Description
Senior Manager - Quality Assurance Auditing - MarylandGlobal Biopharmaceutical Company seeks a Senior Manager working in Quality Systems. This person will be responsible for site audits and inspection readiness/management programs. This is a great opportunity to join a well establish, global company with huge expansion plans.
This person will support all third part audits and inspections performed by US and International regulators specifically in relation to licensed and clinical drug substance.
Responsibilities will include:
- Lead and Manage audits and inspections as the main point of contact.
- Providing info in timely manner
- Supervise and provide guidance to staff in the development of the site's audit and inspection readiness/management program
- Manage general coordination/preparation of audits and inspections inc: logistics/collecting and preparing the pre-reads for the auditors and inspectors/staging documentation (DMF,SMF, SOPs, Validation Docs, Batch records, NCs, etc)
- Scheduling audits/inspections and confirmation of agendas
- Develop and provide training on the audit inspection readiness/management program
- Ensure corrective actions are implemented in response to observations are tracked to closure with target due dates
Requirements:
- Master's or Bachelors Degree with significant experience in Biotech/pharmaceutical industry experience
- 5+ years experience in Quality assurance inc Quality systems
- Management experience is essential
This a fantastic chance to join a very well established company within a supportive collaborative atmosphere. Please upload your resume today or contact Andrew Murphy at Real staffing.