Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Benefits:
We offer competitive remuneration, an annual incentive plan bonus, relocation, 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!
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Location/Division Specific Information
The Site Quality Head you will lead the activities of the Quality organization including, Quality Assurance, Quality Compliance, Quality Systems, and Regulatory Affairs of the Bend Oregon facility. This position requires a 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 improving 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 cultivate 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.
- Support the company's PPI (Practical Process Improvement) Business System to build a culture of outstanding performance and continuous improvement.
- Host all Regulatory inspection and liaise and with regulatory bodies such as FDA, EMA, OSHA etc.
- Cultivate a customer focused organization and interact with key clients and provide resolution to customer issues and concerns.
- 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.
Keys to Success:
Education
- Bachelor's degree in Physical Sciences, Engineering or related field required. PhD in Physical Sciences, Engineering, Pharmaceutics or PharmD desired.
Experience
- 10+ years of GMP experience in the pharmaceutical industry.
- 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 change and business development.
- Experience leading testing departments or functions, running large and complex activities and processes.
Knowledge, Skills, Abilities
- Written and spoken communication skills and experience addressing 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 encourage innovation, partnership, visibility, and team effectiveness.
- Ability to solve complex problems, take proactive action, exhibit flexibility, think quickly, and navigate conflict.
- Ability to empower a team, recognize and develop good talent and bring out the best out of each individual.