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Contact Info
Brian Christensen
Life Science

+353 (0)1 685 47 47
brian.c@lifescience.ie
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Details

Director of Quality


Reference:ALPB-442515 Location: Galway
Qualification:MastersExperience:10+ Years
Job Type:PermanentSalary: €100000+
May be suitable for: Qualified Person, QA Manager, QA Director


Based in Galway, this is a key strategic role with our client’s large molecule sterile finished product site

Responsibilities
·The Director of Quality will be responsible for the Quality Operations to ensure that high quality products leaves the site. Working closely with other functions to ensure that a very high standard of quality is maintained and supported by robust systems.
·Direct responsibility for the correct and compliant execution of all aspects of Quality/Quality Management System. Staying abreast of regulatory and compliance developments, communication of such trends and directions to the site
·To support the site’s Qualified Persons as per the relevant EU Directives
·Ensure the manufacture of drug products and finished product are performed in a safe, compliant manner, meeting the relevant regulatory requirements
·Provide strategic and tactical leadership input to the internal operations organization for the manufacture of commercial and development products.
·Direct strategic planning and the development of goals, objectives, and policies for the Quality group in consultation with the Head of Global Injectables Quality Operations, Head of Injectables Site Operations, and the site Leadership Team. Determine group structure; ensure the development of talent for leadership roles; plan talent succession and carry out performance assessments of department sub-ordinates.
·Provide effective Quality leadership during internal and regulatory inspections and to participate in the Internal and External Auditing Program.
·Assure the cross regional systems implementations are integrated and provide the highest level of efficiency. This includes, but is not limited to: Laboratory Process optimization, Operational Excellence compliance level setting and Global Strategic IT implementations (LIMS, TrackWise, Documentum etc.).
·Manage and maintain robust relationships with the internal leadership team, industry colleagues and with the HPRA & FDA organizations.

Requirements
·Must possess knowledge and understanding of worldwide requirements of cGMP and Quality Systems for Commercial and Clinical Injectable products.
·Minimum of a Bachelor's degree (or equivalent) plus 8 years of Quality Management experience in a Pharma or Biologics environment
·QP Status preferred.




Contact Brian Christensen on 01 6854747 or submit your CV to brian.c@lifescience.ie for immediate consideration
If you would like further Information you can contact the recruiter directly:

Brian Christensen | Tel: +353 (0) 1 685 4747