QA Manager – South Dublin

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:

Preferred Requirements:

• 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