Merck
Overview
We are hiring a Quality Compliance Director to join the West Point Quality Assurance Leadership Team. The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our high quality standards and regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, and suppliers, our team creates a global manufacturing network dedicated to delivering a compliant, reliable supply to customers and Patients on time, every time, across the globe. Responsibilities
Lead FDA and Health Authority inspection readiness and responses; coordinate mock inspections, on-floor support, and regulatory communications. Build and maintain a Permanent Inspection Readiness (PIR) and internal audit program to detect gaps and monitor CAPA effectiveness. Track and interpret changes in regulations and industry standards; ensure proactive awareness and PIR at the site. Lead root-cause analysis and develop prioritized, measurable corrective and preventive actions; verify effectiveness with clear KPIs. Manage, coach, and grow a team of compliance professionals and internal auditors; set expectations and succession plans. Provide expertise in developing strategies for inspection readiness including coordination with Regulatory for relevant submissions for new product launches. Oversee Health Authority reporting (BPDRs, DPRs, FARs), market action events, and complaint assessment and reporting decisions. Work with responsible teams to author and submit the required health authority notification and any follow-up action. Partner cross-functionally with Operations, Regulatory, QC, R&D, Supply Chain and external suppliers to drive compliance. Drive simplification and continuous improvement of quality systems and supplier compliance monitoring. Qualifications
BA/BS and 10+ years leading quality audit/inspection strategies in large-molecule biologics or vaccines with strong FDA experience. Deep knowledge of cGMP, FDA inspection expectations, and relevant regulations (e.g., 21 CFR Part 11, Annex 11). Proven inspection management and PIR experience; experienced in authoring regulatory submissions and responses. Strong strategic thinking, analytical problem-solving, and CAPA management skills. Demonstrated people leadership in a matrix organization: hiring, coaching, performance management, and team development. Excellent communication, technical writing, project management, and stakeholder influence skills. Required Skills
Audit Inspections, Change Management, Coaching, FDA Inspections, FDA Regulations, Interpersonal Relationships, Leadership, Management Process, People Leadership, Quality Auditing, Quality Compliance, Regulatory Compliance, Risk Management, Strategic Thinking, Team Development Preferred Skills
Current Employees apply HERE; Current Contingent Workers apply HERE Other
U.S. And Puerto Rico Residents Only; Our company is committed to inclusion. If you need an accommodation during the application or hiring process, please click here. Requirements: As an Equal Employment Opportunity Employer, we provide equal opportunities and prohibit discrimination. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. See EEOC resources for Know Your Rights and GINA supplements. The job posting end date is 11/05/2025. This posting includes information about hybrid work, salary range, benefits, relocation, and travel requirements as applicable.
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We are hiring a Quality Compliance Director to join the West Point Quality Assurance Leadership Team. The West Point Quality organization ensures our products are manufactured, processed, tested, packaged, stored, and distributed aligned with our high quality standards and regulatory requirements. Partnering across our West Point campus, internal manufacturing facilities, and suppliers, our team creates a global manufacturing network dedicated to delivering a compliant, reliable supply to customers and Patients on time, every time, across the globe. Responsibilities
Lead FDA and Health Authority inspection readiness and responses; coordinate mock inspections, on-floor support, and regulatory communications. Build and maintain a Permanent Inspection Readiness (PIR) and internal audit program to detect gaps and monitor CAPA effectiveness. Track and interpret changes in regulations and industry standards; ensure proactive awareness and PIR at the site. Lead root-cause analysis and develop prioritized, measurable corrective and preventive actions; verify effectiveness with clear KPIs. Manage, coach, and grow a team of compliance professionals and internal auditors; set expectations and succession plans. Provide expertise in developing strategies for inspection readiness including coordination with Regulatory for relevant submissions for new product launches. Oversee Health Authority reporting (BPDRs, DPRs, FARs), market action events, and complaint assessment and reporting decisions. Work with responsible teams to author and submit the required health authority notification and any follow-up action. Partner cross-functionally with Operations, Regulatory, QC, R&D, Supply Chain and external suppliers to drive compliance. Drive simplification and continuous improvement of quality systems and supplier compliance monitoring. Qualifications
BA/BS and 10+ years leading quality audit/inspection strategies in large-molecule biologics or vaccines with strong FDA experience. Deep knowledge of cGMP, FDA inspection expectations, and relevant regulations (e.g., 21 CFR Part 11, Annex 11). Proven inspection management and PIR experience; experienced in authoring regulatory submissions and responses. Strong strategic thinking, analytical problem-solving, and CAPA management skills. Demonstrated people leadership in a matrix organization: hiring, coaching, performance management, and team development. Excellent communication, technical writing, project management, and stakeholder influence skills. Required Skills
Audit Inspections, Change Management, Coaching, FDA Inspections, FDA Regulations, Interpersonal Relationships, Leadership, Management Process, People Leadership, Quality Auditing, Quality Compliance, Regulatory Compliance, Risk Management, Strategic Thinking, Team Development Preferred Skills
Current Employees apply HERE; Current Contingent Workers apply HERE Other
U.S. And Puerto Rico Residents Only; Our company is committed to inclusion. If you need an accommodation during the application or hiring process, please click here. Requirements: As an Equal Employment Opportunity Employer, we provide equal opportunities and prohibit discrimination. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. See EEOC resources for Know Your Rights and GINA supplements. The job posting end date is 11/05/2025. This posting includes information about hybrid work, salary range, benefits, relocation, and travel requirements as applicable.
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