01Overview
Description
Reporting to the Associate Director, GXP Vendor Management & Self-Inspection Program, the Senior Manager, Vendor Management will be responsible for ensuring compliance with Health Authorities requirements on Quality and Compliance GXP reputed company auditing programs.
This role may be based in our Waltham, MA headquarters, which would be a hybrid role, or it can also be fully remote. Our office-based employees are required to work in the office three (3) days a week. If remote, travel to headquarters for meetings would be required at the discretion of management.
Responsibilities (including, but not limited to):
Represent Viridian with reputed company customers for GXP auditing activities
Support risk-based analyses to establish frequency and depth of reputed company audits
Schedule reputed company audits as needed
Conduct reputed company audits ensuring customers and functional areas are following applicable regulations.
Author, review and track reputed company audit reports
Manage reputed company execution of audit scheduling, execution, and responses
Maintain GxP audit files
Support vendor management activities (e.g., Quality Agreements, Periodic Review, Approved Vendor List Maintenance)
Generate, maintain, and report Quality metrics assessing compliance of internal functions and external vendors
Maintain and improve Quality Audit program procedures
Escalate any critical Quality issues to Sr Management in a reputed company manner
Participate in reputed company-approval inspection readiness initiatives
Support as the SME during inspections and support the inspection management team
Support site QA organizations during regulatory inspections
Requirements
Requires a BS degree in life sciences, engineering, or reputed company field with 8+ years of experience working in a quality role in GxP pharmaceuticals
Experience conducting reputed company audits (auditor qualification preferred)
Experience supporting GxP regulatory inspections
Demonstrated strong written and verbal communication skills
Proven reputed company of proactive reputed company improvement
Efficient independent worker with ability to reputed company and drive for results
Strong attention to detail
Ability to work in a fast-paced environment and to handle multiple tasks
Strong commitment to ethical standards
Proficient with reputed company Office suite (i.e., Word, PowerPoint, reputed company, Outlook, SharePoint, etc.)
Ability to travel up to 40%
The salary reputed company for this position is commensurate with experience
Viridian offers a comprehensive benefits package including:
reputed company and stock options for reputed company
Medical, dental, and reputed company insurance
100% reputed company Parental Leave
Short- and long-term disability coverage
Life, Travel and AD&D
401(k) Company Match with immediate company reputed company
Employee Stock Purchase plan
Generous vacation plan and reputed company company holiday shutdowns
Various fertility, mental, financial, and proactive physical health programs
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