Director, Global Quality & Compliance Support

Quality & Compliance Director

We are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal and external contract manufacturing organizations (CMOs). This critical leadership role will collaborate with a network of professionals responsible for the manufacturing of active pharmaceutical ingredients (APIs) and finished products, including biologics and vaccines. As a trusted GMP compliance expert, you will drive regulatory excellence, support health authority inspections, and ensure robust corrective and preventative actions (CAPA) are effectively implemented to maintain the highest quality standards.

Key Responsibilities:

• GMP Compliance Leadership: Serve as the subject matter expert (SME) on current good manufacturing practices (CGMP) for pharmaceutical manufacturing, including large molecule manufacturing, guiding compliance for internal and external teams worldwide.
• Inspection Readiness & Support: Supports preparation efforts for regulatory audits and inspections, including a holistic lifecycle support for pre-approval inspection (PAI) for the company's growing pipeline of products and launches.
• CAPA Management: Collaborate with company and CMO teams to develop, monitor, and verify CAPA plans addressing global audit and inspection findings, ensuring timely and effective resolution.
• Regulatory Intelligence & Trend Analysis: Gather and analyze regulatory updates and inspection outcomes to identify trends, drive improvements, and report findings to senior quality and management councils.
• Regulatory Consultation: Offers proactive interpretation and consultation to project teams and sites on global pharmaceutical regulations, guidelines, compliance hot topics, policies, and procedures.
• Industry Engagement: Represent the company in key industry organizations such as PDA, PQRI, PhRMA, and ISPE to stay at the forefront of regulatory and quality best practices.

Qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or a related field.
• 10+ years of progressive experience in Quality Compliance, preferably within large molecule manufacturing (biologics and/or vaccines).
• Deep expertise in GMP requirements across multiple regulatory agencies (FDA, EU, ROW)
• Strong understanding of different pharmaceutical manufacturing processes, including Low Bioburden and sterile operations.
• Proven track record supporting health authority inspections and implementing effective CAPA.
• Ability to interpret and apply regulatory expectations to maintain a robust Quality Management System (QMS).

Core Competencies:

• Drive Results: Set clear goals, overcome challenges, and deliver measurable outcomes.
• Decisive Judgment: Make timely, data-driven decisions with confidence and discipline; demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions.
• Courage & Integrity: Advocate for compliance with transparency and escalate issues appropriately.
• Collaborative Leadership: Influence and align diverse teams to achieve consensus and shared objectives.

The salary range for this role is $169,700.00 - $267,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.