Careers

Job Description:

We are seeking a highly-skilled and motivated individual to join our team as the Director of GLP Quality Control. Located in Carlsbad, CA, you will play a crucial role in ensuring the highest standards of quality and compliance with regulatory requirements in our In Vivo Research Facility.

Company Overview:

At our visionary research organization, we are dedicated to advancing scientific discovery and innovation. Our mission is to bridge the gap between research and real-world applications, with a focus on translational medicine that improves human health. As we strive to achieve GLP compliance, we need a proactive Director of GLP Quality Control to guide us in aligning our processes with FDA regulations, including 21CFR Part 58.

Position Overview:

Join us as the Director of GLP Quality Control and make a significant impact on our journey towards compliance. In this role, you will be responsible for overseeing our Quality Assurance (QA) and Quality Control (QC) efforts, ensuring that our research activities, documentation, and data maintain the highest level of integrity, quality, and compliance.

Responsibilities:

- Collaborate closely with cross-functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures (SOPs) in accordance with GLP principles and FDA regulations, including 21CFR Part 58.

- Conduct regular assessments and audits of research activities, documentation, and data to identify areas for improvement in meeting GLP standards and compliance objectives.

- Lead the design and implementation of a robust data integrity program, including audit trails, electronic signatures, data validation, and security controls, ensuring adherence to 21CFR Part 58 guidelines.

- Develop and deliver training programs to educate research staff on GLP principles, FDA regulations, and the importance of compliance, fostering a culture of awareness and accountability.

- Work closely with our IT and software development teams to evaluate, enhance, and implement electronic systems and software applications that align with the data capture, analysis, and reporting requirements of 21CFR Part 58.

- Stay informed about emerging trends in regulatory compliance, GLP guidelines, and updates to 21CFR Part 58 to continuously enhance and align our QA/QC practices.

- Participate in internal audit planning and execution, assisting in addressing findings and implementing corrective actions to improve compliance.

- Serve as a point of contact for regulatory agencies and external auditors during compliance inspections, facilitating the audit process and providing essential documentation.

Qualifications:

- A Master's degree in a relevant scientific field (Biology, Pharmacology, etc.) or equivalent practical experience.

- 5-15 years of experience in QA/QC roles within scientific research, with a strong emphasis on quality assurance and compliance.

- Familiarity with GLP principles, FDA regulations, and a keen interest in learning and implementing the requirements of 21CFR Part 58.

- Excellent communication and interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.

- Detail-oriented mindset with a passion for identifying opportunities for improvement and translating them into practical solutions.

- Ability to thrive in a fast-paced and evolving environment, embracing the challenges and rewards of our compliance journey.

What We Offer:

- An opportunity to be a catalyst for positive change in our pursuit of GLP compliance.

- Competitive compensation package based on your experience and expertise.

- Ongoing professional development and training to support your growth.

- A collaborative and innovative work environment that values your contributions.

If you are an enthusiastic QA/QC professional with a desire to shape the future of research quality and compliance, we encourage you to apply. Join us in our commitment to advancing scientific excellence and driving transformative solutions for the betterment of humanity.