Our client, a leading pharmaceutical company, is looking for a
QA Project Manager
to lead a team supporting internal and external customers in a GMP environment.
*Please note that we can only consider EU/Schengen applications, or valid Swiss permit.
Your Key Responsibilities:
* Provide daily oversight, tactical and strategic leadership for a team of QA Project Managers.
* Ensure QA Project Managers deliver quality support for:
* Sterility assurance assessments during tech transfer and process validation.
* Material assessments.
* Resolution of tech transfer issues.
* Process validation execution.
* TT production issues, deviations, change controls, regulatory compliance issues, quality agreements.
* Management and tracking of key Performance Indicator metrics.
* Ensure staff meets QA objectives and deliverables on time and in full compliance.
* Train the team and lead identification, defense, and resolution of Quality issues.
* Lead risk assessment and search for compliant solutions.
* Set the model for superior customer service.
* Provide direction, support, and act as escalation point for QA staff and customers.
* Align QA objectives with Quality Agreements, SOPs, and Regulations.
* Develop team goals and drive continuous improvement and innovation.
* Oversee training, mentoring, and development in Quality principles.
* Conduct objective setting and regular feedback sessions.
* Act as QA Project Manager for client projects when required.
* Interview and hire personnel.
* Partner with internal customers for Change Controls, Deviations, CAPAs, and Investigations.
* Support site as senior QA on high-risk changes and deviations across MSAT, Engineering, QC, Validation, SC, and Manufacturing.
* Attend meetings and identify Quality requirements.
* Support QA deliverables for lot disposition, change controls, and deviation root cause analysis.
* Manage and track KPI Quality metrics.
* Represent department at site meetings.
* Prepare deviation trending reports and provide recommendations.
* Support Regulatory and Customer Audits.
Must-Haves:
* BSc/MSc in Science, Biotechnology, or related discipline.
* 10–15 years of advanced-level experience in Quality Assurance.
* 10–15 years of experience managing direct reports.