Overview
QA Sr. Manager Jobs in Dublin, County Dublin, Ireland at Berkley Group
Title: QA Sr. Manager
Company: Berkley Group
Location: Dublin, County Dublin, Ireland
QA Sr. Manager
Quality and Compliance Oversight of a contract lab, CMO or a raw material SRE. Alignment with CTA / Marketing Application.
Key Responsibilities
Be an integral quality member of a 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 site 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 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
