Executive Director, GMP Quality Assurance

About the role

Bamboohr is seeking a highly experienced Executive Director of GMP Quality Assurance to lead our quality assurance initiatives in the rapidly evolving field of gene therapy. This pivotal role will be responsible for ensuring that our products meet the highest standards of quality and compliance with regulatory requirements. The ideal candidate will have a strong background in Good Manufacturing Practices (GMP) and a proven track record of managing quality assurance teams in a biopharmaceutical setting. This position is based in San Diego, California, and offers an exciting opportunity to contribute to innovative therapies that can significantly impact patients' lives.

Key facts

What you'll do

• Lead the development and implementation of quality assurance strategies that align with Bamboohr's mission and regulatory requirements.
• Oversee the quality management system (QMS) to ensure compliance with GMP, GLP, and GCP regulations.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to establish quality standards and processes.
• Manage and mentor a team of quality assurance professionals, fostering a culture of continuous improvement and accountability.
• Conduct regular audits and inspections of manufacturing facilities and processes to ensure adherence to quality standards.
• Develop and maintain relationships with regulatory agencies, ensuring timely communication and resolution of any compliance issues.
• Review and approve validation protocols, change controls, and quality-related documentation to ensure compliance with internal and external standards.
• Lead investigations of quality incidents, deviations, and non-conformances, implementing corrective and preventive actions as necessary.
• Provide training and guidance to staff on quality assurance practices and regulatory requirements.
• Monitor industry trends and regulatory changes to ensure Bamboohr remains at the forefront of quality assurance practices.
• Prepare and present quality metrics and reports to senior management and stakeholders, highlighting areas for improvement and compliance status.
• Participate in the development of strategic plans and initiatives to enhance the overall quality culture within the organization.

Requirements

• A minimum of 10 years of experience in quality assurance within the biopharmaceutical or biotechnology industry, with at least 5 years in a leadership role.
• In-depth knowledge of GMP, GLP, and GCP regulations and guidelines.
• Proven experience in managing quality assurance teams and driving a culture of quality throughout an organization.
• Strong understanding of the drug development process, including clinical trials and commercial manufacturing.
• Excellent analytical and problem-solving skills, with the ability to make data-driven decisions.
• Exceptional communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
• A Bachelor's degree in a relevant scientific discipline; advanced degrees (Master's or PhD) are preferred.
• Strong project management skills, with the ability to prioritize and manage multiple projects simultaneously.
• Experience with regulatory submissions and inspections is highly desirable.

Nice to have

• Certification in quality management (e.g., ASQ Certified Quality Auditor, Six Sigma) is a plus.
• Familiarity with electronic quality management systems (eQMS) and other quality-related software tools.
• Experience in gene therapy or advanced therapy medicinal products (ATMPs) is advantageous.
• Previous experience in a start-up environment or small to mid-sized companies is a plus.

Skills & tools

• Proficient in quality management software and tools for tracking quality metrics and compliance.
• Strong knowledge of statistical analysis and quality control methodologies.
• Familiarity with risk management principles and tools in a quality assurance context.
• Ability to utilize project management software to track progress and manage timelines effectively.

Practical notes

• This position is based in San Diego, California, and may require occasional travel to manufacturing sites or regulatory agencies.
• The salary for this role is competitive and will be determined based on the candidate's experience and qualifications.
• Bamboohr is committed to fostering a diverse and inclusive workplace and encourages applicants from all backgrounds to apply.

META

Company: Bamboohr

Title: Executive Director, GMP Quality Assurance

Listed

location: San Diego, California

Job type: Full-time

Apply URL: https://artivabio.bamboohr.com/careers/221

Tags: Director, QA