The Role:
PE Global are recruiting for a QA Sr. Manager to be based in Dun Laoghaire
12 Month initial contract
Description
Quality and Compliance Oversight of a contract lab, CMO or a raw material SME. Alignment with CTA / Marketing Application.
Key Responsibilities
* Be an integral quality member of cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain XPD etc.
* Negotiator and Approver of quality agreements.
* Lead the preparation of the site for and represent at product-specific Regulatory Inspections and/or during Notified Body audits of CM Site, as applicable or required.
* Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas.
* Review / Approve Master Batch Records.
* Quality approver for deviations, change controls, CAPA.
* Prepare inspection playbooks.
* Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management.
* Perform Person in Plant activities as required.
* APR Data Provider.
* Manage Audit commitments to completion.
* Perform tactical batch disposition activities in support of lot release.
Authority
* Decision to release or reject batches (Dynamic is different for SREs).
* Decision to approve or reject deviations, Change Control, CAPA.
* Decision to approve QAGR.
* Provide Quality position on GMP related topics and strategy for the site.
* Decision to approve Master batch Records/Raw Material Specifications.
Basic Qualifications:
* Doctorate degree & 2 years of directly related experience OR
* Master’s degree & 4 years of directly related experience OR
* Bachelor’s degree & 6 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:
* 10 + years biotech or pharmaceutical industry experience.
* Additional European Languages – desirable not essential.
* Significant Quality experience at Aseptic Manufacturing facilities.
* Able to facilitate and influence senior stakeholders and partners.
* Able to successfully manage workload and timelines.
* Familiarity with basic project management tools.
* Ability to negotiate a strategic position after taking feedback from multiple sources.
* Strong project management, problem-solving, and analytical skills.
* Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results.
* Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution.
* Ability to operate in a matrixed or team environment with site, functional, and executive leadership.
* Experience driving decision making by using DAI principles.
* Experience with the “variation management” process.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Audrey Mccarthy on +353 21 4297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net
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