Sr. Compliance Specialist

Standard Monday–Friday schedule.

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and safety standards.
• Cleanroom restrictions: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• Office environment with some degree of PPE required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).

Responsibilities

• Audit Management
  • Lead the planning, coordination, and execution of health authority inspections (e.g., FDA, EMA, MHRA) and client audits.
  • Serve as the primary point of contact during audits, ensuring timely and accurate communication with auditors.
  • Prepare audit-ready documentation and ensure site/functional readiness through routine assessments and mock audits.
• Audit Response & Remediation
  • Oversee the review, classification, and response to audit observations, ensuring clarity, accuracy, and regulatory alignment.
  • Partner with cross-functional teams to develop comprehensive responses that address root causes.
  • Ensure timely submission of audit responses and commitments to regulatory authorities and clients.
• CAPA Management & Effectiveness
  • Lead CAPA development, ensuring root cause analyses are thorough and scientifically sound.
  • Review and approve CAPA plans for adequacy, feasibility, and compliance risk mitigation.
  • Monitor CAPA implementation and verify effectiveness through appropriate metrics, trending, and follow-up activities.
  • Drive continuous improvement of CAPA processes to enhance compliance and operational performance.
• Regulatory Compliance Oversight
  • Ensure ongoing compliance with applicable regulations (e.g., GMP, GLP, GCP as applicable) and internal quality systems.
  • Interpret regulatory requirements and translate them into actionable procedures and controls.
  • Support regulatory inspections and internal audits by providing subject matter expertise.
• Cross-Functional Collaboration
  • Collaborate with Quality, Operations, Regulatory Affairs, and other stakeholders to ensure alignment on compliance strategies.
  • Provide guidance and training to teams on audit readiness, inspection conduct, and CAPA best practices.
• Metrics & Reporting
  • Track, trend, and report audit findings, CAPA status, and compliance metrics to senior management.
  • Identify systemic issues and drive proactive improvements to reduce compliance risk.

Requirements

• Advanced Degree plus 6 years of experience, or Bachelor’s Degree plus 8 years of experience in compliance, quality systems, or regulatory affairs.
• Professional certifications in Quality Systems, Regulatory Compliance, or related fields.
• Expertise in quality management systems and regulatory standards (ISO, GMP, FDA).
• Experience with compliance management software (Veeva, MasterControl, TrackWise).
• Proven ability to develop and implement standard operating procedures (SOPs).
• Strong project management and risk assessment capabilities.
• Effective stakeholder management and cross-functional collaboration skills.
• Advanced problem-solving and analytical skills.
• Strong written and verbal communication abilities.
• Demonstrated ability to lead internal/external audits.
• Proficiency in Microsoft Office Suite and relevant compliance tools.
• Strong attention to detail and ability to maintain accurate records.
• Ability to work independently while contributing to team objectives.
• Travel may be required.