Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmic, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology. In 2016, Shire grew its organization to approximately 24,000 employees+ globally, following integrations of Dyax and Baxalta. An exciting and challenging opportunity has become available at Shire Neuchâtel Plant (approx. 650 employees) for a Quality Manager, within the Quality Assurance Department.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Unit team within a world-class Biotech manufacturing environment.
Job summary The scope of the role is to manage all Quality Assurance aspects for the Neuchatel Site, ensuring compliance with the license, regulations as well as c-GxP Regulations. The job older is expected to act as Qualified Person Delegate.
Essential duties and responsabilities
Contributes to the Site’s strategic planning and translates into annual Budget
Establishes a Workforce Plan for the site QA Organization, provides Leadership to the QA Organization on Site (conducts Compensation reviews, Performance Review Conversations, Setting of Objectives, Development Plans)
Owns personal accountability for all EHS Aspects, ensuring his/her team is operating in a safe work place
Ensures Positioning of the Neuchâtel Site in compliance with the License, regulatory expectations, cGMP regulations for current commercial as well as development products is striving for excellence. This will be established through close collaboration with his main partners heading production, Supply Chain, Laboratories.
Ensures that responses to Regulatory and Compliance requests (RA questions and submissions, Observations, Compliance gaps, Audits, etc.) related to his/her group are provided in a timely manner and with appropriate level of quality
Ensures that all Quality Systems are established and executed on Site within the area of responsibilities. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance. Escalation mechanisms as defined in Site Regulations are being adhered to.
Ensures Efficient Management and Execution of the Change Control Process.
Manages GxP Document Control
Ensures that deviations and complaints are investigated, reports are available
Supervises ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas in the successful performance of these activities.
Drives continuous improvement and Lean Culture
Represents area of responsibility internally and externally
Maintains a high level of expertise in current regulatory requirements and technical areas
Education & Experience
University degree in Life Science
Minimum 8 years of experience in pharmaceutical industry having held positions in Quality.
Qualified Person/delegate experience is a plus, as well as Validation oversight.
Fluent English (C1) and French (min B1) is a must
Full time job, daily working hours Monday-Friday
Living our leadership behaviors is a basic expectation for all Shire employees. Shire expects all employees to embody the following:
Be Results Oriented
Be An Excellent Manager of Self and Others
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