QA/QC Manager for In Vivo Research Facility (GLP Compliance Journey)
Bi-Lingual English/Spanish requirement
We represent a visionary research organization dedicated to advancing scientific discovery and innovation. Our mission is to bridge the gap between research and real-world applications, focusing on transformative solutions in the field of translational medicine that improve human health and well-being. As we embark on our journey to achieve Good Laboratory Practice (GLP) compliance, we are seeking a proactive and skilled QA/QC Manager to guide us in aligning our processes with FDA regulations, including 21CFR Part 11.
Join our team as the QA/QC Manager and be an instrumental part of our transformation towards GLP compliance. As the driving force behind our Quality Assurance (QA) and Quality Control (QC) efforts, you will play a critical role in ensuring that our research activities, documentation, and data uphold the highest standards of integrity, quality, and compliance with regulatory requirements.
– Collaborate closely with cross-functional teams to develop and implement comprehensive QA/QC strategies, processes, and Standard Operating Procedures (SOPs) in line with GLP principles and FDA regulations, including 21CFR Part 11.
– Conduct routine assessments and audits of research activities, documentation, and data to identify opportunities for improvement to meet GLP standards and compliance objectives.
– Lead the design and implementation of a robust data integrity program, encompassing audit trails, electronic signatures, data validation, and security controls, ensuring adherence to 21CFR Part 11 guidelines.
– Establish and deliver training programs that educate research staff about GLP principles, FDA regulations, and the significance of compliance, fostering a culture of awareness and accountability.
– Collaborate with our dynamic IT and software development teams to evaluate, enhance, and implement electronic systems and software applications that align with 21CFR Part 11 requirements for data capture, analysis, and reporting.
– Monitor emerging trends in regulatory compliance, GLP guidelines, and 21CFR Part 11 updates to drive ongoing enhancement and alignment of QA/QC practices.
– Participate in the planning and execution of internal audits, aiding in addressing findings and executing 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.
– Bachelor’s or Master’s degree in a relevant scientific field (Biology, Pharmacology, etc.) or equivalent practical experience.
– Bilingual English/Spanish (30% Spanish speaking employees)
– 5-15 years of experience in QA/QC roles within scientific research, with a demonstrated emphasis on quality assurance and compliance advancement.
– Familiarity with GLP principles, FDA regulations, and a keen interest in learning and implementing 21CFR Part 11 requirements.
– Exceptional communication and interpersonal skills, enabling effective collaboration across 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, evolving environment, embracing the challenges and rewards of our compliance journey.
– A unique opportunity to be a catalyst for positive change in our pursuit of GLP compliance.
– Competitive compensation package reflective of your experience and expertise.
– Ongoing professional development and training to foster 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.