Edgewise Therapeutics has an exciting role in a rapidly growing, innovative clinical-stage pharmaceutical company focused on rare muscle disorders.
About the Position
Edgewise Therapeutics is seeking a highly-motivated and self-directed Quality professional, In this position, you will work as a member of a small highly experienced and innovative team to ensure high quality standards for the safe and reliable production of pharmaceutical products. The ideal candidate will have significant experience in Quality Assurance Document Management and electronic systems. Strong written and verbal communication skills, hands-on execution, and the ability to work with staff across multiple disciplines are essential to be successful in this position.
To learn more about or story and company culture, visit us at https://edgewisetx.com
Essential Duties and Job Functions
- Manage and develop improvements to the Electronic Document Management System (EDMS), including electronic and hardcopy documents
- Thorough knowledge and experience in Veeva Vault QualityDocs and QMS software
- Ensure Document Control (DC) procedures comply with regulatory guidelines including 21 CFR Parts 11, 210, and 211, Eudralex Volume 4, and ICH Q7.
- Provide Doc Control training to staff.
- Be an expert with the EDMS and collaborate consultants and vendors drive improvements and solve problems.
- Lead and guide troubleshooting for complex DC-related issues and systems.
- Maintain all document files, as related to the company, and assists in the archival of documents.
- Lead projects or tasks delegated by Associate Director, Quality Assurance, as requested.
- Takes an ownership role and drives process improvements within EDMS, or other areas of support.
- Trains/mentors less experienced personnel in technical concerns, as well as personal development.
Education & Experience
- Bachelor’s degree in life science discipline and five years related experience
- Prior experience working in a GMP production environment required
- Experience with Microsoft products (Word, Access, Vizio, Excel, and PowerPoint), Adobe Pro, and the internet
- Electronic Document Management System (EDMS) experience, including training others
- Effective communication, both written and verbal skills; ability to effectively present information and respond to questions from co-workers, managers, contractors, and customers
- Project management skills, including prioritization and experience setting standards
- Knowledge of GMP guidelines and ICH regulations pertaining to the production of drug substances and drug products
Working Conditions
Open for remote but occasional in-office work to manage archival of hard copy documents will be required
Salary Range: $70,000 - $115,000. Level and salary will depend on experience level.