Associate Director, Clinical Quality

Description

At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driven decisions, thoughtful risk-taking, and efficient use of time and funds to best position our ideas for success. We value thoughtful ideas, open communication, and transparency, and are committed to a culture that allows employees to contribute at a high level, grow their careers, and balance their personal and professional ambitions.

The Associate Director of Clinical Quality is responsible for the maintenance of quality processes and procedures that ensure compliance with Good Clinical Practices (GCP) guidance and relevant country regulations. Provides guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance. Works directly with Viridian Clinical Operations, Development and Pharmacovigilance departments to provide continual support to enforce requirements and meet guidelines. Interacts with clinical vendors to ensure vendor compliance with GCPs and relevant country regulations. Ensures the clinical quality processes and procedures are maintained regularly.

Responsibilities:

* Provide Quality Assurance strategy and oversight to ensure compliance with Good Clinical Practices (GCPs

* Support strategic vendor and site audit plans.

* Drive audit preparation activities for regulatory GCP inspections and guide coordination of audit responses

* Support external GCP audits at Investigator Sites, CROs, supporting laboratories, and monitoring organizations including writing audit reports and tracking resulting CAPAs.

* Distribute detailed audit reports that clearly identify audit findings and audit commitments.

* Ensure timely completion of all audit commitments, post-audit activities, and corrective & preventative actions.

* Ensure adequate vendor oversight and address any quality issues as needed.

* Review critical processes and procedures to identify gaps in standards, procedures and technologies that are a risk to clinical trial quality.

* Collaborate with cross-functional teams to develop and implement clinical quality plans to reduce/mitigate risk to clinical trial quality.

* Participate in initiatives related to critical quality processes such as essential document management, data management, trial management, investigational product management, etc.

* Partner with the Clinical team to write, revise, and approve appropriate SOPs, Work Instructions and Forms

Requirements

* Bachelor's degree in Life Sciences or related discipline

* A minimum 6+ years of work experience in biotech/pharmaceutical industry preferred.

* Experience with FDA, ICH and EMEA guidelines and regulations

* Excellent time management skills and the ability to work with a sense of urgency.

* Strong oral and written communication including the ability to present information clearly and logically.

* Ability to prioritize and manage multiple projects to meet critical deadlines.

* Strong attention to detail and problem-solving skills

* Works effectively in a team environment

This position is required to reside in the Northeast. It is a hybrid work model based out of our Waltham, MA HQ.

Viridian offers a comprehensive benefits package including:

* Remote work with technology tools and infrastructure

* 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.

* Company paid insurance 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 Therapeutics, Inc participates in E-Verify, the federal program for electronic verification of employment eligibility.