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 management and peers within the organization. Ability to handle conflict effectively. Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, etc.). Proficiency with the English language.

Standards and Expectations:

Follow all Environmental Health & Safety Policies and Procedures. Work collaboratively with fellow team members, modelling positive team principles and partnering to meet project and departmental objectives. Carry out all duties within strict compliance to quality systems, SOPs, and Good Manufacturing Practice (GMP). Maintain workspace in a clean and orderly fashion. Actively engage in and adhere to departmental systems in order to maintain a smooth and efficient workflow (visual management, scheduling systems, etc.). Be client and patient conscious at all times. Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem solving. Models positive thinking and is open to change, motivating the team to adapt to shifts in priorities and new ways of working. Proactively identify areas for improvement in the execution of procedures. Communicate risks to timelines in a proactive manner. Consistently strives to improve skills and knowledge in related field.

Physical Requirements:

Light physical effort and fatigue. Walks, sits or stands for limited periods. May require occasional equipment operation including keyboard equipment. Lifts light items for limited duration. Typically located in a comfortable indoor area. There may be exposure to mild physical discomfort from factors such as dust, fumes or odours, temperature extremes, loud noise, strong drafts, or bright lights. Use of Personal Protective equipment may be required and may include any of the following: safety glasses, safety shoes, lab coat, gloves, hair net, beard cover, safety apron, respirator on occasionally.

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees