Description

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, Medical Device Quality, the Associate Director is responsible for providing leadership and compliance oversight of quality activities associated with medical devices and combination product development that meet applicable regulatory requirements and industry standards. The Associate Director will play a critical role in development and manufacturing of combination products at contract manufacturing organizations (CMOs).

This role is based in our Waltham, MA headquarters. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Represent medical device Quality as subject matter expert and core team member on device development projects
• Support design and development phases, clinical readiness, commercial approval / launch, and regulatory submissions of Viridian combination product program(s). Support the completion of milestones associated with specific projects throughout the program lifetime
• Ensure proper implementation of Design Controls through project phases including Planning, Design Inputs & Outputs, Design Verification and Validation (V&V) and Design Transfer
• Design control oversight, including review and approval of device development and risk management documentation for all phases of the product lifecycle
• Responsible for providing leadership and compliance oversight of quality activities associated with medical devices and combination product development and manufacturing processes internally or at contract manufacturing organizations (CMOs)
• Interact with external vendors in relation to device and combination product activities e.g., design control deliverables, vendor changes and quality agreements. Conduct vendor audits as needed
• Support Quality Assurance responsibilities related to product development, test method validation, human factors engineering, process validation, shipping validation, clinical & commercial readiness, and CMO oversight
• Support cross functional activity to ensure audit readiness is in place for all aspects of the product lifecycle

Requirements

Qualifications:

• Requires a bachelor’s degree with 10+ years’ experience in the pharmaceutical/biotech/medical device industries
• Requires design control/design assurance experience supporting device development from a Quality standpoint
• cGMP experience in Quality from clinical phases through commercial release is preferred
• Understanding global requirements for GxP quality systems and vendor quality management for commercial and clinical products
• Experience conducting vendor audits
• Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change cross-functionally
• Proven mindset of proactive continuous improvement
• Strong team player that has a customer service approach and is solution oriented
• Efficient independent worker with ability to work in a fast-paced environment and drive results
• Strong commitment to ethical standards
• Ability to travel up to 10%
• 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
• Competitive medical, dental, and vision coverage
• 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.