Associate Director of GCP Quality
Are you a clinical quality professional looking to lead and build a GCP function within a valuable, young organization?
Do you hold experience carrying out GCP Quality Audits?
Do you have the energy and passion to set a plan and really drive it to help create a critical function within an organization?
Fraser Dove International is working with one of the world’s most valuable biotechnology organizations. They currently have over ten clinical programs and this will double by the end of the year. They are innovative and research-driven, over half of the clinical programs are their own developments. This organization is investing just as much into digital AI as they are in research.
Discover more about our Associate Director of GCP Quality opportunity and the skills, experience and competencies needed to succeed.
The Associate Director GCP Quality is a vital team member that will be bold with their approach to lead GCP Quality audits and assist the Senior Director GCP Quality with building out the GCP function within a fast moving, young organization.
They are looking for an experienced GCP Quality professional to join the team. This opportunity provides a great platform for an individual to make a difference and play an essential part in bringing some of the most exciting, innovative new therapies to market.
It is an opportunity for the Associate Director GCP Quality to implement their ideas and strategies to lift and build a successful GCP function.
What you will do:
If you impress during the hiring process and are offered the job, these will be your objectives:
Build the GCP function
- This position will see you implementing strategies, building key stakeholders and process framework to build the GCP function
- Be a strong collaborator across multiple functions and have a hands-on approach to leading GCP Quality Audits
Subject Matter Expert for GCP
- Provide guidance, ensure compliance and facilitate and develop training for personnel
Your duties and responsibilities will include:
- Develop and implement standards, policies and procedures for GCP compliance
- Review and produce protocols, method validations and study reports
- Present quality data and metrics and advise senior management of issues and provide corrective actions
- Organize and lead all GCP audit activities
- Provide information on GCP regulations, standards and quality systems
What you will bring:
The skills and experience you will need:
- 8+ years’ experience in Biotechnology or pharmaceutical
- Extensive experience in auditing
- 8 + years’ experience in quality systems related to GCP
- Strong analytic skills
- Working knowledge of FDA and global regulatory compliance
What you will get:
The perks and benefits you will receive:
- Full extensive benefits package
Got what it takes?
To apply for the Associate Director of GCP Quality role, click the ‘Apply’ button below or contact the Executive Search Consultant – on +44 (0)203 355 7050.
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
- If you have not heard from an Executive Search Consultant within five working days from the date of your application, please consider yourself unsuccessful. Check back regularly for the latest senior-management and executive opportunities from leading life science organisations and emerging startups across America and the EMEA.
Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.