Viridian Therapeutics, Inc.
Director, QC Operations
Viridian Therapeutics, Inc., Waltham, Massachusetts, United States, 02254
Viridian Therapeutics, Inc. – Pay Range
This range is provided by Viridian Therapeutics, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base Pay Range $192,000.00/yr - $235,000.00/yr
Direct message the job poster from Viridian Therapeutics, Inc.
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 Executive Director, Quality Control, the Director, QC Operations will lead teams responsible for critical QC functions, including stability program management, supplier oversight, LIMS administration, data trending, and management of key quality systems such as reserve and retention. This role will partner closely with internal stakeholders and external organizations to develop, implement, and continually improve operational strategies while maintaining full compliance with applicable quality and regulatory requirements.
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
Provide strategic leadership to the stability team, including oversight of external partners to support all stages of program development
Collaborate closely with CMC functions, including Analytical Development and Process Development, to ensure aligned QC support
Lead the implementation, configuration, and ongoing management of the LIMS system
Develop, manage, and enhance QC data trending programs to support proactive quality oversight
Oversee external partners (e.g., CMOs, CTLs) to ensure adherence to quality and regulatory expectations
Manage regulatory reserve and retention systems in accordance with global requirements
Support regulatory submissions by authoring and reviewing relevant CMC sections
Prepare QC personnel for inspection readiness, support vendor audits, and serve as the QC subject matter expert during inspections
Oversee quality records within assigned areas, including robust management of OOS/OOT investigations and related deliverables
Qualifications
Requires a BS, MS, or PhD in a life science discipline with a minimum of 12 years of relevant industry experience
Strong background in analytical methods and data analysis, including compendial methods
Demonstrated leadership experience in QC operations and oversight of external CMOs/CTLs
Deep knowledge of cGMP, ICH, FDA, and EU regulations and guidance
Proven hands‑on experience with LIMS administration, configuration, implementation, and validation
Experience with data trending tools (e.g., JMP) and statistical analysis; ability to identify, monitor, and troubleshoot trends
Strong people leadership skills, with experience coaching, developing, and managing staff at various levels
Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 5%
The salary range for this position is 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 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.
#J-18808-Ljbffr
Base Pay Range $192,000.00/yr - $235,000.00/yr
Direct message the job poster from Viridian Therapeutics, Inc.
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 Executive Director, Quality Control, the Director, QC Operations will lead teams responsible for critical QC functions, including stability program management, supplier oversight, LIMS administration, data trending, and management of key quality systems such as reserve and retention. This role will partner closely with internal stakeholders and external organizations to develop, implement, and continually improve operational strategies while maintaining full compliance with applicable quality and regulatory requirements.
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
Provide strategic leadership to the stability team, including oversight of external partners to support all stages of program development
Collaborate closely with CMC functions, including Analytical Development and Process Development, to ensure aligned QC support
Lead the implementation, configuration, and ongoing management of the LIMS system
Develop, manage, and enhance QC data trending programs to support proactive quality oversight
Oversee external partners (e.g., CMOs, CTLs) to ensure adherence to quality and regulatory expectations
Manage regulatory reserve and retention systems in accordance with global requirements
Support regulatory submissions by authoring and reviewing relevant CMC sections
Prepare QC personnel for inspection readiness, support vendor audits, and serve as the QC subject matter expert during inspections
Oversee quality records within assigned areas, including robust management of OOS/OOT investigations and related deliverables
Qualifications
Requires a BS, MS, or PhD in a life science discipline with a minimum of 12 years of relevant industry experience
Strong background in analytical methods and data analysis, including compendial methods
Demonstrated leadership experience in QC operations and oversight of external CMOs/CTLs
Deep knowledge of cGMP, ICH, FDA, and EU regulations and guidance
Proven hands‑on experience with LIMS administration, configuration, implementation, and validation
Experience with data trending tools (e.g., JMP) and statistical analysis; ability to identify, monitor, and troubleshoot trends
Strong people leadership skills, with experience coaching, developing, and managing staff at various levels
Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities
Strong commitment to ethical standards
Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
Ability to travel up to 5%
The salary range for this position is 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 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.
#J-18808-Ljbffr