QA Manager-Dublin Contractor

This is a 12-month initial contract with a strong view to extension.This is a remote work role.

Purpose 

Quality and Compliance Oversight of a contract lab, CMO or raw material SRE. Alignment with CTA / Marketing Application.

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 the company at product-speci?c Regulatory Inspections and/or during Noti?ed 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

• 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

Requirements

• 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 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