Senior Compliance Specialist

Senior Compliance Specialist (Supplier Quality / External Auditing)Onsite Michigan (Pharmaceutical Manufacturing Environment)Full-Time | PermanentWork with a rapidly growing, science-driven pharmaceutical manufacturing organization focused on delivering high-quality, compliant solutions within a GMP-regulated environment. This organization operates with a strong commitment to quality, operational excellence, and continuous improvement, supporting critical programs across the pharmaceutical and biotechnology landscape.We are seeking a Senior Compliance Specialist to take ownership of Supplier Quality Management and external audit activities, playing a key role in maintaining inspection readiness and strengthening quality systems. This is a highly visible position that partners cross-functionally with Quality, Manufacturing, Regulatory, and external stakeholders to ensure compliance with global regulatory expectations.Key Responsibilities Include:Supplier Quality & External Auditing:Lead and execute supplier audits, including on-site and remote assessments of GMP vendors, contract laboratories, and service providers Maintain oversight of supplier qualification and performance within the Quality Management System Establish and manage quality agreements with external partners Act as a primary Quality representative in external-facing audit activities Quality Systems Oversight & Compliance:Serve as process owner for Supplier Quality Management, ensuring alignment with internal procedures and regulatory requirements Maintain working knowledge of FDA regulations, cGMP standards, and industry best practices Support quality systems including internal audits, complaint handling, regulatory surveillance, and change control Ensure inspection readiness through proactive compliance monitoring and system improvements Performance Monitoring & Continuous Improvement:Track and trend supplier quality metrics, identifying risks and areas for improvement Lead or support deviations, investigations, CAPAs, and effectiveness checks Collaborate cross-functionally to implement corrective and preventive actions Contribute to continuous improvement initiatives across quality systems Cross-Functional Collaboration:Partner with Manufacturing, Quality Control, Regulatory Affairs, and Engineering teams Provide clear communication to stakeholders regarding compliance risks and audit outcomes Support quality-driven decision-making through data analysis and reporting Travel Requirement:Approximately 40% travel required Includes routine on-site supplier audits and external partner visits (domestic and occasional international) Candidates must be comfortable with frequent travel and representing Quality in external environments Qualifications:Bachelor’s degree in Life Sciences, Chemistry, Biology, or related field (required) 5-10+ years of experience within Quality Assurance / Quality Control in a GMP-regulated pharmaceutical, biotech, or related manufacturing environment Strong experience with supplier quality management and auditing In-depth knowledge of FDA regulations, 21 CFR 210/211, and cGMP requirements Experience working with electronic Quality Management Systems (eQMS) Strong technical writing, documentation, and investigation skills Ability to manage multiple priorities in a fast-paced environment Preferred:Experience within a contract manufacturing (CDMO/CMO) or high-growth environment Exposure to aseptic or sterile manufacturing processes Experience with process ownership or project-based quality initiatives What’s Offered:Competitive compensation aligned to experience Annual performance-based incentives Comprehensive benefits package including: Medical, dental, and vision insurance Paid time off and company holidays Retirement plan with employer contribution Life insurance and disability coverage Opportunity to join a high-growth organization with strong investment in Quality and Compliance Important:This role is fully onsite 40% travel is required Visa sponsorship is not available