Website:
eclipticinsight.com
Job details:
DeepHow | Full-Time | Fully Remote
Job Summary
DeepHow is seeking an experienced Quality Consultant / Lead to independently manage quality assurance, regulatory, and GxP compliance projects for DeepHow and its clients. The consultant will serve as a subject matter expert (SME) in Quality Assurance and GxP compliance while helping establish, maintain, and continuously improve DeepHow’s Quality Management System (QMS). The role will support SDLC, CSV, AI, Data Integrity, and GxP compliance, including the design, implementation, monitoring, maintenance, and continuous improvement of quality programs, policies, and strategies.
Key Responsibilities
● Serve as a subject matter expert in Quality Assurance, regulatory, and GxP compliance.
● Establish, implement, and maintain the company’s QMS program.
● Manage QMS activities including vendor qualification, CAPA management, internal audits, management reviews,
change management, and procedure/SOP review and updates.
● Provide independent consultation and manage quality and compliance projects.
● Support CSV and Data Integrity compliance strategies.
● Support SDLC and risk-based, phase-appropriate GxP projects.
● Monitor regulatory and technological developments affecting GxP compliance.
● Provide GxP consultation to clients and internal functional teams.
● Support investigations involving deviations and non-conformances.
● Provide guidance on appropriate CAPA development and implementation.
● Develop, review, and maintain SOPs and quality procedures.
● Deliver quality and compliance training to clients and internal teams.
● Educate employees at all levels on quality and compliance requirements.
● Promote a culture of continuous improvement and quality across the organization.
● Support other quality, regulatory, and compliance initiatives as assigned.
Required Qualifications
• 10+ years of relevant experience in Quality Assurance, Regulatory, and/or GxP compliance.
• Strong knowledge of applicable US FDA, ICH, EMA, and MHRA regulations and guidance.
• Excellent knowledge of 21 CFR Part 11 and EU Annex 11.
• Proven experience developing and maintaining a Quality Management System (QMS).
• Strong expertise with GxP-regulated systems and the ability to provide independent consultation.
• Experience with CAPA, deviations, non-conformances, change management, audits, and vendor qualification.
• Experience supporting CSV and Data Integrity initiatives.
• Strong project management and client-facing consulting skills.
• Excellent written and verbal English communication skills.
• Ability to manage multiple quality and compliance projects simultaneously.
• Strong interpersonal skills and the ability to work effectively with clients and cross-functional teams.
• Bachelor’s degree or equivalent college degree, preferably in a scientific or life sciences discipline.
Contract Details
• Position: Quality Consultant / Lead
• Employment: Full-Time
• Location: Fully Remote
• Start: As soon as available
Ideal Candidate
- The ideal candidate is a senior GxP Quality/QA professional or consultant who can work independently,
communicate confidently with clients and internal stakeholders, and take ownership of QMS and regulatory compliance
- initiatives in a fast-moving technology environment.
Click on Apply to know more.
