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 Executive Director, R&D Quality the Sr. Manager/AD, R&D Quality is responsible for Provide Quality Assurance oversight by executing audits, ensuring compliance with GxP regulations, managing risk, supporting inspections, driving issue resolution, monitoring compliance metrics, updating procedures, conducting regulatory intelligence, and providing training.  

It is preferable this role is based near the in Waltham, MA office which would be a hybrid role. Our office-based employees are required to work in the office three (3) days a week.

Responsibilities (including, but not limited to):

• Provide Quality Assurance strategy and oversight to ensure compliance with GCP, GLP, cGLP, and/or GVP   regulations across studies, projects and programs
• Support development and execution of GxP vendor audits according to the vendor audit plan
• Support development and execution of clinical investigator site audits according to annual audit plans
• Support development and execution of internal audits according to internal audit plans
• Actively identify and contribute to the GxP Risk Management processes
• Partner with the cross functional GxP teams to develop and improve Viridian processes and procedures such as Policies, SOPs, Work Instructions and Forms, and trial documentation such as protocols, reports, transfer plans, system and study manuals, etc.
• Lead inspection readiness and support sponsor, vendor and site GCP/GLP/GVP regulatory inspections globally.
• Drive GxP quality issue compliance through the identification and documentation of deviations, CAPAs, effectiveness checks, and change controls.
• Monitor, analyze, and report compliance metrics to management as appropriate, and guide teams on improvements.
• Assist with or provide GCP/GLP/GVP training to employees as appropriate

Requirements

Qualifications:

• Requires a Bachelor’s degree in Life Sciences of related discipline is required (Advanced degree a plus) with 8+ years of biotech/pharmaceutical experience
• Clear record of success in R&D QA in the biotech/pharmaceutical industry
• Thorough understanding of FDA, ICH and EMEA guidelines and regulations
• Excellent time management skills and the ability to work with a sense of urgency
• Demonstrated leadership and collaboration skills in a cross-functional project team
• Strong oral and written communication including the ability to present information clearly and logically
• Ability to anticipate and address issues, prioritize, and manage multiple projects to meet critical deadlines
• Strong attention to detail and problem-solving skills
• Works effectively in a team environment
• Strong commitment to ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• 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.