Are you an expert in GMP Audit and Investigations and have a passion for strategy development and execution?
Do you consider yourself an out of the box thinker looking for your next career opportunity?
Are you willing to relocate to Asia?
Fraser Dove International is partnering exclusively with an innovative, distinguished pharmaceutical organisation seeking an experienced leader to head investigations for all manufacturing plants globally.
Discover more about our Vice president and Head of Investigations opportunity; it’s objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
As the Vice president and Head of Investigations, you will be measured against the following objectives:
1) Perform, audits and document investigations regarding plant issues and critical failures.
2) Continuous surveillance of all sites for consistency in GMP compliance.
3) Facilitating a Culture change by harmonising the Investigations department.
What you will do:
As the Vice president and Head of Investigations, your duties and responsibilities will include:
- Perform, audits and document investigations regarding plant issues and critical failures. This may include investigation of Production, Incoming material quality, Chemistry, Microbiology, Engineering, Validation, and other personnel necessary to complete the investigation.
- Execute and report line defects trend analysis, cost of quality and period quality summaries.
- Evaluate corrective actions in regards to trends. Identify and implement preventive actions to eliminate the potential for non-conformities to occur.
- Participate in audits by regulatory agencies.
- Assist in the investigation of product non-conformances and the gathering of information during regulatory inspections and field actions when required.
- Lead follow-up activities to coordinate the completion of corrective and/or preventive actions.
- Perform effectiveness checks for investigations. Design studies as needed to gather critical data for investigations and/or corrective actions.
- Follow-up on commitments to FDA and other regulatory agency observations for manufacturing related issues and report trends.
- Continuous surveillance of all sites for consistency in GMP compliance.
- Be an active member and facilitate continuous improvement initiatives to assure the continuation of quality measurement, planning, and improvement. Day to day interactions with site Quality personnel in handling change controls, product failures, investigations, data integrity compliance, corrective and preventive actions and effectiveness checks for such implemented actions.
- Responsibility for quality system audits in order to determine compliance to FDA, and internal quality systems regulations.
- Perform quality system surveys to evaluate the overall quality capability of a prospective or actual supplier or contractor.
- Participate in the development, delivery, and administration of quality training programs including but not limited to GMP.
What you will bring:
These are the skills and experience you will need to succeed as the Vice president and Head of Investigations:
- 15+ years’ experience in Quality function and exposure to various Regulatory Inspections including the US FDA, MHRA is a must.
- Handling of investigations and the ability to implement corrective actions
- Functional skills in Production & Quality Assurance of multiple dosage forms.
- Expert in Quality Risk Management activities for all the pharmaceutical dosage forms to safeguard the patient in terms of cross-contamination, mix-ups and containment.
- High on Changeability, Drive, Collaboration, Attention to detail, Resilience and Candor.
What you will get:
These are the perks and benefits that will complement your generous base salary:
- $280,000 – $320,000 + Benefits
Got what it takes?
To apply for the Vice president and Head of Investigations, 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.