QA Manager

Dún Laoghaire, Co Dublin
Contract
Full-time

1 month ago

In support of the clients diverse portfolio, strong pipeline and the patients that we serve, the Quality organization provides end-to-end Quality oversight across a complex and expansive global footprint. Whether it is supplying an early phase clinical trial, manufacturing a commercial product, or distributing product in market, the Quality organization plays an important role to ensure the client provides safe, quality products to patients in a compliant way.External Supply Quality provides Quality oversight to the external manufacturing portfolio across DS, DP and FDP for small and large molecule.Key Responsibilities:

Maintenance of External Supply Quality licenses as it relates to global GMP/GDP activities (MIA, ASR, WDA)
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.
Preparation and periodic review of Bona Fides
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 and champion continuous improvements and initiatives

Authority:

Own Quality record content
Work under minimal direction
Identify opportunities and issues, then determine when escalation is necessary
Proposes revisions to SOPs in area of responsibility

Basic Qualifications:

Doctorate degree OR
Master's degree & 2 years of directly related experience OR
Bachelor's degree & 4 years of directly related experience OR
Associate's degree & 10 years of directly related experience OR
High school diploma / GED & 12 years of directly related experience

Preferred Qualifications:

4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor's Degree in a Science Field
cGMP Experience
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 sites

Morgan McKinley

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