Site Quality Head

2 weeks ago

Ottawa, Canada Thermo Fisher Scientific Full time

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 e

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