Senior Compliance Auditor
About The Position
The Senior Compliance Auditor is an on-site role based in Las Piedras, Puerto Rico, reporting to the Compliance Manager. The position ensures that Quality Systems, non-compliance investigations, and audit activities comply with current Good Manufacturing Practices (cGMPs), company procedures, FDA regulations, and applicable international standards. Serving as a compliance subject matter expert, the Senior Compliance Auditor leads internal audit activities, supports regulatory inspections, drives continuous improvement initiatives, and helps ensure the effectiveness of site quality metrics programs. The role coordinates the Site Quality Metrics Program, including data collection, analysis, trending, and reporting. It works with process owners and cross-functional partners to support accurate submissions, management reviews, compliance decisions, and follow-up actions. The position also collaborates with suppliers, consultants, regulatory authorities, and internal teams as needed.
Requirements
- Bachelor's degree in Natural Sciences.
- At least six years of experience in Quality Compliance and/or Regulatory Compliance within an FDA-regulated industry.
- Experience in pharmaceutical and/or OTC manufacturing environments.
- At least two years of GMP auditing experience.
- Experience working with controlled substances/products and knowledge of DEA regulations.
- Experience supporting regulatory inspections, investigations, internal and external audits, and Quality Systems activities.
- Experience with quality metrics collection, analysis, trending, and reporting.
- Strong knowledge of cGMP regulations, including 21 CFR Parts 11, 210, and 211.
- Knowledge of international regulatory requirements, including Europe, Canada, and China.
- Strong analytical, technical writing, presentation, and project management skills.
- Ability to influence stakeholders, lead cross-functional discussions, and work independently on complex compliance matters.
- Bilingual proficiency in English and Spanish.
- Proficiency in Microsoft Office applications.
Nice To Haves
- GMP Auditor Certification from a recognized pharmaceutical organization.
- Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) certification.
- Experience supporting supplier audits and regulatory inspections.
- Experience leading quality improvement and compliance initiatives within regulated manufacturing environments.
Responsibilities
- Lead and support internal audits, including serving as Lead Auditor when assigned.
- Conduct investigations related to Quality Systems and non-compliance events, ensuring timely resolution and appropriate corrective and preventive actions.
- Support regulatory inspections, supplier audits, and third-party assessments, maintaining inspection readiness and compliance.
- Present audit findings, evaluate responses, and track commitments through completion and documentation.
- Monitor quality trends, identify compliance risks, and recommend process improvements.
- Develop, revise, and maintain procedures and quality documentation.
- Participate in developing and implementing remediation plans resulting from audits, inspections, investigations, and quality events.
- Support cGMP training programs and promote a culture of quality and compliance.
- Coordinate the Site Quality Metrics Program, including data collection, analysis, trending, and reporting.
- Partner with process owners to ensure timely and accurate quality metrics submissions and evaluations.
- Prepare management review presentations and provide insights for quality and compliance decision-making.
- Monitor key quality indicators and ensure completion of follow-up actions from management reviews.
- Collaborate with Quality, Manufacturing, Regulatory Affairs, and other functional teams on compliance and continuous improvement initiatives.
- Partner with internal stakeholders to harmonize processes, improve operational effectiveness, and strengthen compliance performance.
- Interact with suppliers, consultants, and regulatory authorities as required.
Benefits
- Competitive benefit package.
- Paid company holidays.
- Paid vacation.
- Volunteer time.
- Learning and development opportunities.
- Kenvuer Impact Networks.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
