Viridian Therapeutics, Inc.
Associate Director, Medical Device Quality
Viridian Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Associate Director, Medical Device Quality
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Associate Director, Medical Device Quality
role at
Viridian Therapeutics, Inc.
About the Role 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 role supports the development and manufacturing of combination products at contract manufacturing organizations (CMOs) and is based in our Waltham, MA headquarters. Office‑based employees are required to work in the office three (3) days a week.
Responsibilities
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), including 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.
Provide design control oversight, including review and approval of device development and risk management documentation for all product lifecycle phases.
Provide leadership and compliance oversight of quality activities associated with medical devices and combination product development and manufacturing processes, internally or at CMOs.
Interact with external vendors regarding device and combination product activities (e.g., design control deliverables, vendor changes, quality agreements) and 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.
Qualifications
Bachelor’s degree with 10+ years of experience in the pharmaceutical/biotech/medical device industries.
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 of 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 with a customer service approach and solution orientation.
Efficient independent worker able to thrive in a fast‑paced environment and drive results.
Strong commitment to ethical standards.
Ability to travel up to 10%.
Salary range commensurate with experience.
Benefits
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 vesting.
Employee Stock Purchase plan.
Generous vacation plan and paid company holiday shutdowns.
Various mental, financial, and proactive physical health programs covered by Viridian.
EEO Statement 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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Base pay range $163,000.00/yr – $200,000.00/yr
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Associate Director, Medical Device Quality
role at
Viridian Therapeutics, Inc.
About the Role 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 role supports the development and manufacturing of combination products at contract manufacturing organizations (CMOs) and is based in our Waltham, MA headquarters. Office‑based employees are required to work in the office three (3) days a week.
Responsibilities
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), including 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.
Provide design control oversight, including review and approval of device development and risk management documentation for all product lifecycle phases.
Provide leadership and compliance oversight of quality activities associated with medical devices and combination product development and manufacturing processes, internally or at CMOs.
Interact with external vendors regarding device and combination product activities (e.g., design control deliverables, vendor changes, quality agreements) and 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.
Qualifications
Bachelor’s degree with 10+ years of experience in the pharmaceutical/biotech/medical device industries.
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 of 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 with a customer service approach and solution orientation.
Efficient independent worker able to thrive in a fast‑paced environment and drive results.
Strong commitment to ethical standards.
Ability to travel up to 10%.
Salary range commensurate with experience.
Benefits
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 vesting.
Employee Stock Purchase plan.
Generous vacation plan and paid company holiday shutdowns.
Various mental, financial, and proactive physical health programs covered by Viridian.
EEO Statement 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.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Base pay range $163,000.00/yr – $200,000.00/yr
#J-18808-Ljbffr