Senior QC Analytics Manager

KJ101644
  • Negotiable
  • Shannon, Republic of Ireland
  • Full Time

About Your New Employer:

This Employer is a clinical-stage genetic medicine company with a broad pipeline of late-stage clinical programs supported by end-to-end manufacturing capabilities. 

 

About Your New Job as a Senior QC Analytics Manager:

  • Ensure day-to-day management the QC analytical team, ensuring the laboratory is inspection ready and that any data generated is valid an in compliance with applicable internal and external cGMP requirements.
  • Overseeing the Quality Control department to support the quality control release and stability testing of gene therapy products and associated materials.
  • Provide line management to members of the QC analytical team to contribute to the overall group objectives and development of staff.
  • Develop and manage the site testing schedule to ensure testing is complete by the required timelines. 
  • Plan and assign work to the team to achieve the most efficient use of personnel and resources.
  • Responsible for running and maintaining the QC lab(s) to GMP compliance.
  • Manage the stability programme and ensure testing is complete within the required test windows. 
  • Support any incoming material testing to ensure adequate supply of materials.
  • Ensure all quality events (Deviations, CAPA, OOS etc) investigated and closed in timely manner. 
  • Responsible for reviewing all analytical data generated within the QC analytical team 
  • Responsible for organising and reviewing testing with 3rd party collaborators.
  • Support the development, qualification, validation and implementation of analytical methods within QC.
  • Promote appropriate, effective communication within the team, with members of other departments, and with external collaborators.
  • Contribute to cross departmental activities and providing expert advice and technical input where needed.
  • Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.
  • Ensure own and teams KPI’s, plans, targets and objectives are effectively monitored and achieved.

 

What Skills You Need to succeed as a Senior QC Analytics Manager:

  • 7+ years working in a Pharmaceutical/Biotech QC function within a sterile manufacturing site. 
  • Experience of managing a team people within a cGMP QC analytical environment
  • Degree in a relevant scientific discipline element (or equivalent) or relevant experience.
  • Understanding of GMP requirements e.g. legislation, guidelines and requirements related to Gene Therapy, QC method qualification and validation, QC processes, equipment and systems, including Computer System e.g. of EU GMP requirements for Advanced Therapy Medicinal Products, EU/FDA GMP guidelines, EU Annex 1, EU Annex 11 & CFR Part 11 and ICH guidelines Q1-Q10.
  • Good Collaboration, Communication and Conflict resolution skills.
  • Experience in audit inspections.
  • Good technical writing skills.
  • Ability to work in a fast-paced environment essential.

 

What’s on Offer for Candidates for a Senior QC Analytics Manager:

  • Salary of up to 75k
  • Very attractive benefits package
  • Working in a state-of-the-art facility
  • Fantastic development opportunities

What’s Next

  • Apply now by clicking the “Apply Now" button or call me, Karolina on +353 091749267.
  • Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.

 

Karolina Jaglowska Recruitment Consultant, Technical

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