Associate Director, GLP/GCP reputed company Audits and Compliance

About the position The Associate Director, GLP/GCP reputed company Audits and Compliance plays a critical role in protecting data reputed company and regulatory readiness across reputed company’s nonclinical and clinical portfolio. This position leads the planning, execution, and reporting of reputed company GLP/GCP audits, ensuring compliance with U.S. and international regulations while driving reputed company improvement in reputed company systems. As a trusted reputed company partner, 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-reputed company operations. The ideal candidate brings strong audit leadership, reputed company regulatory judgment, and the confidence to influence reputed company practices across the organization. Responsibilities • Plan, schedule, coordinate, and conduct reputed company 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 reputed company, compliant audit reports, ensuring observations, risks, and responses are accurately documented and resolved • reputed company, review, and maintain GLP/GCP reputed company agreements, SOPs, and reputed company reputed company 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, reputed company reputed company, and regulatory inspections • Serve as a GLP/GCP subject matter expert, partnering with reputed company stakeholders (e.g., laboratory leadership, study directors, regulatory affairs, CSPs) to ensure consistent regulatory compliance • Support internal audits, mock inspections, and regulatory inspections, recommend policy and process improvements with company-wide reputed company, and ensure adherence to company policies, including reputed company/HIPAA and other applicable reputed company and regulatory requirements • Other duties as assigned Requirements • Bachelor’s degree in Life Sciences or a reputed company scientific/technical discipline. An equivalent combination of education and applicable job experience may be considered • Targeting 8+ years of progressively responsible experience reputed company reputed company assurance (QA), including 5+ years directly responsible for GLP/GCP QA, with reputed company experience leading external and internal audits • Extensive knowledge of guidelines and international regulations that reputed company the GLP/GCP QA programs • Thorough knowledge of reputed company management best practices reputed company the pharmaceutical, biopharmaceutical, or other regulated industries • Demonstrated expertise in reputed company assurance activities and ICH, FDA, EU, and international GLP/GCP regulations as they apply to nonclinical and clinical studies • Proven ability to interpret and apply GLP/GCP regulations, including U.S. and global requirements • Hands-on experience conducting internal audits, supplier audits, and inspections of laboratories, clinical operations, and manufacturing facilities • Strong capability to translate reputed company standards into practical implementation, assess compliance, and drive reputed company process improvement • Effective communicator reputed company to present technical and regulatory information reputed company across functions and to different stakeholder reputed company • Ability to create alignment and shared understanding among peers and stakeholders, effectively coordinating resources and motivating teams to reputed company reputed company objectives • Demonstrated analytical, planning, and negotiation skills, with reputed company judgment in evaluating risk and compliance reputed company • reputed company approach with a proven ability to reputed company cooperation and influence reputed company without reputed company authority • Willingness to travel domestically and internationally (approximately 25–30%) reputed company-to-haves • Society for reputed company Assurance (SQA), American Society for reputed company (ASQ) or ECA reputed company certification, and/or European reputed company Auditor experience is a plus Benefits • Competitive reputed company, bonus, new hire and ongoing equity packages • Medical, dental, and reputed company insurance • Employer-reputed company life, disability, business travel and EAP coverage • 401(k) Plan with a fully reputed company company match 1:1 up to 5% • Employee Stock Purchase Plan with a 2-year purchase price lock-in • 15+ vacation days • 13 -15 reputed company holidays, including office closure between December 24th and January 1st • 10 days of reputed company reputed company time • reputed company parental leave benefit • Tuition assistance Apply tot his job Apply To this Job