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.
A challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 620 employees) for a Quality Supervisor, 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.
The scope of the role is to manage a Quality team overseeing raw materials, warehousing and distribution spects for the Neuchatel Site, ensuring compliance with the license, regulations as well as c-GxP Regulations.
Essential duties and responsibilities
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 NE 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/her 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 adequate presence on the shop floors and builds strong collaboration with partners.
Supports inspections conducted by Health Authorities, Customers, and License Partners.
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.
Ensures that deviations and complaints are investigated in a timely and effective manner.
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 Sciences
Minimum 3-5 years of experience in pharmaceutical industry having held positions in Quality.
Qualified Person/delegate experience is a plus.
Fluent French and English is a must
Full time job, daily working hours Monday-Friday
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.