Senior Director International GDP Operations

A global biotechnology company who are a market leader in their therapeutic area are looking for a Senior Director Quality to join their team.

A highly strategic role, you will be a Qualified Person and have a proven background implementing strategic quality and compliance programs/measures on a global basis. International experience is essential for this role.  Demonstrable leadership capability is vital for this role, you will be confident in managing and developing key business relationships internally and externally.

As our client is developing their portfolio within cell and gene therapy, experience within this area is highly advantageous.  

Working on special projects and implementations, this is a great opportunity to further your career in a forward thinking business. 

An innovative biotech business who seek to grow and develop their international pipeline you will have experience in developing new countries and regions from a quality perspective as well as adding value to the wider business.

This is a great opportunity to work for a pharmaceutical company who have created a centre of excellence and constantly focus on driving innovation and using cutting edge techniques in their science.

Key Responsibilities

• Establish international strategic quality and compliance processes across several therapeutic areas whilst monitoring industry trends and best practices
• Provide strategic direction and management to the development and improvement of quality and compliance strategies and ensure these meet global regulatory requirements
• Create global Quality Risk Management Systems as well as identifying and evaluating cross functional risks
• Generate strong partnerships with stakeholders and leadership teams
• Develop strategic connections with global regulatory agencies

Requirements

• B.S. or M.S. PhD in a scientific field
• Qualified Person
• Extensive experience in Quality Assurance and risk-based quality principles in a pharmaceutical setting
• Excellent knowledge of global regulatory agencies as well as industry trends and best practices
• Great understanding of GCP and GLP guidelines
• Experience with quality assurance within a distribution setting
• Proven experience in implementing quality strategic planning
• Excellent leadership, communication, and project management skills

Park Street People Ltd does not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and complies with all relevant UK legislation. We are acting as an Employment Agency in relation to this role.