Head of Quality Compliance
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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…
Head Quality Compliance
…to join our Quality leadership team.
As “Head Quality Compliance”, you will ensure the compliance of the Neuchâtel Manufacturing site with global regulations as well as with licenses during routine manufacturing and projects. You will also be responsible for inspection & audit management, as well as supporting the communication for global authorities and provide regular follow up on status of Observation Closure.
Reporting into our local Site Quality Head, you will be a member of the Site Quality Leadership Team and will partner closely with other peers from the Takeda network, to leverage lessons learns as well as ensuring that external Regulatory Intelligence is assessed for applicability and appropriate action is taken in a risk-based approach.
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 compliance business strategy for the site.
Regulatory Inspection Process
- Manage the Site’s Compliance Risk Assessment and ensure integration of a 3-5 years forward looking approach.
- Represents Takeda Neuchâtel during regulatory inspections assuring management that requested information is produced in a timely, accurate and complete manner.
- Manage communication process to the authorities and global functions, especially when reporting on major changes/issues as well as utilizing the escalation process established by Takeda
- Lead a permanent Inspection ready status on site preparing regulatory audits, paper-based inspections, internal inspections, and ensure the corrective actions bring benefit to the site
- Coaches and educates cross functional Takeda staff in regulatory inspection readiness activities.
- Responsible for maintaining site licenses, renewals and paper inspections including holding department owners accountable for timely completion of requests in support of paper inspections.
- Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, as well as the regulations and standards applicable to Neuchâtel.
- Manage and report to corporate quality metrics and KPIs
- Responsible for effectiveness of management reviews (Quality Council) that are being conducted in line with Takeda Guidance.
- Coordinate and monitor complaints responses for products manufactured on site
- Apply Risk Management principles and update the Risk Register
Leadership & Partnership
- Provide leadership and guidance to the Takeda Neuchâtel site to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required are maintained in compliance with applicable regulations, as applicable.
- Provides ongoing development of direct reports
- Establishes strong partnership with key business stakeholders, including Manufacturing Leadership Teams and Department Managers and sister plants to leverage lessons learned
- Recognized as a senior strategic CMC Quality resource. Acts as a quality resource with expertise in regulations relating to cGMP, ICH guidelines, and Operational SOPs.
- Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals.
- Must be able to deal with ambiguity and make decisions under stressful conditions.
- Actively champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation as well as adherence to the principles and values of Takeda-ism.
Education and Experience
- Bachelor’s – Master’s degree in pharmacy, chemistry, biology or a related discipline.
- Profound experience in Quality or related field in the pharmaceutical industry.
- Fluent English and French
- A thorough understanding of pharmaceutical quality management systems relating to clinical and commercial manufacturing, including current GMPs & GDPs.
- Experience in interacting with health authorities including hosting/direct involvement with agency inspections.
- At least 5 years of leadership experience, developing people and strength in managing projects and initiatives
- Experience with Continuous Improvement initiatives
- 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.
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 SR0043070