The Senior QA Manager will assure all systems, processes, and their outcomes comply with standards that meet applicable international and national regulations, guidelines and fulfill client and Covance requirements.
Essential job duties listed below (* indicates potential direct client interaction)
- Provides leadership for a QA team by ensuring individuals have the appropriate education, training and experience to fulfill their role.
- Designs and delivers appropriate training material and trains and mentors team as required.
- Ensures resources are available to appropriately execute QA processes, mitigate compliance risks and provide quality oversight of the sites operations.
- Performs/supports internal/vendor audits.
- Hosts client and regulatory inspections.*
- Acts as QA Management representative during strategic client interactions.*
- Accountable for budgetary planning and cost control for their assigned areas of responsibility.
- Identifies and leads departmental and/or company projects/initiatives. Leads process improvement and harmonization efforts that promote best practices.
- Provides management support and guidance during issue management resolution .*
- Provides regulatory/industry/company consultation and guidance as needed.
- Develops/revises SOPs/other controlled documents.
Other essential job duties as assigned by management.
- Bachelor’s Degree or equivalent experience – Science related field preferred.
- Minimum of 8 Years of experience in the job discipline or other related roles. Prefer working experience in CAP, ISO 15189 and undertand GCP and clinical trial
- Demonstrated understanding of Quality Assurance in a regulated laboratory environment
- People management experience
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