Quality Assurance Director

This is a fully remote position, open to applicants in Arizona, +8 more states.

📋 Description

• Act as a senior advisor and delivery leader for strategic quality and regulatory initiatives.

• Oversee the design and remediation of Quality Management Systems, ensuring inspection readiness, regulatory responses, data integrity, risk management, compliance transformation, quality governance, investigations, submission support, supplier quality audits, new product introductions, and regulatory strategy projects.

• Create and conduct training sessions and workshops.

• Focus on complex strategic projects while ensuring excellence in delivery, adherence to regulatory standards, and optimal client outcomes.

• Maintain a high level of billable utilization and travel for client projects, executive workshops, audits, and regulatory engagements.

• Serve as the project sponsor or senior engagement leader, directing the scope, approach, and client communication.

• Assist in sales, business development, proposal creation, scope definition, pricing input, and client presentations.

• Discover opportunities to enhance existing engagements.

• Generate thought leadership materials such as white papers, frameworks, case studies, and internal methodologies.

• Represent Project Farma at industry events, conferences, webinars, and professional organizations.

• Keep abreast of regulatory changes and expectations in the US, EMA, and ROW.

• Mentor and coach consultants and project Directors.

• Provide technical and professional guidance while supporting talent development.

• Collaborate with Regional VPs, Client Engagement, and Client Solutions teams.

• Assist in practice planning, capability development, and the evolution of service lines.

• Contribute to firmwide initiatives that require quality and regulatory expertise.

⛳️ Requirements

• A bachelor's degree in a scientific, regulatory, engineering, or a related field is preferred.

• 16 years of experience for the Director position, or 20 years for the Senior Director role, in life sciences quality, compliance, or regulatory positions, which includes consulting and/or leadership on the owner side.

• Proven track record in delivering and advising on complex GxP, regulatory, and quality system projects.

• Strong understanding of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO).

• Demonstrated capability to support sales and business development in a consulting environment.

• Executive presence paired with excellent written and verbal communication skills.

• Willingness and capability to travel frequently to support project delivery and client requirements.

• Previous experience in developing and delivering thought leadership, including conference presentations, white papers, and published articles.

• An advanced degree is preferred.

• One or more industry-specific certifications.

• Must have authorization to work in the United States on a full-time basis.

• No current or future sponsorship for work visas.

• Cannot hold employment with an invalid driver's license.

🏝️ Benefits

• Full-time salaried position.

• Opportunities for professional development.

• Mentorship and knowledge-sharing initiatives.

• A diverse and equal-opportunity work environment.