GCP Quality Consultant

Widler & Schiemann, LLC | Fully Remote (United States) |

At Widler & Schiemann, this role goes beyond a traditional auditor position. As a GCP Quality Consultant, you will act as both an auditor and a trusted advisor to biotech and pharmaceutical clients, supporting them in building fit-for-purpose, inspection-ready quality systems.

You will plan and conduct GCP audits - vendors, internal processes, and investigator sites - and contribute as a subject matter expert across clinical development and pharmacovigilance projects.

This is a fully remote role designed for professionals who value:

Flexibility over rigid structures

You'll work closely with a small, highly experienced, entrepreneurial team where ideas move quickly, ownership is real, and your expertise directly shapes how biotech companies grow and maintain compliance.

Remote-first, flexible working model. Work from where you are most productive.

Flat organization, high-trust environment. No unnecessary layers - direct collaboration with leadership and clients.

Entrepreneurial, close-knit culture. A small team that values quality, ownership, and mutual support.

Meaningful work with biotech innovators. Help early-stage and growing companies navigate clinical development and regulatory expectations.

Real development, not a training deck. You'll report directly to and work alongside two seasoned quality leaders - shadowing live audits, building documents together, and taking on more scope as you're ready.

Sustainable pace. Designed for professionals who value work-life balance while staying intellectually engaged.

Plan and execute GCP audits, including investigator sites, vendors, CROs, central labs, and internal processes

Serve as a subject matter expert on clinical quality and compliance consulting projects

Interpret and apply international regulations including ICH GCP, GVP, FDA, and EMA requirements

Conduct gap assessments, risk evaluations, and HA inspection readiness activities, including simulated FDA and EMA inspections

Support clients in managing deviations, CAPAs, and quality events with pragmatic, compliant solutions

Contribute to the development and improvement of quality systems, SOPs, and governance frameworks

Provide advisory support to biotech clients on scalable, risk-based quality approaches

Work directly with biotech and pharmaceutical clients from day one

Stay current with industry trends, digital tools, and regulatory expectations, bringing practical insights to clients

Grow into broader consulting responsibilities over time

This role is ideal for someone who:

Enjoys working independently while staying connected to a collaborative team

Prefers substance over corporate titles or hierarchy

Finds motivation in helping biotech companies succeed

Values flexibility, autonomy, and trust in how work gets done

Takes pride in delivering high-quality, practical solutions, not just theoretical compliance

Finds a small, flat, remote environment liberating rather than overwhelming

Approximately 3-5 years of experience in a GCP environment

Hands-on clinical research or clinical quality experience (e.g., CRA, Clinical Project Manager, QA Auditor)

Demonstrated hands-on audit experience - you have conducted audits, not just supported them

Foundation in quality management, clinical research, or regulatory affairs

Strong understanding of global regulations (ICH GCP, FDA, EMA)

Strong writing and documentation skills; findings and recommendations are anchored in writing

Proven ability to manage client relationships and deliver work independently

Strong communication, analytical, and problem-solving skills

Ability to translate regulatory requirements into practical, scalable solutions

Comfortable working independently in a small, flat, remote environment

Willingness to travel when an audit or activity requires on-site access

Experience leading GCP audits in an international setting

Experience in additional GxP areas (GLP, CSV)

Interest in contributing to proposals, client engagements, or knowledge sharing

Bachelor's degree or higher in life sciences, pharmacy, biotechnology, nursing, or a related field

Additional certifications or training in GCP, GVP, or Computerized Systems Validation (CSV) are advantageous

This is a home-based, fully remote position within the United States

Travel is project-driven, planned in advance, and by request when an on-site is required. We don't make…