Quality Leader, Capital Projects | GMP & Regulatory

Merck & Co.; West Point (PA); Presencial; USD 129.000 - 203.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Descripción de la vacante

Merck & Co. in West Point, PA is seeking an Associate Director, Quality to provide quality direction for a Drug Substance capital project, ensuring compliance with CGMPs and regulatory requirements across training, documentation, change control, inspection management, and the QMS.

This role partners with operations to ensure the facility is designed and qualified to meet regulatory standards. The position requires strong leadership, regulatory interaction experience, and the ability to manage

Formación

• Minimum two concurrent years' experience managing direct reports.
• Strong understanding of CGMPs, FDA and EMEA regulatory standards and strong compliance mindset.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

Responsabilidades

• Executing quality system functions relating to GMP compliance and leading multi-department teams.
• Ensuring personnel follow policies and CGMPs and applicable regulations.
• Ensuring safety and environmental policy compliance.
• Serving on governance committees and regulatory forums and driving strategic initiatives.
• Acquiring and maintaining technical process knowledge to support decision making.
• Reviewing and approving deviations, CAPAs, commitments, and change requests.
• Primary Quality lead for Capital Project support in design, qualification and approval phase.

Conocimientos

Direct report management

CGMP knowledge

Regulatory compliance

Educación

Bachelor's or higher in science/engineering (8+ yrs experience)

Master's in science/engineering (6+ yrs)

Descripción del empleo

Merck & Co. in West Point, PA is seeking an Associate Director, Quality to provide quality direction for a Drug Substance capital project, ensuring compliance with CGMPs and regulatory requirements across training, documentation, change control, inspection management, and the QMS.

This role partners with operations to ensure the facility is designed and qualified to meet regulatory standards. The position requires strong leadership, regulatory interaction experience, and the ability to manage