Experienced FDA Compliance Consultant Needed

Job Summary: We are seeking an experienced FDA Compliance Consultant to conduct comprehensive mock FDA audits/inspections for our organization. The consultant will evaluate our quality systems, identify compliance gaps, and prepare our team for actual FDA inspections. This role is critical in ensuring our company maintains the highest standards of regulatory compliance in the pharmaceutical, medical device, or biologics industry. Responsibilities • Conduct thorough mock FDA audits/inspections simulating actual FDA procedures • Evaluate quality systems, documentation, manufacturing processes, and training programs • Identify compliance gaps and propose practical corrective and preventive actions (CAPAs) • Perform risk assessments and develop mitigation plans • Train staff on FDA compliance requirements and inspection readiness • Conduct post-audit debriefings and provide actionable recommendations • Coordinate comprehensive mock audit schedules and manage multiple stakeholders • Maintain strict confidentiality of sensitive company information Qualifications: • Bachelor's degree in life sciences, biology, chemistry, pharmacy, or engineering • 5-10 years of experience in regulatory compliance within FDA-regulated industries • Hands-on experience conducting or participating in FDA audits/inspections • In-depth understanding of FDA guidelines, regulations, and inspection processes (GMP, GLP, GCP) • Familiarity with industry standards (ISO 13485, ISO 9001, ICH guidelines) • Proficiency in identifying compliance gaps and proposing CAPAs • Strong verbal and written communication skills • Exceptional organizational and time-management abilities Preferred Qualifications: • Advanced degree (MBA, MS, or PhD) in a relevant field • Certified auditor credentials (e.g., Certified Quality Auditor) • Experience in the specific industry of the company (e.g., Nano particles, calcium phosphate, spinal medical devices) Competencies: • Regulatory expertise • Attention to detail • Critical thinking and problem-solving • Effective communication and training skills • Project management • Ethical conduct and confidentiality • Adaptability to different organizational contexts