Audit Director, Quality & Compliance
Scorpion Therapeutics, New Philadelphia, Pennsylvania, United States, 17959
Role Summary
Lead strategy, execution, and continuous improvement of the GxP audit program across clinical, manufacturing, laboratory, IT/CSV, vendor, and corporate compliance. Ensure global regulatory readiness (FDA, EMA, MHRA, Health Canada, and other authorities) as the company advances toward pivotal readiness, BLA submission, and commercialization. Manage and mentor the Audit Associate Director, provide strategic oversight of internal and external audits, ensure timely closure of observations and CAPAs, and partner cross‑functionally to strengthen inspection readiness.
Responsibilities
Audit Program Leadership
Develop and maintain the annual risk‑based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains.
Plan, schedule, and execute internal audits, vendor audits, and for‑cause audits.
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing.
Evaluate organizational risk and adjust audit scope and approach accordingly.
Management & Supervision
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development.
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards.
Support team succession planning and capability building as the audit function grows.
Audit Execution & Reporting
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT).
Oversee vendor and third‑party audits to qualify and maintain GxP suppliers.
Ensure timely issuance of audit reports, management responses, and CAPA plans.
Track, trend, and monitor CAPA effectiveness and timely closure.
Inspection Readiness
Partner with CMR, CMC, and Quality teams to drive enterprise‑wide inspection readiness for FDA, EMA, and other regulatory agencies.
Identify systemic issues and organizational risks through audits and propose proactive mitigation strategies.
Serve as a subject matter expert during inspections, helping teams respond to regulatory requests and remediation activities.
Governance & Continuous Improvement
Maintain and enhance audit‑related SOPs, templates, and quality processes.
Provide regular updates to Chief Compliance Officer and operational leadership team, governance committees as required.
Lead quality risk assessments and feed critical risks into the enterprise risk management framework.
Contribute to QMS improvements to support operational excellence and commercial readiness.
Cross‑Functional Collaboration
Partner with CMR, CMC, Manufacturing, Translational Sciences, IT, Regulatory, and Legal to ensure alignment on compliance expectations.
Serve as a trusted advisor on GxP compliance and risk.
Support training initiatives and lessons learned from audits.
Qualifications
Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline.
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment.
Demonstrated experience leading internal and external GxP audits.
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP).
Experience supervising or mentoring employees.
Strong analytical, organizational, and communication skills.
Ability to manage competing priorities in a fast‑paced, rapidly growing company.
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred.
Experience preparing for and supporting regulatory inspections preferred.
Certifications such as ASQ, RQAP‑GCP/GMP, RAC, CQA, or equivalent preferred.
Experience with QMS systems preferred.
Skills
Leadership & Coaching: Ability to develop talent and build a high‑performing audit function.
Risk‑Based Thinking: Ability to evaluate and prioritize risks in a complex scientific environment.
Independence & Integrity: Demonstrates strong ethical judgment and objective decision‑making.
Communication: Clear, concise communication tailored to all organizational levels, including executive leadership.
Collaboration: Works seamlessly across cross‑functional teams.
Adaptability: Thrives in a dynamic environment shifting toward commercial readiness.
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Responsibilities
Audit Program Leadership
Develop and maintain the annual risk‑based Internal Audit Program across GCP, GMP, GLP, IT/CSV, and Quality Management System (QMS) domains.
Plan, schedule, and execute internal audits, vendor audits, and for‑cause audits.
Ensure alignment with global regulatory requirements and industry best practices for advanced therapies and cell therapy manufacturing.
Evaluate organizational risk and adjust audit scope and approach accordingly.
Management & Supervision
Directly supervise the current audit team member including goal setting, workload planning, performance management, and professional development.
Provide coaching, technical training, and oversight to ensure audit readiness and consistent application of audit standards.
Support team succession planning and capability building as the audit function grows.
Audit Execution & Reporting
Lead or oversee audits of internal functional areas (e.g., Clinical Operations, CMC, MSAT, Manufacturing, Quality Control, Regulatory Affairs, IT).
Oversee vendor and third‑party audits to qualify and maintain GxP suppliers.
Ensure timely issuance of audit reports, management responses, and CAPA plans.
Track, trend, and monitor CAPA effectiveness and timely closure.
Inspection Readiness
Partner with CMR, CMC, and Quality teams to drive enterprise‑wide inspection readiness for FDA, EMA, and other regulatory agencies.
Identify systemic issues and organizational risks through audits and propose proactive mitigation strategies.
Serve as a subject matter expert during inspections, helping teams respond to regulatory requests and remediation activities.
Governance & Continuous Improvement
Maintain and enhance audit‑related SOPs, templates, and quality processes.
Provide regular updates to Chief Compliance Officer and operational leadership team, governance committees as required.
Lead quality risk assessments and feed critical risks into the enterprise risk management framework.
Contribute to QMS improvements to support operational excellence and commercial readiness.
Cross‑Functional Collaboration
Partner with CMR, CMC, Manufacturing, Translational Sciences, IT, Regulatory, and Legal to ensure alignment on compliance expectations.
Serve as a trusted advisor on GxP compliance and risk.
Support training initiatives and lessons learned from audits.
Qualifications
Bachelor’s degree in Life Sciences, Quality, Regulatory, or related discipline.
10+ years of GxP audit experience in biotechnology, pharmaceutical, or cell therapy environment.
Demonstrated experience leading internal and external GxP audits.
Strong understanding of FDA, EMA, MHRA, and ICH regulations (including ICH E6 R3, Annex 1, 21 CFR Parts 210/211/312/820, GCP/GMP/GLP).
Experience supervising or mentoring employees.
Strong analytical, organizational, and communication skills.
Ability to manage competing priorities in a fast‑paced, rapidly growing company.
Experience in advanced therapies, ATMPs, or cell/gene therapy manufacturing preferred.
Experience preparing for and supporting regulatory inspections preferred.
Certifications such as ASQ, RQAP‑GCP/GMP, RAC, CQA, or equivalent preferred.
Experience with QMS systems preferred.
Skills
Leadership & Coaching: Ability to develop talent and build a high‑performing audit function.
Risk‑Based Thinking: Ability to evaluate and prioritize risks in a complex scientific environment.
Independence & Integrity: Demonstrates strong ethical judgment and objective decision‑making.
Communication: Clear, concise communication tailored to all organizational levels, including executive leadership.
Collaboration: Works seamlessly across cross‑functional teams.
Adaptability: Thrives in a dynamic environment shifting toward commercial readiness.
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