Associate Director/Director Quality Assurance

Global Life Science Hub has taken on a fascinating, exclusive retained assignment with a rapidly growing life science organisation that provides unique lab services to a vast range of pharma's, from start-ups to top 10. They are looking to further appoint 230 new allocated positions across the United States in the next 24 months.

Due to this exciting growth stage, they’re now searching for a brand-new seasoned Quality Assurance Manager/Director that will be responsible for assisting the Vice President with ensuring quality processes are maintained. The appointed candidate will also be liable to act as the chief internal regulatory advisor in the Senior Director’s absence and will drive growth in the US and Europe.
Responsibilities

• Leads and directs activities of the Quality and Regulatory Services department
• Performs routine assessment of QRS team members and develops team development plans
• Assesses and responds to issues impacting a wide range of clients
• Advises Senior Management and operations regarding regulatory and corporate compliance and suggest potential avenues for compliance
• Maintains and expands regulatory knowledge, to the ICH Principles of GCP, General Data Privacy Regulation, and International GCPs; provides industry-leading compliance guidance and quality assurance consultation to internal and external stakeholders
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting, and documenting gap analyses
• Provides regulatory guidance to QA and IT staff surrounding configurable systems validation
• Provides clear and concise communication of audit outcomes and management review reporting for regulatory and quality consulting advisements
• Conducts monthly quality management meetings
• Leads and serves as the primary backup, as applicable, for Sponsor Audits, Software Assessments, Critical Vendor Audits, Gap Analyses, Trial Specific Audits, and other critical auditing, risk mitigation, and regulatory assessment activities
• Prepares training materials and conducts training for QA relevant topics
• Assures new hire documentation in the department is completed, including Orientation Checklists and new hire training programs such as 21 CFR 11 and GCP
• Conducts research and prepares statistical reports
• Coordinates and hosts client audits and performs other related duties and tasks as necessary or as assigned

Experience/Qualifications

• Minimum 7 years’ experience in Regulatory/Quality Management position
• Must have previous pharma/biotech experience
• Strong understanding of GCP
• Extensive experience with external and internal auditing
• Lab experience is highly desirable
• Willingness to travel to sites when necessary

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com