Sr. Manager Quality Audit and Compliance

Scorpion Therapeutics; San Francisco Caballúa; Híbrido; MXN 1,390,000 - 1,913,000; Jornada completa

Descripción de la vacante

A biopharmaceutical company in Oaxaca is seeking a Senior Manager, Quality Audits to lead internal and external audits compliant with GMP and GxP regulations. This role requires significant experience in quality assurance, with proven expertise in conducting audits and developing quality agreements. The ideal candidate will possess strong communication skills and a deep understanding of compliance processes within pharmaceutical operations. The position includes travel domestically and internationally, approximately 25-30% of the time.

Formación

• Minimum of 6 years of experience in quality assurance (QA), including 3 years in GMP QA.
• Extensive knowledge of GMP QA program guidelines.
• ASQ or ECA certification is a plus.

Responsabilidades

• Conduct and oversee internal and external GMP/GxP compliance audits.
• Prepare and track audit reports and maintain audit program.
• Develop and negotiate quality agreements with CSPs.
• Provide GMP compliance advisory support.
• Lead continuous improvement initiatives in compliance with regulations.

Conocimientos

Quality management best practices

GMP regulations

Internal audits experience

Effective communication

Collaboration skills

Educación

Bachelor’s degree in Life Sciences or related field

Descripción del empleo

Role Summary

The Senior Manager, Quality Audits is responsible for leading and executing internal and external audits across Acadia’s expanding portfolio. This role plays a critical part in ensuring compliance with GMP and GxP regulations, maintaining robust Quality Agreements, and supporting the ongoing effectiveness and continuous improvement of Acadia’s Quality Management System. The position serves as a subject matter expert for audit readiness, regulatory compliance, and quality system optimization across clinical and commercial operations. This position can be based in San Diego, CA or Princeton, NJ or San Francisco, CA. Acadia's hybrid model requires this role to work in our office three days per week on average.

Responsibilities

• Plan, coordinate, schedule, and conduct internal and external GMP/GxP compliance audits, ensuring CSPs meet Acadia standards and all applicable FDA, EU (EudraLex), Canadian, and international regulatory requirements
• Prepare, review, issue, and track audit reports and observations to closure; compile, analyze, and present audit metrics and trends to support management review
• Develop, review, negotiate, and maintain quality agreements with clinical and commercial CSPs
• Maintain and continuously improve the internal audit program, including coordination of GxP audit activities with internal and external stakeholders
• Prepare, review, format, and maintain SOPs, and recommend or implement policy and procedural changes that may impact departmental or company-wide operations
• Provide GMP compliance expertise and advisory support, including support for annual product reviews, mock recalls, field alerts, and actual recall events
• Support the selection, implementation, validation, and continuous improvement of quality system–related computerized systems, including CSV support as needed
• Lead and support continuous improvement initiatives aligned with GMP and industry best practices, while ensuring compliance with company policies, including Privacy/HIPAA and other legal requirements
• Other duties as assigned

Qualifications

• Bachelor’s degree in a Life Sciences or related field. An equivalent combination of education and applicable job experience may be considered.
• Targeting 6 years of progressively responsible experience within quality assurance (QA), including 3 years directly responsible for GMP QA, with knowledge of external and internal auditing.
• Extensive knowledge of guidelines and international regulations that affect the GMP QA programs.
• ASQ or ECA academy certification, and/or European Lead Auditor experience is a plus.

Skills

• In-depth understanding of quality management best practices within the pharmaceutical or biopharmaceutical industry
• Demonstrated expertise in QA activities and GMP regulations (FDA, EU, ICH) across clinical development, manufacturing, technology transfer, and commercial operations
• Strong ability to interpret and apply U.S. and international cGMP requirements
• Proven experience conducting internal audits, supplier audits, and manufacturing site inspections
• Ability to translate quality standards into practical implementation and review activities
• Clear, effective communicator with experience presenting technical and compliance-related information to cross-functional audiences
• Strong collaboration skills with the ability to influence and gain cooperation across functions
• Willingness to travel domestically and internationally (approximately 25–30%)

Education

• Bachelor’s degree in a Life Sciences or related field. An equivalent combination of education and applicable job experience may be considered.

Additional Requirements

• Travel domestically and internationally (approximately 25–30%)