Associate Director, GLP/GCP Quality Audits and ComplianceScorpion Therapeutics • Oaxaca de Juárez, Oaxaca, Mexico

Associate Director, GLP / GCP Quality Audits and Compliance

Scorpion Therapeutics • Oaxaca de Juárez, Oaxaca, Mexico

Hace 6 días

Tipo de contrato

Teletrabajo

Descripción del trabajo

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

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Associate Director GLPGCP Quality Audits and Compliance • Oaxaca de Juárez, Oaxaca, Mexico

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