Job Description
The QA Manager will work in the QA Operations External Bio Drug Substance & Drug Product. This unit oversees Qualified Person function, contract manufacturing operations, supply chain operations and supplier quality functions performed. The QA Manager will be responsible for the QA management of EU contract manufacturers, suppliers and test labs as applicable. This position will not have direct reports.
Responsibilities:
You will be responsible for the management & control of EU contract manufacturers, suppliers and QC laboratories (as applicable) in compliance with applicable standards of GMP & GDP. You 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 / CTLs & resolution of all quality related issues.
? Leading meetings with external parties and representing in a professional manner.
? Attendance at all weekly/ monthly and quarterly CMO / CTL meetings.
? Represent the Quality Function at BRMs
? Represent management in meetings and cross-functional teams.
? QA support and management approval of all CMO/ CTL / documentation.
? Development & assessment of quality metrics, CMO trending, KPIs and reports. Responsible for recommending 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 CMO's/ CTL & 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 / CTL management.
? Manager oversight and approval on all applicable quality systems pertaining to CMO / CTL management including but not limited to Deviations, Change Controls, CAPAs.
? Management of annual vendor assessments
? Leading or supporting CMO / CTL / Quality projects
? Leading / Supporting audits (external)
? Support internal and regulatory agency inspections.
? Analysis of CMO / CTL management processes development of quality improvement plans and continuous improvement.
? Update and compliant management of CMO / CTL TQAs to ensure agreements are current and within date.
? Review and approval of CMO / CTL 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 status to management as required.
Education & Experience Requirements:
? Minimum Bachelor's degree in pharmacy, chemistry, biology or a related discipline.
? 8 to 12 years' experience working in a QA role in the pharmaceutical industry.
? Thorough understanding of quality systems, cGMPs, GDPs.
? Experience with Aseptic/ Sterile Processing/Tabletting
? Excellent interpersonal skills and professional skills
? Must be flexible and comfortable with ambiguity in a "start-up" environment
? Must be able to prioritise and multitask in an environment with changing priorities.
? Must be able to travel up to 15 %
? Advanced degree
? Project management/ Lean / OE experience
? Experience working with multiple sites/ locations
? Experience working with contract manufacturing
? Experience interfacing with regulatory bodies or working on regulatory submissions
? Lead Auditor
? Experience with pre-filled syringes
For further information on this QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
Follow us on Facebook, Linked-in, twitter