant data and Good Manufacturing Practices (GMPs). This position will hold the site and team responsible for meeting commitments and enhancing customer experience.

  A day in the Life:

  • As a member of the Site Leadership Team (SLT) provide overall direction and guidance to the Quality organization and set strategy in alignment with Thermo Fisher’s vision and goals. Partner with SLT to establish and foster a quality culture.
  • Ensure the site aligns with all company policies, standards and all applicable cGMP regulations and requirements applicable to pharmaceutical manufacturing. Provides systems to maintain compliance with these requirements.
  • Ensure all elements of the people plan are performed including hiring, on-boarding, developing and coaching staff and succession planning.
  • Support the company’s PPI (Practical Process Improvement) Business System to create a culture of exceptional performance and continuous improvement.
  • Host all Regulatory inspection and liaise and with regulatory bodies such as FDA, EMA, OSHA etc.
  • Represent the company in quality and compliance matters.
  • Cultivate a customer focused organization and interact with key Patheon clients and provide resolution to customer issues and concerns.
  • Advises executive management on quality issues that may affect the Company.
  • Establish and report KPIs to monitor the business and respond to underperformance.
  • Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups. Interact with key customers and provide resolution to customer issues and concerns.

  Keys to Success:

  Education

  • BS or higher in chemistry, pharmacy, microbiology or other relevant life science field

  Experience

  • Ten years of GMP experience in the pharmaceutical industry.
  • Oral solid dose and/or Soft Gel pharmaceutical manufacturing experience is preferred
  • Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance.
  • Experience and ability mentoring and leading staff in crisis situations and through long term cultural and transformational change and business development.
  • Experience leading testing departments or functions, running large and complex activities and processes.
  • Equivalent combinations of education, training, and relevant work experience may be considered.

  Knowledge, Skills, Abilities

  • Advanced written and spoken communication skills and experience presenting to senior executive/board level. Effective negotiation skills and ability to influence management to get agreement on ideas and concepts.
  • Ability to drive functional, technical, and operational excellence. Ability to inspire and foster innovation, collaboration, transparency, and team effectiveness.
  • Ability to solve complex problems, take proactive action, exhibit flexibility, think quickly, navigate conflict, and work under pressure
  • Ability to motivate a team, recognize and develop good talent and bring out the best out of each individual.
  • Maintain professionalism, self-motivation, and enthusiasm.
  • Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.).

  Physical Requirements / Work Environment

  (Provide details)

  Benefits

  We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

  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! 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.

• About the company

  Thermo Fisher Scientific is an American provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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