Senior Manager, Quality Systems and Compliance
Remote
A rapidly expanding Oncology company, with one product already on the market, is looking to add a Senior Manager, Quality Systems and Compliance to their team. The best part, this can be a full-time, permanent, remote position!
The primary responsibilities of this role are to develop, maintain and oversee the Quality Management Systems (QMS) and processes to ensure GxP compliance.
Responsibilities:
- Establish and implement effective QMS measurements, analysis, trending and reporting standards and processes.
- Support the Veeva Vault electronic Document Management System and aid in the administration, implementation, migration activities, and training of existing and upcoming modules in the system.
- Be the primary point of contact for the Veeva QMS module implementation, validation, acceptance testing and launching in the production environment.
- Manage the Quality training program (LMS) including training requirements, curriculum, assessments, and in-person/virtual sessions.
- Assist with the development and implementation of Quality Systems SOPs, Work Instructions, training materials and reference guides.
- Generate compliance metrics to be presented at board meetings with Senior Management.
- Participate in regulatory inspections for their global clinical and commercial programs.
Qualifications:
- Expert level software proficiency with all modules of Veeva Vault, as well as Microsoft Suite and other applications.
- 5+ years in Quality Systems/Quality Assurance/IT experience in the life sciences industry.
- Thorough knowledge of Quality Management Systems, Learning Management Systems and Quality Documentation Systems.
- Excellent communication and collaboration skills.
- Bachelor's degree in Life Science, Computer Science, or related field.
Benefits:
- Non-accrual paid time off
- Summer vacation bonus
- Global, company-wide summer and winter shutdowns
- An annual lifestyle allowance
- Medical, Dental, and Vision Insurance
- 401(k) retirement plan
- Life and Supplemental life insurance for family
- ESPP offering
This remote position is in hot demand, apply today before it's too late!
