Head of Quality Systems応募 後で応募 求人ID R0009957 掲載日 06/26/2019 Location:Łyszkowice, Poland
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. Learn more at takedajobs.com.
For our Production Plant in Łyszkowice we are looking to hire a new team-member to play a critical role in managing Takeda's growth:
Head of Quality Systems
Establishing and maintaining Quality processes and improving overall site capability. This includes oversight and sustainability of the Global Quality Management System as well as adherence to supplemental local regulatory requirements. Additionally, Head of Quality Systems drives implementation of strategic electronic systems.
- Maintenance and development of Quality Management System (QMS), including implementation of Standards and Procedures;
- Governance and oversight of Quality Risk Management;
- Product Quality Reports (PQRs) preparation;
- Inspection readiness governance;
- GxP learning and training governance;
- Digitization System Implementation governance;
- Data Integrity governance;
- Change Control processes management.
Dimensions and Aspects:
- Knowledge and experience of Bio-Pharmaceutical Research, Development, and Manufacturing;
- Deep knowledge and understanding of relevant regulations (FDA, EMA,SFDA,etc.) enabling effective partnerships across the network;
- Knowledge and understanding of global and local Quality and Regulatory concepts and requirements (e.g. ICH, EUGMP, Annex 1, Compendia, etc.);
- Knowledge and understanding of relevant technologies and digital solutions desired.
- Effective communicator;
- Ability to lead effectively through directing change as well as driving change by influence;
- Ability to act locally as well as engaging to support global activities;
Decision-making and Autonomy
- An active member of Site Quality Leadership team;
- Responsible for decision making that balances progress on global initiatives with local priorities;
- Responsible for active and timely notifications and associated escalation activities in her field of competences.
- Key interactions with all site operating teams;
- Key interface with Global Quality Systems;
- Responsible for supporting the with BOH inspection responses and timely completion of related commitments and CAPA.
- A firm grasp of industry, scientific and regulatory trends, understanding market conditions and leverages innovation to evolve Takeda to become a model for industry;
- Drives innovative electronic solutions in alignment with strategic priorities.
- This role reports locally but engages globally ( Region ) to drive significant progress and sustainable performance of the site QMS and local products;
- The output of this role needs to be appropriately applied to all stages of the product lifecycle.
Education, Behavioral Competencies and Skills:
- Scientific or engineering graduate (BSc, MSc, PhD), preferably complemented by economic education ( MBA) and IT education;
- Steadily increasing managerial experience and responsibility for a minimum 7 years combined with strong technical operations background;
- Experience must include successful examples of managing change by influence;
- Experience in pharmaceutical operations and Quality;
- Strong focus on delivering results as well as building site capability to demonstrate effective governance;
- Extensive global pharmaceutical industry knowledge;
- Fluency in written and spoken English;
- Fluency in Polish.
- Our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – guide how we work and can be felt across every department
- We take actions and make decisions by focusing on patient-centricity; your contribution will make an impact on people’s lives and change futures every day
- We take care about our employees and offer: interesting work in an international environment, the opportunity for self-development, stable employment conditions, benefit package (group insurance, private medical care, co-financing meals in the canteen)
Empowering Our People to Shine
By engaging in our recruitment process you confirm you are aware and you accept Takeda Privacy Notice to Job Applicants. Data Controler is Takeda Pharma Sp. z o.o., Prosta 68, 00-838 Warszawa. You have a right to access your personal data, demand their rectification, erasure, removal, restriction of processing, data portability, as well as to lodge a complaint with a supervisory authority. You may request access to your data or to realize any of the abovementioned rights any time, to the extent specified by law – please contact us as it is described in the Privacy Notice.