Quality Compliance Lead
|Contact Name:||Laurentina Kennedy|
The Quality Compliance Lead will lead and coordinate all activities related to inspections of external Biologics locations and support for inspections at the CMOs and CTLs.
The Quality Compliance Lead will be responsible for hosting inspections and identification and involvement of co-hosts and SMEs depending on the scope of the inspection. The Quality Compliance Lead will be responsible for maintaining site licenses and site master files and will be responsible for the Quality Council for Biologics external supply.
Responsible for hosting external Biologics inspections at external supply locations and identifying co-hosts according to the inspection scope.
Responsible for inspection readiness activities at CMOs and CTLs, including reporting and escalating inspection risks along with the development and execution of actions focused on risk mitigation.
This includes identification of interim controls and influencing stakeholders to drive timely action where mitigation is required.
Maintains and demonstrates inspection readiness and partners with compliance to drive improvement to the inspection programs in alignment with Centre Function and CMOS/CTLs.
Responsible for maintaining site licenses, renewals and inspection documentation
Responsible for the Site Master Files including working with responsible groups to complete updates following procedural requirements.
Manage the Quality Council for external supply
Responsible for inspection responses within defined regulatory timelines and generation of the associated CAPA plans
Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
Demonstrated knowledge in biologic and aseptic manufacturing, systems and process technologies with strong regulatory and cGMP background for drug substance and drug product manufacturing.
This role requires a significant wide spectrum understanding of pharmaceutical manufacturing and the associated requirements. You will be required to work cross-functionally and engage with internal and external stakeholders.
Education, Behavioural Competencies
A Degree in a scientific/technical discipline
Minimum 8 years’ experience in Q Systems/Compliance in Biologics/sterile manufacturing environment and industry managerial experience within manufacturing/Quality.
8 years’ plus experience in leading and managing highly effective technical, manufacturing or Quality teams and developing people in Q Systems or compliance teams.
Experience in a multinational organisation effectively navigating differing regional expectations and regulations
Experience interfacing with regulatory bodies
Recognise the importance of meeting patient, compliance and business needs
For further information on this The Quality Compliance Lead position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie.
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