MSD
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 standards of quality 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. The Quality Compliance Director will drive FDA and global inspection readiness, oversee site internal audits and Health Authority reporting, design strategic corrective actions, and develop a high-performing compliance team. The role ensures site compliance with cGMP and applicable regulations and leads continuous improvement of compliance systems. Key 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, industry standards and 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 working with Regulatory with relevant submissions for new product launches Oversee Health Authority reporting (BPDRs, DPRs, FARs), market action events, and complaint assessment and reporting decisions. Works with responsible teams to author and submit the required health authority notification and any follow-up action. Partner cross-functionally (Operations, Regulatory, QC, R&D, Supply Chain) and with 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. US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please indicate accommodation needs during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement. We are proud to be a company that embraces diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. We encourage colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts. U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid model consisting of three total days on-site per week (Monday - Thursday), with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions located at a Company site, nor to roles designated as remote. Roles with collective-bargaining agreements may have different terms. The salary range for this role is $169,700.00 - $267,200.00. The actual offer will reflect factors such as education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at the compensation and benefits page of the company website. You can apply for this role through the company careers site. The application deadline is stated on this posting. San Francisco and Los Angeles Residents
San Francisco: We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles: We will consider all qualified applicants in a manner consistent with applicable laws including the City of Los Angeles Fair Chance Initiative for Hiring. Search Firm Representatives
Merck & Co., Inc. does not accept unsolicited assistance from search firms. CVs/resumes submitted by search firms without a valid written agreement will be the property of the company. No fees will be paid in such cases. Please, no phone calls or emails. Employee Status
Regular Relocation
Domestic VISA Sponsorship
No Travel Requirements
No Travel Required Flexible Work Arrangements
Not Applicable Shift
1st - Day Valid Driving License
No Hazardous Material(s)
N/A Job Posting End Date
11/5/2025 A job posting is effective until 11:59:59 PM on the day before the listed job posting end date. Please apply by the day before the end date.
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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 standards of quality 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. The Quality Compliance Director will drive FDA and global inspection readiness, oversee site internal audits and Health Authority reporting, design strategic corrective actions, and develop a high-performing compliance team. The role ensures site compliance with cGMP and applicable regulations and leads continuous improvement of compliance systems. Key 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, industry standards and 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 working with Regulatory with relevant submissions for new product launches Oversee Health Authority reporting (BPDRs, DPRs, FARs), market action events, and complaint assessment and reporting decisions. Works with responsible teams to author and submit the required health authority notification and any follow-up action. Partner cross-functionally (Operations, Regulatory, QC, R&D, Supply Chain) and with 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. US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please indicate accommodation needs during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. We comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement. We are proud to be a company that embraces diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. We encourage colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts. U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid model consisting of three total days on-site per week (Monday - Thursday), with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions located at a Company site, nor to roles designated as remote. Roles with collective-bargaining agreements may have different terms. The salary range for this role is $169,700.00 - $267,200.00. The actual offer will reflect factors such as education, qualifications, certifications, experience, skills, geographic location, government requirements, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and sick days. More information about benefits is available at the compensation and benefits page of the company website. You can apply for this role through the company careers site. The application deadline is stated on this posting. San Francisco and Los Angeles Residents
San Francisco: We will consider qualified applicants with arrest and conviction records in compliance with the San Francisco Fair Chance Ordinance. Los Angeles: We will consider all qualified applicants in a manner consistent with applicable laws including the City of Los Angeles Fair Chance Initiative for Hiring. Search Firm Representatives
Merck & Co., Inc. does not accept unsolicited assistance from search firms. CVs/resumes submitted by search firms without a valid written agreement will be the property of the company. No fees will be paid in such cases. Please, no phone calls or emails. Employee Status
Regular Relocation
Domestic VISA Sponsorship
No Travel Requirements
No Travel Required Flexible Work Arrangements
Not Applicable Shift
1st - Day Valid Driving License
No Hazardous Material(s)
N/A Job Posting End Date
11/5/2025 A job posting is effective until 11:59:59 PM on the day before the listed job posting end date. Please apply by the day before the end date.
#J-18808-Ljbffr