Do you have at least 5 years of previous experience in GCP auditing and PV auditing?
Are you looking for an opportunity to prepare, host and follow up with GCP regulatory authority inspections?
Are you located in Munich, Germany, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a pharmaceutical organisation, specialising in creating and supply innovative pharmaceutical products. Operating worldwide, our client is committed to saving lives.
Our client is seeking an experienced GCP leader to prepare, host and follow up regulatory authority inspections.
Discover more about our Senior Manager GCP Audit opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Senior Manager GCP Audit, you will be measured against the following objectives:
1) Supporting all aspects of GCP regulatory inspections at investigator sites and CROs.
2) Providing assurance to the Global QA GxP Audits Team.
3) Preparing and conducting responses to inspections and overseeing supporting documentation, tracking and verification of CAPA implementation.
What you will do:
As the Senior Manager GCP Audit, your duties and responsibilities will include:
- Managing the investigator site, service provider and process audit program to assure an acceptable state of compliance.
- Ensuring that all studies are performed in compliance with GCP requirements and can withstand scrutiny from regulators.
- Managing metrics and tracking corrective and preventative actions as follow up to audits and inspections.
- Developing and implementing QA GCP objectives and audit schedules.
- Collaborating and representing the Global QA group in conducting joint audits and global SOP development.
- Liaising with internal teams to ensure local and global compliance with regulatory requirements and internal standards.
- Proactively integrating quality and process improvements.
- Serving as the GCP expert during all regulatory agency clinical inspections.
- Developing and measuring GCP KPIs to drive continuous improvement.
What you will bring:
These are the skills and experience you will need to succeed as the Senior Manager GCP Audit:
- Ability to nurture partnerships with internal and external stakeholders.
- Demonstrable leadership skills and ability to communicate with people of all levels.
- Ability to work interculturally and travel 30% across Europe and globally.
- Profound knowledge of international GCP regulations and guidelines.
- Experience in preparing, hosting and following-up of regulatory authority inspections.
- A minimum of 5 years of previous experience in GCP auditing; additional PV auditing experience preferred.
- Bachelor’s degree in a life science-related discipline.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Subsidised travel
Got what it takes?
To apply for the Senior Manager GCP Audit, click the ‘Apply’ button below or contact the Executive Search Consultant – 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.