Quality Assurance Leader
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Site de Production Biotech | Biotech Manufacturing Site
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.
An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced…
Quality Assurance Leader
Aseptic Filling, Maintenance/Utilities
…to join our Quality Assurance team.
As Quality Assurance Leader, you will manage and ensure Quality Assurance oversight (on area of responsibilities) for the Neuchatel Site, ensuring compliance with the license, regulations as well as c-GxP Regulations.
You should also act as Qualified Person Delegate as well as back up of other QA Leaders.
In this role, you will also be providing leadership to a quality professional team supporting talent growth as well as linking the people process with a Quality Assurance culture and strategy for the site.
- Ensures development of the Quality Department in alignment with Takeda Quality Culture and Quality Roadmap.
- Owns personal accountability for all EHS Aspects, ensuring his/her team is operating in a safe work place. Understands and applies Takeda EHS guidelines and commitments policy, takes care of his/her own safety as well as of the team, reports at risk situations and improvement opportunities to supervisory personnel
- Ensures positioning of the NE Site in compliance with the License, regulatory expectations, cGMP regulations for current commercial as well as development products. This will be established through close collaboration with his/her main partners heading manufacturing/engineering/supply chain.
- Ensures that all Quality Systems are established and executed on Site. Effectiveness is demonstrated through KPIs and management reviews. Escalation mechanism as defined in Takeda Regulations is being adhered to.
- Executes and supports mechanism for containment, escalation to Management and stakeholders, remediation plans as well as communication to authorities.
- Supports the Recall/complaint process ensuring is managed in-line with Takeda Guidelines
- Ensures efficient Management and Execution of the Change Control Process.
- Ensures right level of GxP Document Control execution and approvals.
- Ensures that deviations are investigated in a timely and qualitative manner.
- Ensures CAPAs to prevent the root-cause from re-occurrence are defined, CAPA effectiveness is assessed and reports are made available.
- Ensures adequate presence of QA on the shop floors and builds strong collaboration with partners.
- Supports inspections conducted by Health Authorities, Customers, and License Partners.
- Ensures that responses to Regulatory and Compliance requests (RA questions and submissions, Observations, Compliance gaps, Audits, etc.) related to his/her team are provided in a timely manner.
- 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)
- Drives continuous improvement and Lean Culture
- Maintains a high level of expertise in current regulatory requirements and technical areas
- Contributes to the Site’s strategic planning and translates into annual Budget.
Education and 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.
- Fluent in English and French
- Strong knowledge of aseptic filling processes as well as sterility assurance.
- Organizational and ability to apply that capability to lead change, deliver strong results and build the confidence as well as trust of stakeholders.
- Ability to effectively lead in a matrix environment.
- 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.
Job ID SR0045821