Associate Director, GLP/GCP Quality Audits and Compliance

Scorpion Therapeutics; Oaxaca de Juárez; Híbrido; MXN 1,738,000 - 2,261,000; Jornada completa

Descripción de la vacante

A leading biotechnology company in Oaxaca, Mexico seeks an Associate Director for GLP/GCP Quality Audits and Compliance. Your role will include planning and executing audits, ensuring compliance with regulations, and providing expert guidance. Candidates should possess over 8 years of QA experience including GLP/GCP QA, and a Bachelor’s degree in Life Sciences or related field. This hybrid role requires regular in-office presence and occasional travel domestically and internationally.

Formación

• 8+ years of QA experience, including 5+ years in GLP/GCP QA.
• Extensive knowledge of GLP/GCP guidelines and international regulations.
• Certification such as SQA, ASQ, or ECA is a plus.

Responsabilidades

• Plan and conduct GLP/GCP audits for company functions.
• Own the audit lifecycle, including preparation and reporting.
• Compile, analyze, and trend audit metrics.

Conocimientos

Quality management practices

ICH, FDA, EU regulations

Communication skills

Analytical skills

Continuous process improvement

Team coordination

Educación

Bachelor’s degree in Life Sciences

Descripción del empleo

Role Summary

The Associate Director, GLP/GCP Quality Audits and Compliance plays a critical role in protecting data integrity and regulatory readiness across the company’s nonclinical and clinical portfolio. This position leads the planning, execution, and reporting of internal and external GLP/GCP audits, ensuring compliance with U.S. and international regulations while driving continuous improvement in quality systems. This role provides expert guidance on GLP/GCP compliance, supports regulatory inspections, and works closely with internal teams and Contract Service Providers (CSPs) to maintain inspection-ready operations. The position can be based in San Diego, CA; Princeton, NJ; or San Francisco, CA, with a hybrid model requiring in-office work three days per week on average.

Responsibilities

• Plan, schedule, coordinate, and conduct internal and external GLP/GCP and GCP audits of company functions and Contract Service Providers (CSPs) in accordance with company standards and global regulatory requirements
• Own the end-to-end audit lifecycle, including audit preparation, execution, documentation, reporting, follow-up, and verification of corrective and preventive actions
• Prepare, review, and approve clear, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolved
• Develop, review, and maintain GLP/GCP quality agreements, SOPs, and related quality documentation supporting nonclinical and clinical activities
• Maintain, manage, and continuously improve the internal GLP/GCP audit program, ensuring ongoing inspection readiness
• Compile, analyze, and trend audit metrics to support management review, quality oversight, and regulatory inspections
• Serve as a GLP/GCP subject matter expert, partnering with internal and external stakeholders to ensure consistent regulatory compliance
• Support internal audits, mock inspections, and regulatory inspections, recommend policy and process improvements with company-wide impact, and ensure adherence to company policies, including Privacy/HIPAA and other applicable legal and regulatory requirements
• Other duties as assigned

Qualifications

• Bachelor’s degree in Life Sciences or a related scientific/technical discipline (equivalent combination of education and experience may be considered)
• 8+ years of progressively responsible QA experience, including 5+ years directly responsible for GLP/GCP QA, with direct experience leading external and internal audits
• Extensive knowledge of guidelines and international regulations affecting GLP/GCP QA programs
• Certification such as SQA, ASQ, or ECA academy is a plus; European Lead Auditor experience is a plus

Skills

• Thorough knowledge of quality management practices in pharmaceutical, biopharmaceutical, or other regulated industries
• Expertise in ICH, FDA, EU, and international GLP/GCP regulations as they apply to nonclinical and clinical studies
• Ability to interpret and apply GLP/GCP regulations across U.S. and global requirements
• Hands-on experience conducting internal audits, supplier audits, and inspections of laboratories, clinical operations, and manufacturing facilities
• Ability to translate quality standards into practical implementation, assess compliance, and drive continuous process improvement
• Strong communication skills to present technical and regulatory information across functions and stakeholder groups
• Ability to align and coordinate resources, motivate teams, and achieve quality objectives
• Analytical, planning, and negotiation skills with sound judgment on risk and compliance impact
• Collaborative approach with a proven ability to gain cooperation and influence outcomes without direct authority
• Willingness to travel domestically and internationally (approximately 25–30%)

Education

• Bachelor’s degree in Life Sciences or related discipline (or equivalent)
• Education and experience aligning with GLP/GCP QA programs; professional certifications are a plus

Additional Requirements

• Regular in-office presence required three days per week as part of a hybrid arrangement
• Travel domestically and internationally as part of audits and regulatory inspections
• Must meet essential job functions, including ability to endure travel and occasional after-hours work as travel schedules demand