Our client is a global leader in the Biopharmaceutical Sector. They are seeking an experienced quality professional to join their External Manufacturing Management team in west Dublin. Experience in both Drug Substance (DS) and Drug Product (DP) portions of manufacturing are desirable. This is a management role and will have reports. 15-20% international travel is also a requirement
This position is responsible for the management & control of EU/US contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP. This individual will receive assignments in the form of goals.
Responsible for QA Oversight of CMOs, Suppliers, QC Labs.
Responsible for the compliant day to day management of CMOs & resolution of all quality related issues.
Attendance at all weekly/ monthly and quarterly CMO meetings.
Represent management in meetings and cross functional teams.
QA support and management approval of all documentation.
Development & assessment of quality metrics, CMO trending, KPIs and reports. Responsible to recommend actions as a result of such reviews / reports.
Management of critical issues and timely resolution, developing solutions to complex problems.
Proactive monitoring the performance of CMOs & suppliers to ensure that they remain in a state of control & implementing necessary improvements.
Leading, reviewing and approval of deviations, change controls which are related to CMO management.
Manager oversight and approval on all applicable quality systems pertaining to CMO management including but not limited to Deviations, Change Controls, CAPAs.
Management of annual vendor assessments
Leading or supporting CMO / Quality projects
Leading audits (external)
Analysis of CMO management processes, development of quality improvement plans and continuous improvement.
Update and compliant management of CMO TQAs to ensure agreements are current and within date.
Review and approval of CMO Annual Product Quality Reviews
Roll out of training on QA procedures
Support validation activities related to CMO’s/ CTL’s as required
Support investigations into complaints
Support product launches activities associated with CMO’s/CTL’s/ Suppliers
Providing escalation, weekly updates, reports and stats to management as required.
Bachelor’s degree in pharmacy, chemistry, biotechnology or a related discipline.
Extensive experience working in a QA role in the pharmaceutical industry.
DS and DP biologics manufacturing experience
Thorough understanding of quality systems, cGMPs, GDPs.
Experience in sterile biologics manufacturing
Experience in cell culture, fermentation and purification
Contact Brian Christensen on 01 6854747 or submit your CV to firstname.lastname@example.org for immediate consideration
If you would like further Information you can contact the recruiter directly:
Brian Christensen | Tel: +353 (0) 1 685 4747