We are looking to fill a new and exciting new role as Quality Assurance Specialist – Vendor Management for a Biotech company who specialises in the development, delivery and commercialisation of Cell and Gene Therapies. This is a rewarding company to work for; they ensure life-changing therapies can be developed for use in health services throughout the world. As the company continues to expand, their QA team need someone who is keen to jump into the role and contribute supporting the team.
This will be working on-site 4 days a week in Essex, with an option to work 1 day a week from home.
We are looking for an eager, hardworking, resilient individual who will ensure that the facility, via proactive engagement, meets the standards and expectations of all key stakeholders, including regulatory authorities and all internal and external stakeholders. The role shall be responsible for supporting the maintenance and continued development of the Quality Management System and monitoring and reporting on the operation of the QMS against agreed key performance indicators.
Key Accountabilities:
Direct report to the Quality Assurance Lead – Document Control and Quality Standards
To work within a multi-disciplinary team to take a leading role in the implementation and establishment of suitable governance processes to assure Vendor compliance.
QA Subject matter expert in relation to new vendor assessment, risk identification, vendor governance, audits, liaison and periodic review
Ownership of the Internal Audit Programme, responsible for oversight, scheduling and process improvements.
Support the supply chain and logistic teams to assure compliance within warehousing, transport and logistical operations
Assist the Quality Assurance Lead – conducting audits to ensure regulatory and Company requirements are met
Vendor Management.
Experience
Experience working with GMP quality systems in a Phase III / commercial pharmaceutical manufacturing of biologicals, vaccines, cell or gene therapies manufacturing facility
Experience working as a quality professional in biologics and preferably cellular and/or gene therapies
Educated to Degree level in a life sciences discipline
Member of the Chartered Quality Institute – Chartered quality professional (desirable)
Knowledge / Skills / Competencies
Highly motivated, pragmatic and practical to support the mission of the Cell Therapy Catapult to accelerate the development of a commercial cell-based therapy industry in the UK
Able to evaluate complex situations and find solutions for them in a professional manner
Project ownership and pride in its delivery
Having a passion for delivering excellent customer service in a cost effective way
Flexibility towards work assignments and new learning