QA Senior Manager / Manager
A specialty clinical development company is seeking a growth-minded QA Manager to join their rapidly expanding team! This position is brand-new requisition, and will be one of the key additions to the rapidly expanding Quality team. If you enjoy wearing multiple hats, this role is for you!
The QA Manager / Senior Manager will have the following responsibilities:
- Responsibility for day-to-day Quality Assurance oversight and management of quality operations for the company
- Establish PAI plan to includes identification of documentation needed to support the approval efforts, establish timelines for completion and delegate where required.
- Develop and re-vamp SOPs
- As needed/required, lead or support Client/Partner audits or Regulatory Inspections.
The ideal candidate will have the following skill set:
- Bachelor's Degree or equivalent skills or work experience.
- A minimum of 5 years' preferred experience in the pharmaceutical industry with related experience in Quality Assurance, Quality Control and Manufacturing.
- A minimum of 2 years supervisory, management or leadership role in the pharmaceutical industry.
- Phase I GMP expertise