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QA Manager

Deeside, Flintshire

ADCBio is an innovative biotechnology company developing new process technology to speed, simplify and significantly lower the production costs of the latest generation of anti-cancer blockbuster drugs, Antibody Drug Conjugates (ADCs). Formed in 2010, ADCBio have recently secured significant investment that is enabling a new dedicated 6500m² facility in Deeside to support the rapid extension plan of the Company.

To support this growth, we are recruiting for a QA Manager, who will be the key decision maker for quality related issues. Reporting to the Head of Quality, you will be responsible for ensuring that ADC Biotechnology Ltd operates in compliance with UK and International GMP Regulations and Guidelines related to the development, manufacture and testing of Antibody Drug Conjugate Drug Substance.

Key Responsibilities will be:

  • Developing, implementing and managing the Quality system and strategy, to ensure it meets the business requirements and customer deliverables.
  • Building and managing the Quality Group through recruiting, selecting, orienting, training, assigning, scheduling, coaching high quality employees.
  • Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements
  • Maintaining MHRA authorisations and coordinating Customer and MHRA audits and inspections
  • Maintaining and improving operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
  • Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being ‘fit for purpose’ operationally and commercially.
  • Ensuring that there is an audit programme in place covering internal and external activities
  • Ensuring appropriate investigation of discrepancies, errors, complaints, failures or adverse events that require documented review and action
  • Maintaining an awareness of new and proposed legislation that impacts the business
  • Develop and deliver training to the organisation
  • Operational responsibility for the manufacturing quality unit to ensure compliance of on-going operations
  • Responsible for supplier management.

 

Qualifications & Skills required are:

  • Educated to degree level – preferably in a scientific discipline.
  • Minimum of 5 years experience in a Quality Assurance role in an MHRA regulated (or equivalent) environment.
  • Minimum of 3 years experience of managing teams with direct line management responsibility.

 

ADCBio offer a generous benefits package including a competitive salary (negotiable depending on experience and qualifications) plus 25 days holiday + statutory (+ death in service and private medical cover following a qualifying period).

Please apply by emailing a copy of your CV along with a covering letter detailing your current remuneration package.

**NO CALLS FROM AGENCIES WILL BE TAKEN IN RELATION TO THIS VACANCY**

Apply Now.