Are you an ambitious individual with previous experience as a Quality Assurance (QA) Manager?
Are you looking for an opportunity to verify that the QA system is effective and adheres to industry best practices?
Are you located in San Francisco, USA, or are you willing to relocate?
Fraser Dove International is partnering exclusively with an innovative organisation specialising in developing drugs to treat rare diseases. Operating worldwide, they are committed to making a difference in patients’ lives.
Our client is seeking a driven individual to oversee the QA function and design systems and procedures to ensure that business goals are met.
Discover more about our Clinical Quality Assurance Manager opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Clinical Quality Assurance Manager, you will be measured against the following objectives:
1) Working closely with the on-site and global team in alignment with Good Clinical Practice (GCP).
2) Designing and modifying policies, systems and procedures to improve QA.
3) Executing external and internal audits in a timely manner.
What you will do:
As the Clinical Quality Assurance Manager, your duties and responsibilities will include:
- Working closely with Clinical Quality and Corporate Quality team to deliver clinical quality services.
- Designing and modifying policies, systems and procedures associated with clinical quality.
- Conducting internal and external Good Manufacturing Practice (GMP) audits of systems and processes.
- Providing expertise and guidance to various departments to assure clinical trials are conducted in accordance with GCP.
- Working with internal stakeholders to develop new Standard Operating Procedures (SOPs).
- Ensuring that business goals are met, and the level of Quality remains high.
- Demonstrating the highest level of detail within clinical quality compliance.
- Working with Contract Research Organisation (CRO) staff in the proper execution of GCP.
- Ensuring the QA system is effective and adheres to industry best practices.
What you will bring:
These are the skills and experience you will need to succeed as the Clinical Quality Assurance Manager:
- Ambitious individual with the ability to hit the ground running in new environments.
- Strong stakeholder engagement with ability to work cross collaboratively.
- Ability to manage projects and prioritise appropriately.
- Knowledge in designing Protocols, Clinical Monitoring, QA Planning, Deviations, Corrective and Preventative Action (CAPA) and Audit Findings.
- Experience working with CROs to execute internal and external audits and inspections.
- Minimum of 5 years’ experience in Biopharma industry and Clinical QA or Clinical Operations.
- Bachelor’s degree in science related discipline.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Generous holiday allowance.
Got what it takes?
To apply for the Clinical Quality Assurance Manager, click the ‘Apply’ button below or contact the Global 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.