Summary:
A pharmaceutical company that develops and provides innovative biopharmaceuticals for serious diseases and medical conditions is looking to bring on a Manager of Quality Documentation for an initial 12+ month contract. The manager is expected to build effective relationships/partnerships and communicate well with its partners, including Quality Control (internal and external), Quality Assurance, Product Quality Leaders, Technical Development and Regulatory Affairs.
Responsibilities:
- Build an effective partnership and collaborate with Quality Control (internal and external), Quality Assurance and Technical Development to develop and implement an integrated inventory management and documentation system for reagent certification with clear roles and responsibilities.
- Establish and provide routine status reports on the inventory levels to quality management.
- Ensure all individual training and guidelines are kept current.
Qualifications:
- Minimum 6 years of experience in a Quality/Compliance/Regulatory setting
- Sound knowledge of cGMPs and equivalent industry regulations
- Prior experience with technical oversight of Deviations and CAPAs
- Proficiency with computer systems - Microsoft Office Suite
- Proficiency with TrackWise or QMS, LIMS, Oracle, EDMS, and Office365 preferred
Please apply if you are interested!
