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Shire QA Manager in Neuchatel, Switzerland
Takeda 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, Takeda grew its organization to approximately 24,000 employees+ globally, following integrations of Dyax and Baxalta. An exciting and challenging opportunity has become available at Takeda 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
Working Environment: Full time job, daily working hours Monday-Friday
Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.