Knowledge and Skills:
Strong knowledge of regulatory requirements in GMP/GDP areas
Demonstrated experience with key performance indicators and quality metrics for vendors
Expertise in risk assessment as it pertains to third parties / suppliers
Strong interpersonal skills to explain difficult information and work to build alignment
Demonstrated ability to communicate effectively, both orally and in writing
Mathematical acumen and excellent analytic skills as applied to risk assessments
Demonstrated ability to work well in a matrixed, collaborative environment.
Education and Experience:
Bachelor's degree in a scientific or allied health field (or comparable degree)
Typically requires 6 years of relevant experience, or equivalent combination of education and experience
Must have:
- 6 years’ experience (pharmaceutical)
- Direct experience in Veeva Systems – QMS side of Veeva
- Supervisor experience
- Compliance, been through inspections
- Does not need direct vendor contact – exposure to managing/auditing vendors