Vice President of Quality

Vice President (Head) of Quality - East Coast (United States)

RRxCo is partnered with a clinical-stage Biotechnology Company that develops novel medicines for severe immune disorders. This exciting and innovative firm is expanding its team by creating an opening for a VP, Head of Quality. Focused on the field of auto-immune disorders, our client is set to develop several assets over the coming years.

Summary

The business is on the cusp of initiating Clinical studies and needs a dedicated professional to establish and maintain the Company’s Quality System to GxP compliance.

The ideal individual will have extensive experience in developing and implementing quality systems within the biotechnology or pharmaceutical industry and a deep understanding of regulatory requirements (GxP) and industry standards.

Deliverables

-Develop, maintain, and constantly look to improve the Quality Management System (QMS) in compliance with Regulatory requirements:

• Establish and enforce quality policies, procedures, and standards to ensure compliance and operational excellence.
• Continuously evaluate and improve quality systems to support company strategy, including CMC and clinical activities.
• Develop and maintain risk-based methodologies.
• Oversee administration, tracking and maintenance of the training program in accordance with the GxP requirements.
• Ensure all company operations follow relevant regulatory requirements and industry standards.
• Stay current with regulatory changes and updates, providing guidance on their impact on the organization.
• Support the management of the electronic document management system and all other systems used as part of the Quality System
• Oversee the preparation and review of quality-related documents, including SOPs, protocols, reports, and validation documents.

-Audit Readiness:

• Establish an Audit readiness program.
• Prepare for and manage regulatory inspections and audits, addressing any findings and implementing corrective actions.
• Is the main Quality contact for external audits and inspections.

-Team Leadership and Training:

• Build and lead a high-performing quality team, providing mentorship and guidance
• Conduct regular training sessions for staff to ensure awareness and understanding of quality systems, policies, and procedures.
• Foster a culture of quality and continuous improvement throughout the organization.
• Collaborate with cross-functional teams, to ensure alignment on quality objectives and initiatives.
• Serve as the primary point of contact for quality-related matters internally and externally.

Profile of the Individual

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field; ideally in Quality or Pharmacy.
• Extensive experience in quality management within the biotechnology or pharmaceutical industry.
• Proven track record of successfully developing and implementing quality systems.
• In-depth knowledge of regulatory requirements and implementations (FDA, EMA, MHRA etc).
• Strong leadership and team management skills, with the ability to mentor and develop quality staff.
• Excellent problem-solving and decision-making abilities.
• Ability to work with international teams.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams.
• Experienced understanding of drug candidate development.