Quality & Regulatory Affairs Compliance Manager
We are seeking an accomplished Quality & Regulatory Affairs Compliance Manager for our global biotechnology client, a well-established organization specializing in research, drug discovery and development, manufacturing and commercialization.
The ideal candidate will have a strong track record of working to GMP standards within a Quality Assurance function, with experience leading teams and managing groups of over 10 reports.
Responsibilities include:
* Developing departmental policies and procedures to ensure regulatory requirements are fulfilled.
* Managing direct reports to ensure Quality Assurance responsibilities are met.
* Providing regulatory training and mentoring to staff.
* Scheduling resources to manage compliance systems and ensure timely completion of audits, inspections, investigations, and reviews.
* Reviewing and endorsing Quality Assurance reports to ensure proper interpretation of regulatory requirements.
* Ensuring records and reports are prepared, communicated, and retained in accordance with applicable regulations.
* Meeting with operations personnel to explain audit findings and consult on corrective actions.
* Representing the corporation during regulatory and client inspections/audits.
* Preparing site/operation personnel for client and regulatory audits.
* Coordinating regulatory and client audit responses.
* Tracking corrective actions and apprising management of their status.
* Assessing vendors and suppliers for compliance with applicable regulatory requirements.
* Participating in Regulatory Affairs and Compliance projects and programs.
* Performing general auditing duties for compliance with quality standards.
* Preparing written reports on audit and inspection activities.
* Reviewing SOPs.
Requirements
* BSc. in a relevant Science discipline.
* Significant track record of working to GMP standards within a Quality Assurance function.
* Established track record of leadership and people management.
* Proven track record as a competent people leader, with experience managing groups of more than 10 reports.
* Good working knowledge of pertinent regulations.
* Demonstrates strong leadership ability, communication, and facilitation skills.
What we offer
* Comprehensive benefits package from day one.
* Global opportunities and strong career progression.
* Flexible hybrid working model.