The Senior Compliance Specialist maintains and continuously improves quality systems to ensure compliance with applicable FDA regulations (FDA 21CFR, 210, 211, 820 and 821), and other global regulatory standards. This role independently leads and manages customer, internal, and supplier audit activities, serving as a subject matter expert and process leader within the Quality organization.
Essential Duties and Responsibilities - Responsible for site coordination and execution of customer audits, including audit preparation, hosting, facilitation, response development, and closure to ensure commitments and due dates are met.
- Monitors and provides trend analysis and metrics of Quality Events, customer complaints, and change controls
- Act as back-up Management Representative for customer, FDA, and/ or other regulatory inspections.
- Leads the development, coordination, and submission of audit responses (customer, internal, and supplier), including corrective and preventive action plans
- Identify, drive, mentor, and implement projects that improve overall Operational quality
- Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships
- Plans, conducts, and independently manages internal audits and supplier audits in accordance with the established audit schedule, including reporting and follow-up of identified observations.
- Monitors, trends, and reports quality metrics related to audits and investigations, supplier complaints, and CAPAs related to audit actions.
- Actively supports and participates in site process improvement initiatives
- Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems
- Serve as a technical subject matter expert (SME) in support of department functions
- Train personnel and internal customers on relevant business processes
- Other duties as assigned.
QualificationsTo perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements listed below represent the knowledge, skill, and/or ability required.
- Bachelors' Degree, Associates Degree, or equivalent in science or technical related field preferred.
- Minimum 7 years relevant work experience in a cGMP environment
- Advanced knowledge of GMPs, GDPs, GLPs, Auditing and Quality Assurance/Quality Control skills and the ability to communicate this knowledge to the organization professionally and succinctly
- Demonstrated ability to lead audit activities and compliance initiatives independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, strong attention to detail and excellent organizational skills.
- Experience with Microsoft Office applications and quality management systems
- The ability to make sound regulatory interpretation, employ logic, and implement decisions from within the QA organization
- Demonstrated ability for effective communication, teamwork, and problem solving skills
- Quality Assurance experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
- Has adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance
