- Considered the Subject Matter Expert regarding Data Integrity; support the overall Data Integrity Maturity.
- Participates in internal audits of Data Integrity & Computer System Validation.
- Validation, revalidation, and Periodic Review across Viridian Therapeutics GxP Computerized Systems.
- Work effectively across the organization by engaging with the broader process owner network and site or function process owners in designing and deploying GxP Computerized Systems.
- Work closely with the BPOs to ensure periodic reviews are completed in a timely manner to demonstrate systems have remained in a controlled, validated state and are fit for use.
- Considered the Subject Matter Expert on GxP regulations (21 CFR Part 11, Annex 11 & GAMP5, GDPR, COBIT, ASTM E2500, etc.)
- Oversee / Authors Validation Plans, Configuration Specifications, IQ, OQ/PQ Protocols, Traceability Matrices and Validation Summary Reports, as required.
- Manage authoring, dry running, review, and approval of IQ, OQ and PQ test scripts.
- Manage preparation of all validation deliverables for presentation to QA for approval
- Author and manage resolution and final disposition of all validation incidents identified during test execution.
- Provide guidance to Viridian Therapeutics regarding validation requirements and support the CSV Maturity.
- Maintain Computer System Validation master list and manages / conducts periodic reviews of Viridian Therapeutics CSV program.
- Support Vendor Audits and Supplier approval process where applicable with respect to Data Integrity and Computer System Validation.
- Provides Subject Matter Expert support for Risk Assessment and Mitigation strategies for CSV related incidents or deviations.
- Requires a bachelor's degree with 10+ years industrial experience, or an equivalent combination of training and experience.
- Demonstrated knowledge of relevant Quality compliance processes and regulations, e.g. Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
- Demonstrated influential leadership expertise and experience with senior level interactions and influence with Manufacturing, Engineering, IT and Quality
- Proven knowledge and experience implementing IT Governance following COBIT Framework
- Familiar with electronic quality system tools (e.g. Veeva Vault)
- Proficient in Computer System Life Cycle change requirements and implementation with an emphasis on SDLC, GAMP 5, and ASTM E2500
- 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
- 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
Associate Director, Data Integrity - Waltham, United States - Viridian Therapeutics Inc.
Description
At Viridian Therapeutics (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, strategic 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, Data Integrity & Computer System Validation is responsible for monitoring process metrics to achieve Quality outcomes that ultimately drive continuous improvement working across the matrix organization with Business Process Owners (BPO), other Key Stake Holders, and Subject Matter Experts (SME).
The incumbent will be an integral part of Viridian Therapeutics' Quality Team who performs activities related to the Quality Oversight of Data Integrity with clinical trial data collection, data and document transfers from CRO's and CMO's to Viridian and Viridian partners.
In addition, computer system validation of internal Viridian systems as well as oversight of vendors computer system validation and change control.
Responsibilities (including, but not limited to):
The candidate should reside in the Greater Boston area and be comfortable coming into the office on a regular basis.
Viridian Therapeutics offers a comprehensive benefits package including:
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.