Associate Director, Quality Systems - Waltham, United States - Viridian Therapeutics

Description

At Viridian, 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.

We are currently seeking an Associate Director/Director of Quality Systems who will thrive in a collaborative and fast-paced environment. The Associate Director/Director of Quality Systems will assess and enhance Viridian's quality systems, ensuring compliance and inspection preparedness. The incumbent will oversee and perform Quality system tasks for Deviations,
CAPAs and, Change Control Programs. The incumbent will also coordinate and prepare for quarterly quality management reviews with the executive and senior leadership teams.

This role will be responsible for the Quality Risk Management function including risk reporting/intake, risk review, risk escalation, risk quality council and documentation.

This role will support validation of computer systems by defining system requirements and assisting in completion of validation scripts. This role will be a key member of the inspection logistics team as well as an SME during inspections. The incumbent will back up the Training and the Document Control function as needed.


Responsibilities:
Responsible for the oversight, implementation, and maintenance of Viridian's Quality Management System (QMS), including but not limited to...

Deviations

CAPA
Change Control
Quality Risk Management
Quality Management Review Coordination
Involvement in ongoing computer system validation
Back up to document control and training
Metrics for monitoring health of quality systems

Implement and maintain programs to ensure the validation, monitoring, and effectiveness of Viridian's QMS and its compliance to pertinent regulations and standards
Collaborate with other departments, ensuring the right modules are implemented and effectively support Viridian's programs
Lead, coordinate, and execute activities in preparation of FDA and other regulatory inspections and other audits, as they relate to the QMS
Implement and oversee the Quality training program and ensure proper maintenance of training records
Approve SOPs, Work Instructions and Forms on behalf of the QA department
Collaborate with vendors and internal departments to identify and resolve QMS issues

Requirements

Bachelor's degree in Life Sciences or related discipline and a minimum of 7 years of work experience in biotech/pharmaceutical industry preferred.

Knowledge of and experience with Electronic Quality Management Systems required
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 is a remote position.

Compensation:
The salary range for this position is commensurate with experience.

Viridian offers a comprehensive benefits package including:
Medical, dental, and vision coverage with 100% of premiums paid by Viridian for employees and their eligible dependents.
Short- and long-term disability coverage
Group term life insurance
Medical and Dependent Care FSA
401(k) Company match
Employee Stock Purchase Plan

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.

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