Pharmaceutical & Biotechnology

QA Manager – South Dublin

  • Contract
  • South Dublin, County Dublin, Ireland
  • 42038403

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