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 the Shire Neuchâtel Plant (approx. 650 employees) for a Quality System Expert.
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 & Regulatory Compliance team within a world-class Biotech manufacturing environment.
The Quality System Expert is responsible for supporting the Quality and Regulatory Compliance group from a Subject Matter Expert (SME) standpoint in accordance with Shire policies, standards, procedures and Global cGMP. The Quality Systems Expert insures that new or modified Quality Systems (deviations, change controls, quality risk management, complaints …) are readily implemented on site and insures that existing systems conform to internal and external quality standards. He/She is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs. He/She provides quality oversight and quality assurance (QA) support to partners (QA, manufacturing, projects). He/She actively participates to internal and external inspections.
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Prepare oral and written communications and communicate problems to management with clarity and accuracy
- Ensures appropriate deployment and coordination with Global and within the site of the Quality Systems
- Acts as Subject Matter Expert of one of the Quality Systems and support the others and he/she monitors his/her quality system performance for emerging trends and search for improvement opportunities.
- Acts as Quality approver as appropriate
- Supports the preparation of the inspections including the pre-requested documentation, and contribute to the definition of the strategy of the observation answers, in their development, and plans for corrective and preventive action, and follow completion of CAPAs
- Participates to the audit team as appropriate
- Supports the regular monitoring and the update of the Compliance Readiness Plan of the site with the different services
- Supports the preparation and the analysis of the indicators related to the compliance activity and proposes improvement actions when indicators show underperformance
- Support Quality Assurance Experts and Quality Product Experts in bringing Compliance support or acts as Quality representative in projects.
- Provides Compliance coaching and training to partners
- Delivers training for which he/she is in charge,
- Participates to the deployment of the QMS simplification/integration
- Bachelor level degree in life technology fields (i.e. biotechnology, (bio)chemistry, engineering); advanced degree preferred
- 5+ years experience with at least 3 years with cGMP manufacturing, Quality, and Compliance and demonstrated use of Quality tools/methodologies
- Ability to understand aseptic manufacturing processes
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects (project management).
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- French and English level C1 or higher are a must
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