Senior Associate, QA Compliance

About the role

Artivabio is seeking a dedicated Senior Associate in Quality Assurance Compliance to join our dynamic team in San Diego, California. This position plays a crucial role in ensuring that our quality assurance processes meet regulatory standards and internal policies. The ideal candidate will have a strong background in quality assurance within the biotechnology or pharmaceutical sectors, with a focus on compliance and regulatory affairs. This is an exciting opportunity to contribute to innovative therapies while ensuring the highest standards of quality and safety.

Key facts

What you'll do

• Develop, implement, and maintain quality assurance policies and procedures to ensure compliance with regulatory requirements and industry standards.
• Conduct regular audits of internal processes and systems to identify areas for improvement and ensure adherence to established quality standards.
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality is integrated into all aspects of product development and lifecycle management.
• Review and approve validation protocols and reports, ensuring that all processes are adequately documented and compliant with regulatory expectations.
• Assist in the preparation and submission of regulatory documents, including IND and BLA submissions, ensuring all quality-related information is accurate and complete.
• Provide training and guidance to staff on quality assurance practices, regulatory compliance, and best practices in quality management.
• Investigate and resolve quality issues, including deviations and non-conformances, and implement corrective and preventive actions (CAPA) as necessary.
• Monitor industry trends and regulatory changes to ensure the company remains compliant and competitive in the market.
• Participate in external audits and inspections, serving as a key point of contact for regulatory agencies and ensuring all findings are addressed promptly.
• Maintain thorough documentation of quality assurance activities, including audit findings, training records, and compliance metrics.
• Support the development of quality metrics and reporting systems to track performance and drive continuous improvement initiatives.
• Foster a culture of quality and compliance throughout the organization, promoting awareness and accountability at all levels.

Requirements

• Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in quality assurance or compliance within the biotechnology or pharmaceutical industries.
• In-depth knowledge of FDA regulations, ICH guidelines, and other relevant regulatory requirements.
• Proven experience conducting audits and inspections, with a strong understanding of quality management systems (QMS).
• Excellent analytical and problem-solving skills, with the ability to interpret complex data and regulatory requirements.
• Strong communication skills, both verbal and written, with the ability to effectively convey information to diverse audiences.
• Detail-oriented with a commitment to maintaining high standards of quality and compliance.
• Ability to work independently and collaboratively in a fast-paced, team-oriented environment.
• Proficiency in quality management software and tools; experience with electronic document management systems (EDMS) is a plus.

Nice to have

• Certification in quality assurance or regulatory affairs (e.g., ASQ, RAC) is highly desirable.
• Experience in gene therapy or cell therapy development is a plus.
• Familiarity with risk management principles and methodologies in a quality context.
• Previous experience working with international regulatory agencies is advantageous.

Skills & tools

• Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and quality management software.
• Familiarity with statistical analysis tools and methodologies for quality control.
• Knowledge of electronic laboratory notebooks (ELN) and other digital tools used in quality assurance.

Practical notes

• This position is based in San Diego, California, and may require occasional travel for audits and inspections.
• The company offers a competitive salary and benefits package, including health insurance, retirement plans, and opportunities for professional development.
• Artivabio is committed to fostering a diverse and inclusive workplace; we encourage applications from individuals of all backgrounds and experiences.

If you are passionate about quality assurance and compliance in the biotechnology field and are looking for an opportunity to make a significant impact, we invite you to apply for the Senior Associate, QA Compliance position at Artivabio. Join us in our mission to develop groundbreaking therapies that improve patient outcomes and transform lives.