Are you a proactive leader with previous experience in a GCP Quality/compliance position?
Are you looking for an opportunity to provide strategic GCP, GLP, and GPVP compliance oversight for clinical studies?
Are you located in San Diego, US, or are you willing to relocate?
Fraser Dove International is working exclusively with an innovative pharmaceutical organisation specialising in the development of a cure for cancer. With several drug candidates under their belt, they are committed to building a leading oncology franchise.
Our client is seeking an experienced, highly motivated executive to manage compliance-related to Good Clinical Practices (GCP’s), Good Laboratory Practices (GLP’s), Good Pharmacovigilance (GPVP’s) and other activities.
Discover more about our Senior Director (Clinical Quality) opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Senior Director (Clinical Quality) you will be measured against the following objectives:
1) Providing strategic GCP, GLP and GPVP compliance oversight for clinical studies and internal operations.
2) Promoting collaboration to ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations, and guidelines.
3) Working with Clinical Operations and Regulatory Affairs to review IND and NDA submissions to ensure data and documents meet GCP guidelines.
What you will do:
As the Senior Director (Clinical Quality), your duties and responsibilities will include:
- Leading the Clinical Quality Assurance (CQA) function while promoting a culture of quality by collaborating across all departments and levels of management.
- Meeting the ongoing needs of the quality assurance department by maintaining CQA compliance for the ongoing and planned clinical trials.
- Partnering externally to perform effective audits of vendors, investigator/clinical sites and ensure documents are tracked and maintained within standards.
- Creating Good Clinical Practice (GCP) training and development plans for Quality staff to drive competence and professionalism.
- Planning coordination, control and continuous improvement of processes and systems to ensure the quality of clinical studies.
- Creating, maintaining, and revising Standard Operating Procedures (SOPs) that support the Quality Management System.
- Actively leveraging audit outcomes/trends to achieve sustained improvement in clinical trial conduct and reporting.
- Assessing new and emerging regulations and ensuring they align with the Quality Management System and practices.
- Identifying issues with processes and completing or coordinating corrective action.
What you will bring:
These are the skills and experience you will need to succeed as the Senior Director (Clinical Quality):
- Exceptional communication skills and ability to collaborate with others.
- Ability to work with limited direction to follow through with specific tasks.
- Demonstratable leadership skills and ability to communicate with people of all levels.
- Ability to multi-task and shift priorities quickly while working under time constraints.
- Deep understanding of clinical processes and procedures, electronic documentation systems, and GCP, GLP and GPVP regulations.
- Minimum of 15 years’ previous experience in the pharmaceutical industry with a GCP focus.
- Bachelor’s degree or equivalent in life science-related field.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- 401k plan
Got what it takes?
To apply for the Senior Director (Clinical Quality), click the ‘Apply’ button below or contact the Executive Research Manager – Kaitlin Francis – 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.