Job Details

Position Summary:
The Senior Quality Assurance Associate – GMP/GDP Auditing is responsible for executing GMP and GDP audits, supporting supplier qualification, compliance oversight, and inspection readiness activities across our external partner network. This role serves as a Quality Assurance subject matter expert for supplier audits, risk assessments, and external quality management, ensuring compliance with applicable regulatory requirements and company standards.

The position partners closely with Technical Operations, Supply Chain, Regulatory Affairs, Clinical Operations, Pharmacovigilance, and other cross-functional teams to support a robust supplier qualification and audit program.

Responsibilities:
GMP/GDP Auditing

• Conduct risk-based GMP and GDP audits of contract manufacturers, testing laboratories, distribution providers, logistics partners, and/or medical device manufacturers.
• Plan, execute, and document on-site, remote, and hybrid interna/external audits.
• Assess compliance with applicable FDA, EU, ICH, ISO, and other regulatory requirements.
• Prepare audit reports, observations, and risk assessments.
• Review supplier responses and evaluate corrective and preventive action (CAPA) plans.
• Track audit findings and quality actions through closure.
• Support audit schedule preparation, audit metrics, trending, and management reporting.
• Communicate significant audit findings and compliance risks to Quality leadership and relevant cross-functional stakeholders.

 
Supplier Qualification & Oversight

• Perform supplier qualification, requalification assessments and risk-based recommendations.
• Review supplier documentation, inspection histories, quality metrics, and compliance records.
• Maintain supplier qualification records, risk assessments, and Approved Supplier Lists (ASLs).
• Monitor supplier performance, quality events, change notifications and assess their potential impact on product quality, patient safety, and regulatory compliance.
• Escalate significant quality or compliance risks as appropriate.

 
Quality Systems & Compliance

• Support GxP inspection readiness activities.
• Utilize electronic Quality Management Systems (e.g., Veeva Vault Quality Suite) to manage quality events and actions.
• Support the development, revision, and maintenance of quality procedures, work instructions, and related documentation.
• Participate in regulatory inspections, partner audits, and due diligence activities.

 
Continuous Improvement

• Contribute to quality system enhancements and process improvement initiatives.
• Support departmental and cross-functional quality objectives.
• Perform additional duties as assigned.

 
Education/Experience Requirements: 

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, Chemistry, Biology, or a related scientific discipline required. Equivalent combination of education and applicable job experience may be considered.
• 5+ years of Quality Assurance experience within an FDA-regulated industry required.
• 3+ years of GMP and/or GDP auditing experience.
• Experience auditing pharmaceutical, biologic, medical device, and/or GxP service providers.
• Experience with supplier qualification, supplier oversight, and regulatory inspections.
• Experience with electronic Quality Management Systems; Veeva Vault Quality Suite preferred.
• Lead Auditor certification (ASQ, IRCA, Exemplar Global, or equivalent) preferred.

Additional Skills/Experience: 

• The ideal candidate will embody our core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Strong knowledge of U.S. and EU GMP/GDP regulations and industry standards.
• Demonstrated ability to evaluate compliance risks and make sound risk-based decisions.
• Excellent technical writing, communication, and organizational skills.
• Strong attention to detail and ability to manage multiple priorities.
• Ability to work independently and collaboratively in a virtual manufacturing environment.
• Effective relationship-building skills with internal stakeholders and external partners.
• Ability to travel 25-40% domestically and internationally. 
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

Target Base Pay Range:
$95,000.00 – $124,000.00