Associate Director / Auditor, Quality Compliance and Audits
Job Description
Team: Others
This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director / Auditor, Quality Compliance and Audits in United States.
This senior quality compliance role is responsible for ensuring independent oversight of global manufacturing and supply chain operations through comprehensive GMP and GDP auditing activities.
You will play a critical part in safeguarding product quality, patient safety, and regulatory compliance across internal sites and a wide network of external partners, including contract manufacturers, laboratories, suppliers, and distributors.
The role involves leading end-to-end audit processes, from planning and execution to reporting and CAPA evaluation, within a highly regulated pharmaceutical environment.
You will collaborate with cross-functional teams to assess risk, evaluate compliance gaps, and strengthen quality systems across multiple modalities and global operations.
In addition, you will contribute to continuous improvement initiatives, audit strategy development, and supplier qualification activities supporting business growth.
This position offers high visibility and impact within a global organization focused on delivering life-changing therapies.
Accountabilities:
- Lead and support global GMP and GDP audits across internal manufacturing sites and external partners, including CMOs, laboratories, suppliers, and distributors
- Manage the full audit lifecycle, including planning, scheduling, execution, reporting, and CAPA review and follow-up
- Develop risk-based audit strategies and agendas aligned with regulatory requirements and internal quality standards
- Collaborate with cross-functional stakeholders to gather business context and ensure effective and targeted audit execution
- Identify, document, and escalate compliance gaps, quality risks, and systemic issues to ensure timely resolution
- Support supplier qualification, due diligence assessments, and onboarding of new partners and technologies
- Contribute to the development and continuous improvement of audit procedures, tools, templates, and training materials
- Ensure consistency and quality in audit reporting, observation classification, and risk assessment
- Support audit metrics tracking and continuous improvement initiatives across the audit program
- Bachelor’s, Master’s, PharmD, or PhD in a scientific or technical discipline with 5–10+ years of relevant experience in GMP/GDP auditing
- Strong background in pharmaceutical or biotechnology manufacturing, quality systems, or regulatory compliance
- Proven experience conducting independent audits and supporting cross-functional audit teams in global environments
- Deep knowledge of GMP/GDP regulations, including FDA 21 CFR, EU EudraLex Volume 4, ICH guidelines, ISO, PIC/S, and compendial standards
- Strong understanding of pharmaceutical manufacturing, testing, and distribution across multiple dosage forms and technologies
- Experience with risk-based auditing methodologies and full audit lifecycle management
- Strong analytical and critical thinking skills with the ability to assess complex compliance and quality issues
- Excellent communication skills, including the ability to interact with technical, operational, and executive stakeholders
- Strong organizational skills with the ability to manage multiple priorities independently
- Leadership experience and ability to contribute to or lead cross-functional audit initiatives is highly desirable
- Competitive annual salary ranging from 165,495 to 214,170 USD depending on experience and location
- Eligibility for annual discretionary bonus and long-term incentive plans
- Comprehensive health coverage including medical, dental, vision, and life insurance
- Paid time off, holidays, and flexible leave options
- Equity in a globally recognized life sciences organization (where applicable)
- Remote or hybrid flexibility depending on role requirements
- Professional development opportunities and continuous learning support
- Inclusive and diverse work environment with strong employee support networks
Requirements:
Benefits:
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Date Posted
04/10/2026
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