Associate Director, GXP Vendor Management & Self-Inspection Program

At Viridian, we are focused on developing best-in-class medicines for people living with autoimmune and rare diseases. Leveraging our team’s expertise in antibody discovery and engineering, we have created a robust pipeline of differentiated investigational therapeutic candidates for well-validated targets.

Reporting to the Sr. Director, Quality Systems, the Associate Director, GXP Vendor Management & Self-Inspection Program will be responsible for ensuring compliance with Health Authorities requirements on Quality and Compliance GXP internal and external auditing programs.

This role is fully remote. Travel to headquarters for meetings may be required at the discretion of management.

Responsibilities (including, but not limited to):

• Lead risk-based analysis on internal and external units to establish frequency and depth of audits
• Schedule and lead as needed, external vendor audits
• Schedule and lead internal audits across the organization
• Interact, as required, with regulatory agencies and customers during inspections and audits
• Provide strategic direction to contract manufacturing & service providers on compliance issues
• Write, review and tracking audit reports, responses and CAPA
• Maintain GXP databases and audit files
• Notify/escalate to Quality Sr. Management potential quality or compliance concerns
• Generate, maintain, and periodically report Quality metrics assessing compliance of internal functions and external service providers
• Maintain and improve Quality Audit program standards and SOPs
• Build, develop, and maintain good working relationships with internal and external customers
• Lead/participate in pre-approval inspection readiness initiatives Accountabilities:
• Represent Viridian with internal and external customers for GXP auditing activities
• Collaborate internal and external auditing activities
• Manage timely execution of audit scheduling, execution, and responses
• Execute robust internal and external audits that ensure customers and functional areas are following applicable regulations.
• Escalate critical issues to Sr Management in a timely manner.
• Support as the SME during inspections and support the inspection management team.
• Manage vendor management activities (e.g., Quality Agreements, Periodic Review, Approved Vendor List Maintenance)
• Provide updates on key quality system metrics
• Support site QA organizations during regulatory inspections

Requirements

• Requires a BS degree in life sciences, engineering, or related field with a minimum 10 years of experience working in a quality role in GxP pharmaceuticals
• Experience performing internal and external audits (auditor qualification preferred)
• Experience in supporting GxP regulatory inspections
• Experience in supporting internal and external audit program activities Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus 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 Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 40%
• The salary range for this position is commensurate with experience

Viridian offers a comprehensive benefits package including:

• Competitive pay and stock options for all employees
• Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents
• Fertility and mental health programs
• Short- and long-term disability coverage
• Life, Travel and AD&D
• 401(k) Company Match with immediate company vest
• Employee Stock Purchase plan
• Generous vacation plan and paid company holiday shutdowns
• Various mental, financial, and proactive physical health programs covered by Viridian

Viridian Therapeutics, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination, harassment, or retaliation of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by Federal, State, and Local laws. Viridian will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Viridian Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.