QA Manager

Global Biotechnology company based in Dublin, Ireland – looking for QA Manager.

The successful candidate will provide Quality oversight to company external manufacturing portfolio across DS, DP and FDP for small and large molecule. Candidate will provide the maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA).

Onsite Requirements - mostly remote. Onsite presence at ADL required once a month (maximum once a week, primarily during on-boarding, relationship building, and team meetings)

The Job:


* Ensuring the review, and where appropriate, preparation and regular update of Quality Agreements with outsourced partners.
* Owner and approver of GMP/GDP QMS documents.
* Support the annual Quality Management Review meeting and co-ordination of any actions from this meeting for implementation.
* QA approval of deviations/non-conformances ensuring deviations are fully investigated and that remedial measures are implemented to address the root cause of failures and relevant actions are taken to prevent their re-occurrence.
* QA approval of change control proposals (third party contractors and internal) and action plans.
* Coordinate mock recall task force team to test the recall process in accordance with governing procedures and issuance of report with recommendations and corrective action plans for any deficiencies identified.
* Support OPEX programs.

Have You:


* 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
* Bachelor’s Degree in a Science Field.
* Ability to oversee multiple projects simultaneously.
* Able to successfully manage workload to timelines.
* Familiarity with basic project management tools.
* Ability to negotiate a position after taking feedback from multiple sources.
* Demonstrated ability to consistently deliver on-time, and high-quality results.
* Ability to operate in a matrixed or team environment.
* Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes).
* Ability to travel +/- 10% of time to domestic and international company sites.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com