Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class novel products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmic and Gene Therapy.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people globally affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
About the Role:
This is an exciting and challenging role where you will be responsible for leading all aspects of the Quality Operations at the Neuchâtel facility.
The scope of the role is to ensure that quality systems and all quality related functions are in place and compliant with current Good Manufacturing Practices (cGMP), Shire and other global regulatory standards and requirements.
This person will also manage application of Shire strategic goals and develop Neuchâtel Strategic plan; staffing, organization and development of personnel organization and achievement of defined goals and targets in order to drive the Neuchâtel plant to reach operational excellence.
- Member of the Core and Local Leadership Team.
- Pharmaceutical responsibilities as Qualified Person (delegation).
- Signature delegation of the Qualified Person for the Pharmaceutical responsibility related to Release activities.
Number and position of functional assigned employees: Approx. 140
- Manage all aspects of the Quality Operations at the Neuchâtel facility
- Implement Shire strategy within the area of responsibility (Quality Control & Quality Assurance).
- Maintain and continuously improve quality systems to support national, international and division requirements
- Ensure the Neuchatel site is inspection ready at all time.
- Manage quality process assuring product compliance to applicable regulations and standards
- Supervise and coach managers
- Manage budget including financial improvement (VIPs)
- Regular reporting of key numbers
- Cooperation with other Shire facilities, especially process related facilities (TO, Lessines, Vienna, Singapore)
- Lead and direct the Quality Operations functions.
- Ensure safety, EHS, GMP rules are followed as well as related national and international rules within department.
- Setup PMO´s and projects for team members to achieve daily operations goals as well as strategic quality goals.
- Identify high potential individuals and set appropriate development plans. Support the development and training of team members.
- Motivate and encourage team members.
- Report to VP Quality- Biologics on a routine basis the goals, the achievements, the gaps and the opportunities for improvement.
- Implement and review of the effectiveness of quality systems.
- Build-up and maintain good relationship with operations and other functions (e.g. R&D, RA, Marketing).
- Manage inspections by third parties (e.g. inspections by notified bodies and by regulatory agencies) incl. internal assessments.
- Drive continuous improvement and QLP activity within the area of responsibility. Drive and/or support continuous improvement outside the area of responsibility as defined in the relevant project.
- Regularly review quality and business activities during e.g. Quality Management Review, Business Review, Project Review, CAPA Review and set corrective and preventive measures
- Agrees with acting respectfully and fair towards other people according to Business Ethics Shire Corporation.
Education & Experience:
- Degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent
- Advanced degree in complimentary field of study
- At least 15 years of experience in the biotechnology and/or pharmaceutical industry, preferably both
- Experience leading large teams in a manufacturing environment.
- Experience with large molecule production processes, and aseptic processing,
- Leading a QC laboratory
- Proven people manager and effective leader capable of developing people and teams with at least 10 years of management experience.
- Track record of effective QA leadership for internal production facilities and product disposition.
- Experience leading, training and/or implementing root cause analysis and effective investigation practices
- Strong operations background to ensure value added and effective quality operations. Experience driving out inefficiencies and improving turnaround times
- Understands regulations pertaining to licensing, import/export and transportation requirements.
- Fluent in English and French, other European language is an asset?
Knowledge Skills & Abilities:
- Professional Experience of Releasing pharmaceutical Products (aseptic products, investigational products)
- Excellent knowledge of all global cGxP Regulations
- Understands current pharmacopeia requirements including technical methods (USP, NF, Ph.Eur)
- Sets clear Priorities, manages through KPIs as well as direct supervision,
- Excellent communication Skills with teams, peers, global partners
- Understands the Risk Profile of the Neuchatel Site (with respect to processes, facilities, products, utilities) and is able to provide technical instructions / guidance.
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
- Be Positive
- Be Accountable
- Be Results Oriented
- Be An Excellent Manager of Self and Others