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 Sr. Mgr./Associate Director of Document control is responsible for the development of systematic control and management processes for GxP documents throughout their lifecycle and for establishing procedures to ensure records (paper and electronic) are maintained in compliance with global regulatory and legal requirements, as well as site requirements and procedures.

Responsibilities:

· Responsible and accountable for the development, deployment and implementation of effective and efficient standards, procedures, and best practices for global and site documentation management and control including periodic review, change process, retention and archival.

· Assists in developing the overall global Quality Standards strategy and implementing the quality documentation hierarchy for global and site documentation, including development of process for gap assessments and implementation planning.

· Partner with IT to implement, administer, maintain, and continuously improve the electronic documentation management system, Veeva QualityDocs.

· Partners, educates, and collaborates with Documentation Control, QA, and SOP authors/owners in other functional areas for the development, deployment and maintenance of the document management program and records retention schedule.

· Provides support during internal and external audits, including Regulatory Health Authority inspections.

· As needed, works with Quality Assurance and functional area representatives or responsible change owners to develop change management strategies.

· Accountable for development and management of effective documentation system KPIs, metrics, management review, and proactive issue identification and resolution.

· Ensures the documentation system is scalable and flexible to support initiatives and communicates effectively with all cross functional and regional stakeholders on matters related to the documentation system and e-DMS.

Requirements

· BA/BS in the Life Sciences is required. MS degree in Life Sciences a plus.

· Minimum 7-10 years' experience in Document Management and Control and 3-5 years' experience in Change Management in FDA-regulated, GxP-related Industry is required.

· Working knowledge of electronic change management systems or e-DMS required.

· Experience with 21 CFR, ICH, GDPR, ISO 13485 and EMEA guidelines and regulations.

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

· Demonstrated ability to interact and communicate effectively with peers, senior management, regulatory officials, and auditors. Proven interpersonal skills with face to face and remote teams.

· 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.