Site Quality Head Whitby

2 months ago

Whitby, Canada Thermo Fisher Scientific Full time

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

**Summary**:
**Essential Functions**:

- As a member of the Site Leadership team (SLT) provides overall direction and guidance to the Quality organization.
- Ensures the site aligns with all company policies, standards and all applicable cGMP regulations and requirements applicable to the sites pharmaceutical manufacturing. Provides systems to maintain compliance with these requirements.
- Sets strategy and direction for Quality organization in quality and compliance matters in alignment with Thermo Fisher’s vision and goals.
- Ensures efficient operation of the Quality Control laboratory to support client expectations, project deliverables and financial objectives.
- Ensures all elements of the people plan are carried out including hiring, on-boarding, developing and coaching staff and succession planning.
- Supports the company’s PPI (Practical Process Improvement) Business System to create a culture of exceptional performance and continuous improvement.
- Hosts all Regulatory inspection and liaises with regulatory bodies such as FDA, EMA, etc.
- Represents the company in quality, compliance, and safety matters.
- Partners with SLT to establish and champion Quality Culture.
- Cultivates a customer focused organization.
- Advises executive management on quality issues that may affect the site or the Company as a whole.
- Establishes and reports Quality important metrics to monitor the business and respond to underperformance. Leads a culture of continuous improvement.
- Provides technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups.
- Interacts with key clients and provides resolution to customer issues and concerns.
- Identifies work behaviors, to ensure an accurate succession plan, to serve as a role model in alignment with Thermo Fisher Scientific values.
- Ensures that quality is an integral part of any decision process performed by the site management
- Identifies, develops, and retains qualified people to lead the implementation of integrated quality processes. Runs an efficient and effective Quality CMO organization by collaborating with other department heads at site level
- Plans, handles, and prioritizes the Quality budget and allocate workload and resources (system, equipment, FTEs) to meet compliance and business requirements
- Influences the decision related to skills, labor, and capital across the Site CMO business, needed to drive sustainable compliance.
- Proactively share internally and with other sites in the Thermo Fisher network standard processes, lesson learned. Establishes operational objectives and assists in developing, modifying, and driving company policies that may have company-wide effect. Erroneous decisions or failure to achieve results will add to costs and may impact the short-term goals of the company.
- Guides’ staff to achieve tactical and strategic business goals; responsible for results including costing, methods, and staffing.

**REQUIRED QUALIFICATIONS**

**Education**:
Minimum Bachelor’s degree in Physical Sciences such as Chemistry, Biochemistry, or Pharmacy

**Experience**:
Minimum 15 years of GMP experience in the pharmaceutical industry.

Minimum 5 years experience at Senior Management Quality with multiple direct reports.

**Equivalency**:
Equivalent combinations of education, training, and relevant work experience may be considered.

**Knowledge, Skills and Abilities**:
Extensive knowledge of cGMPs and pharmaceutical manufacturing, Quality Control and Quality Assurance. Experience leading teams through transformational change. Advanced written and spoken communication skills. Able to coach and lead staff in crisis situations and through long term cultural change and business development. Advanced presentation skills, at a level to make presentations to senior executive/board level. Ability to build and lead effective teams. Ability to drive functional, technical and operational excellence. Ability to inspire and foster innovation, collaboration, transparency and team effectiveness. Ability to solve complex problems. Experience managing testing departments or testing functions, managing large and complex activities and processes. Flexible with the ability to and work under pressure. Proactive, strong-minded, quick thinker and assertive. Able to motivate a team, recognize good talent and bring out the best out of each individual. A mature and professional individual who is self-motivated and enthusiastic. Excellent communicator, influencing skills and negotiation skills to get management agreement on ideas and concepts. Able to communicate with all levels of mana

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