Director of cGMP Compliance Consulting
Remote – United States – Full-Time Position
Company Overview
Accorto Regulatory Solutions is a fully-remote, boutique regulatory and compliance firm whose mission is to help small to mid-sized domestic and international companies bring FDA-regulated products to market through innovative, cost-effective regulatory application strategies. We ensure our clients’ products remain on the market by focusing on continued regulatory compliance throughout the product lifecycle. Our expertise in navigating the FDA’s complex processes helps entrepreneurs and companies without in-house regulatory staff (or who need additional regulatory resources), as well as overseas companies, successfully enter the US market.
In addition to our regulatory application expertise, we provide comprehensive support in cGMP compliance to our clients across a range of FDA-regulated industries. Our team assists clients in building and maintaining quality systems, preparing for FDA inspections, and ensuring adherence to evolving regulatory requirements. By integrating regulatory strategy with cGMP compliance, we deliver a full-spectrum approach that safeguards product quality, strengthens market readiness, and supports long-term success.
Position Overview
We are seeking a Director of cGMP Compliance Consulting to establish and lead our consulting group focused on regulatory compliance in the pharmaceutical, biotechnology, and medical device industries. Reporting directly to the executive team, this individual will be directly responsible for fine-tuning the company’s value proposition in this market segment, building the technical project execution team, assisting the commercial team in assessing and quoting commercial opportunities, delivering client engagements based on an existing and growing pipeline of commercial opportunities, and serving as a trusted advisor for clients navigating complex global regulatory frameworks. The Director will be a player-coach, leading projects while also mentoring and growing the consulting team in this market segment.
Key Responsibilities:
• Lead client engagements, including audits, gap analyses, risk assessments, and remediation planning.
• Build and manage a team of consultants that is scaled and skilled to meet the existing and forecasted commercial volume, providing coaching and technical oversight.
• Develop and implement best practices, SOPs, and tools for effective and efficient compliance consulting.
• Stay current with FDA, EMA, ICH, and other global regulatory updates, ensuring clients receive the most relevant guidance.
• Contribute to business development by supporting proposals, scoping projects, and building client relationships.
• Deliver training sessions and workshops for clients on cGMP compliance topics.
Required Skills and Qualifications:
• Bachelor’s or master’s degree in Life Sciences, Engineering, Regulatory Science, or related discipline.
• 8–12 years of industry or consulting experience in pharmaceutical/biotech/medical device cGMP compliance.
• Direct experience conducting audits, remediations, and regulatory inspections.
• Strong leadership skills with a hands-on, collaborative style.
• Excellent communication and client-facing skills.
• Ability to travel up to 25% of the time.
Ideal Candidate:
•Enjoys being hands-on while building a practice from the ground up.
• Thrives in fast-moving environments where adaptability is key.
• Has the ability to transition from leading technical work to managing client relationships seamlessly.
Accorto Regulatory Solutions is committed to creating a diverse environment and is proud to be an equal opportunity employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or other characteristics.
