£84.4k per year
over 1 year ago
A West-Coast based late-stage pharmaceutical company that is developing drug treatments for central nervous system (CNS) disorders is looking for an experienced Quality individual with a clinical operations profile to join their exciting team in order to bridge the Quality and Clinical Operations functions in a Director level role.
If you're based in Pennsylvania, New Jersey, New York, or Massachusetts, (as they are looking to open an East-Coast office in one of these locations) and are looking for that next step in your career in a role that will give you autonomy to mould it into how you best see fit, then apply now!
Essential Duties and Responsibilities Include the Following.
- Meet the ongoing needs of the quality assurance department by maintaining CQA compliance for ongoing and planned clinical trials.
- Work with clinical operations and regulatory affairs to review IND and NDA submission documents.
- Lead investigations and write CAPAs on GCP issues as they arise.
- Responsible for ensuring submission data and documentation meets GCP guidelines.
- Perform and/or support audits of clinical sites, CROs and other clinical vendors.
- Ensure proper maintenance of the Quality systems.
- Directly interface with Clinical Operations to provide support for vendor, site, and internal GCP audits.
- Assist with writing and editing documents needed for the clinical quality management system.
- Update and maintain CQA SOPs that support the quality systems.
- Manage and update electronic libraries.
- Assist in authoring clinical operation SOPs and processes as needed.
- Facilitate meetings with CRO's and other clinical entities as appropriate.
- Ensure Trial Master Files are maintained within standards.
- Other duties as assumed or assigned.
- Develop and support established records management procedures.
- Provide input and change management for quality improvements affecting CQA systems.
Education, Experience and/or Skills Required
- 10 cumulative years of related quality or clinical experience within pharmaceutical companies or Contract Research Organizations (CROs).
- Education and experience in an FDA-regulated environment.
- Bachelor's degree
- Ability to plan and organize work in an efficient manner and work well under time constraints.
- Demonstrates effectiveness in maintaining CQA control systems for compliance with FDA regulations.
- Must have experience using MS Office
- Broad knowledge of clinical processes and procedures, electronic documentation systems, and Good Clinical Practices 21CFR Parts 50, 56, and 312.
- Demonstrates initiative and proactively provides collaborative support to the clinical teams.
- Experience in MasterControl or a similar ECM system is a plus.
- Willing to travel 20-30%.