The Site Quality Head will successfully manage and direct the activities of the Quality, and Regulatory organization including, Quality Assurance, Quality Compliance, Quality Systems, Quality Control, Microbiology, Regulatory Affairs departments of the Tilburg 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. The site requires the successful candidate to lead the quality department through long-term transformational change.
Essential Functions :
As a member of the Site Leadership team provide overall direction and guidance to the Quality organization.
Ensure the site complies 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.
Set strategy and direction for Quality organization in alignment with ThermoFisher’s vision and goals.
Ensures efficient operation of the Quality Control laboratory to support client expectations, project deliverable and financial objectives.
Ensure all elements of the people plan are executed including hiring, on-boarding, developing and coaching staff and succession planning.
Lead and 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, etc.
Represents the company in quality, compliance and safety matters.
Partner with SLT to establish and champion Quality Culture.
Cultivate a customer focused organization.
Advises executive management on quality issues that may affect the Company or the Company as a whole.
Establish and report Quality KPIs to monitor the business and respond to underperformance. Lead a culture of continuous improvement.
Provide technical support to pharmaceutical sales, client sales, Pharmaceutical Development Services (PDS), Operations and individual client groups.
Interact with key Patheon clients and provide resolution to customer issues and concerns.
Job Scope :
Establishes operational objectives and assists in developing, modifying and executing 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.
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 with Bachelors degree. Extensive knowledge of cGMPs and pharmecutial manufacturing, Quality Control and Quality Assurance.
Experience leading teams through transformational change.
Equivalent combinations of education, training, and relevant work experience may be considered.
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 manage effective team.
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 buy-in 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.).
Physical Requirements :
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time;
manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time;
visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
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 an exhaustive statement of duties, 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 comply 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.
Please take note that we require a negative drug screen, administered by our third-party vendor, as a condition of employment.