Director, Global Audit Program (Remote - US)

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director, Global Audit Program in the United States.

In this role, you will lead the strategic direction, execution, and oversight of enterprise-wide audit programs, ensuring compliance with global regulatory requirements and internal quality standards. You will oversee internal and external GxP audits, partner audits, self-inspections, and audit-related documentation while driving continuous improvement in processes and systems. Collaborating with cross-functional teams across Quality, Technical Operations, Regulatory, and site-based Quality, you will ensure alignment, visibility, and preparedness for inspections and audits. The ideal candidate brings a strong track record of leadership, audit program management, and regulatory expertise, with the ability to influence and drive change across a global organization. This role offers a hybrid, onsite, or remote work option with a focus on U.S.-based candidates.

Accountabilities

·         Provide strategic leadership for internal and partner audit programs, including supplier/vendor audits, hosted audits, self-inspections, and GxP audits across development and commercial operations.

·         Develop, maintain, and execute an annual risk-based audit plan, incorporating internal priorities, partner expectations, and evolving regulatory trends.

·         Maintain awareness of regulatory expectations, industry trends, and inspection findings to continuously improve audit practices.

·         Collaborate with site-based Quality teams to coordinate audit logistics and ensure readiness for inspections.

·         Lead audits across multiple GxP domains (GMP, GDP, GCP, GLP), including planning, execution, reporting, and CAPA management.

·         Oversee audit-related systems, documentation, and workflows to ensure compliance and inspection readiness.

·         Contribute to auditor training and qualification, and lead audit-related metrics and reporting activities.

·         Drive continuous improvement initiatives to enhance audit processes, tools, and overall program effectiveness.

·         Bachelor’s degree in life sciences, pharmacy, or related field preferred; equivalent industry experience accepted.

·         Minimum of 10 years in pharmaceutical or biotechnology Quality Assurance with extensive GxP audit experience.

·         Demonstrated experience leading comprehensive audit programs, managing internal and external audits across multiple GxP areas.

·         Strong knowledge of global regulatory requirements (FDA, EMA, MHRA, ICH, PIC/S) and their application to audit programs.

·         Experience supporting inspections and partner audits, including coordination with site-based teams.

·         Excellent communication, collaboration, and cross-functional influencing skills.

·         Experience with electronic audit systems and quality management tools (e.g., Veeva, AuditUtopia) preferred.

·         Ability to travel domestically and internationally up to 10–15% as needed.

·         Competitive base salary: $187,000 - $253,000 annually, plus eligibility for annual short-term and long-term incentive awards.

·         Comprehensive health benefits including medical, dental, and vision coverage.

·         Life and disability insurance, flexible spending and health savings accounts.

·         401(k) retirement plan with company match.

·         Paid time off, wellness days, holidays, and company-wide recharge breaks.

·         Family support resources and generous leave programs.

·         Programs and initiatives to promote employee well-being and work-life balance.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias, focusing solely on your fit for the role. Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.

Thank you for your interest!

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