- 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.
- Bachelor's degree in Physical Sciences, Engineering or related field required. PhD in Physical Sciences, Engineering, Pharmaceutics or PharmD desired.
- Ten 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 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.
- 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.).
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Site Quality Head - Bend, United States - Thermo Fisher Scientific
Description
Job DescriptionAs 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.
Location/Division Specific Information
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 Bend Oregon 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.
What will you do?
Education
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 *. 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.
