Do you have previous experience in hosting and following-up with authority inspections?
Are you looking for an opportunity to write and review QA Standard Operating Procedures (SOPs) related to Drug Safety (DS)/Pharmacovigilance (PV) topics?
Are you located in Germany or the US, or are you willing to relocate?
Fraser Dove International is partnering exclusively with a biopharmaceutical organisation specialising in developing innovative solutions and therapies. Operating worldwide, they are committed to improving and saving lives.
Our client is seeking a proactive individual to take responsibility for the PV auditing strategy, including audits, inspections, and analysis.
Discover more about our Associate Director – Quality Assurance GVP opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Associate Director – Quality Assurance GVP, you will be measured against the following objectives:
1) Ensuring continuous improvement of the internal quality management system.
2) Generating and updating the PV auditing strategy as well as establishing PV quality metrics and analyses.
3) Coordinating and supervising PV audits and follow-ups of authority inspections, especially in PV/safety topics.
What you will do:
As the Associate Director – Quality Assurance GVP, your duties and responsibilities will include:
- Planning, performing, and following up PV and DS audits of internal systems and external vendors.
- Hosting and following-up authority inspections.
- Coordinating and supervising PV audits contracted to external auditors, including the selection of external auditors.
- Writing and reviewing QA SOPs related to DS/PV topics.
- Providing expert advice in GVP for internal procedures within relevant departments.
- Providing GVP support, advice, education, and training to other departments involved in clinical trials and drug safety/PV activities.
- Establishing and maintaining a database of references (regulations, standards, guidelines) applicable to DS/PV topics.
- Ensuring that business goals are met, and the level of Quality remains high.
- 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 Associate Director – Quality Assurance GVP:
- Exceptional communication skills and the ability to collaborate with others.
- Strong problem-solving and negotiation abilities.
- Flexible, highly motivated, with strong organisational skills.
- Persistence and determination to overcome setbacks and drive business performance.
- Sound knowledge in international regulations and guidelines (EU/FDA regulations).
- Experience in hosting and following-up of authority inspections including pre-approval inspections.
- University degree with a minimum of 6 years of professional experience in GVP Quality Assurance within the pharmaceutical and/or biotech industry.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- Flexi working
Got what it takes?
To apply for the Associate Director – Quality Assurance GVP, 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.