Operations Assurance Partner

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Takeda is committed to fostering a diverse and inclusive workplace, valuing the unique backgrounds and perspectives of our employees. We proudly support our Takeda Resource Groups (TRG), employee-led networks promoting dialogue and professional growth. We encourage all candidates, regardless of background, to apply and explore opportunities to contribute to and benefit from our TRGs and inclusive initiatives. We are dedicated to providing accommodations and support during the recruitment process.
Within the Business Operations department, the Operations Assurance Partner will be responsible for the management of the Quality Management System (QMS) for non-GXP processes in the UK & IE MCO. They will also provide support for training allocation activities for employees via the LMS/DMS and internal/external audit activities as and when required.
This is an 18-month fixed term contract.
KEY ACCOUNTABILITIES

• Ensure the maintenance of the Takeda UK and Ireland Quality Management System (QMS) for non-GXP processes and provide expert opinion to ensure compliance with Global and Local Quality principles, standards, policies and SOPs.
• Provide expert guidance to business owners in developing and implementing new or updated SOPs.
• Create and maintain an annual audit schedule for non-GxP vendors in collaboration with Ethics & Compliance and Quality departments, and support vendors audits management per local SOPs.
• Create and/or maintain any report or tracker required by the Business related to Operations Assurance activities (e.g. QMS/SOP/CAPA trackers...)
• Promote a quality mindset across the MCO by supporting employees in understanding and applying Operations Assurance processes
• Champion continuous improvement and identify opportunities to streamline Operations Assurance activities to increase efficiency using a risk-based approach.

Secondary responsibilities:

• Support the other OAP in managing the Global Electronic Document/Learning Management Systems for non-GXP SOPs as required by the Business
• Support the other OAP in managing the training allocation to all UK and IE MCO personnel via the e-learning systems according to Local and Global standards if required

REQUIRED QUALIFICATIONS

• BSc in a scientific discipline, or
• A-Levels with a minimum 3 year relevant experience

Experience

• Minimum 3 years relevant experience in managing QMS activities in the pharmaceutical industry

Skills / Attributes

• Strong planning skills with the ability to manage conflicting priorities
• Strong interpersonal skills, building successful relationships with key stakeholders internally and externally to drive results.
• Effective written and verbal communication
• Demonstrated ability to assess the internal and external environment to recommend appropriate risk taking.
• Good Excel / reporting skills and Business Process literacy

Empowering our people to shine
At Takeda, we earn the trust of society and our customers through our values of Takeda-ism: Integrity, Fairness, Honesty, Perseverance. We incorporate these values in everything we do. They represent who we are and how we act. They help us make decisions that we can be proud of today and in the future. We enable our employees to develop their full potential.
As a global top employer, we offer exciting career paths, promote innovation, and strive for top performance in everything we do. Takeda fosters an inclusive, collaborative, and international work environment where our teams are united by their relentless commitment to our goal of improving people's health and creating a better future for the world.
Diversity, Equality, and Inclusion
Takeda is committed to foster diversity, equality, and inclusion. Hiring decisions are based entirely on qualifications and are made regardless of gender, ethnic origin, religion, sexual orientation, age, or disability.
If you are interested in this opportunity, we look forward to receiving your application via our online tool!
Learn more at takedajobs.com
Locations
London, Great Britain
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time