Position: Associate Director, Quality Assurance
Salary Range: $140k - $160k
Location: Carlsbad, CA (ON-SITE)
What You'll DoWe are seeking an experienced and collaborative Associate Director, Quality Assurance to lead our GLP Quality Assurance program at Pharmaron's Carlsbad preclinical research facility.
In this key leadership role, you will oversee quality systems, ensure regulatory compliance, and drive continuous improvement initiatives that support the successful execution of preclinical research programs.
You will lead a team of Quality Assurance professionals while partnering closely with scientific teams, site leadership, and clients to maintain the highest standards of quality and regulatory excellence.
Key Responsibilities- Lead, mentor, and develop a team of Quality Assurance professionals, fostering a culture of accountability, collaboration, and continuous improvement.
- Oversee the site's GLP Quality Assurance program, ensuring compliance with FDA 21 CFR Part 58, applicable OECD GLP principles, ISO 9001 requirements, and internal quality standards.
- Partner with scientific and operational leadership to promote a strong quality culture and integrate GLP best practices throughout site operations.
- Manage and continuously improve GLP quality systems, including auditing, deviations, change control, CAPA, risk assessments, and training.
- Oversee QA audits of GLP studies, including protocols, raw data, study conduct, and draft and final reports, ensuring findings are appropriately addressed.
- Lead client audits and regulatory inspections, ensuring inspection readiness, effective communication, and timely resolution of findings.
- Develop and execute internal audit programs to identify compliance risks, evaluate quality systems, and implement corrective and preventive actions.
- Ensure appropriate oversight and maintenance of the GLP Master Schedule, study documentation, and archival program.
- Monitor quality performance metrics, identify trends, and provide recommendations to site and executive leadership to drive operational excellence.
- Collaborate with scientific teams to ensure preclinical research activities and client deliverables meet applicable regulatory requirements and quality standards.
- Support vendor and supplier qualification programs, including GLP-related audits and quality assessments.
- Partner with clients to address quality-related matters, maintain compliance with applicable quality agreements, and support successful project execution.
- Champion continuous improvement initiatives that strengthen compliance, streamline processes, and enhance the effectiveness of site quality systems.
- Ensure adherence to established Standard Operating Procedures (SOPs) and applicable regulatory requirements.
What We're Looking For- Bachelor's degree in Biology, Life Sciences, Chemistry, or a related scientific discipline.
- Minimum of 10 years of experience in the pharmaceutical, biotechnology, or CRO industry within a regulated GxP environment.
- Demonstrated experience leading and developing Quality Assurance teams, with the ability to influence quality initiatives across multiple functions.
- Strong knowledge of GLP regulations, including FDA 21 CFR Part 58, OECD GLP principles, applicable ICH guidelines, and ISO 9001.
- Experience supporting preclinical safety and toxicology studies, pharmacology research, and in vivo pharmacokinetic (PK) studies.
- Proven experience managing quality systems, including deviations, CAPAs, change control, internal audits, and regulatory compliance.
- Experience preparing for and leading client audits and regulatory inspections.
- Strong problem-solving and decision-making skills, with the ability to identify compliance risks and implement effective solutions.
- Excellent interpersonal and communication skills, with the ability to collaborate effectively with scientific teams, leadership, and external clients.
- Strong organizational skills, attention to detail, and a proactive approach to continuous improvement.
Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:
- Comprehensive Medical, Dental & Vision Insurance with significant employer contributions
- 401(k) Retirement Plan with generous employer matching
- Generous Paid Time Off (PTO), Paid Sick Leave & Company Holidays to support work-life balance
- Employer-funded Health Savings Account (HSA) contributions (for eligible plans), plus Healthcare & Dependent Care Flexible Spending Accounts
- 100% Employer-paid Employee Life Insurance, AD&D, Short- and Long-Term Disability Insurance
- Employee Assistance Program (EAP), mental health resources, and wellness programs
- Family-friendly benefits, including fertility support and maternity resources
- Professional development and career growth opportunities within a leading global CRO/CDMO
How to Apply:Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
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