Director of QA GLP In Vivo Operations - 238589

Job Title:

Director of QA GLP In Vivo OperationsEmployment Type:

Full-Time, PermanentAbout the Company:A rapidly growing life sciences company specializing in preclinical services is looking for a

GLP QA Director

to join their team in San Diego. This exciting opportunity is perfect for a professional ready to take full ownership of a GLP program, from establishing policies and procedures to leading a team in a dynamic environment.Key Responsibilities:Establish, enforce, and maintain cGLP policies and procedures across all departments.Ensure compliance with regulations related to facilities, personnel, practices, and records.Provide strategic direction to leadership, focusing on goal alignment, continuous improvement, and best practices.Own all documents and reports produced by the QA team, ensuring compliance with industry standards.Analyze complex quality situations and effectively communicate issues and recommendations to various departments.Implement the Quality Assurance program independently, maintaining objectivity and ensuring its success.Alert senior leadership to critical risks and ensure thorough root cause analysis and CAPAs for non-compliance.Support investigational new drug (IND) applications and manage communications with regulatory authorities.Focus on team development through coaching and mentoring to build a high-performing QA team.Lead preparations for regulatory inspections and ensure inspection readiness at all times.Review final study reports to ensure accuracy, adherence to protocols, and proper documentation.Maintain written records of all QA responsibilities, ensuring they align with regulatory requirements.Collaborate with internal departments to align on quality principles and regulatory requirements.Key Requirements:Vivarium experience

(CRO industry experience required, with both small and large animal experience preferred).Bachelor’s degree

or higher in a Science-related field.Strong knowledge of

cGLP regulations

and practical experience in a vivarium environment.Familiarity with

quality management systems (QMS)

and conducting regulatory inspections.Ability to lead and develop a team effectively.Demonstrated experience preparing for regulatory inspections and overcoming challenges.Nice-to-Have Qualifications:Exposure to

large animal studies

in a vivarium.Knowledge of

GLP, GMP, and GxP regulations

and their application.Experience leading and building a GLP program from scratch within a growing organization.Why This Role is Unique:Ownership & Leadership:

Lead the GLP program from the ground up and make key decisions in the direction of the group.Career Growth:

Play a significant role in shaping the company’s future by developing and mentoring your own team.Impact:

Be at the forefront of regulatory compliance and quality assurance in a fast-paced CRO environment.Why Join Us?We offer the opportunity to make a tangible impact in a rapidly growing organization, where your expertise in GLP and regulatory compliance will be valued as we continue to expand. If you’re excited to take ownership of a quality assurance program and develop a strong team, we want to hear from you!

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