Quality Leader, Capital Projects & Regulatory Compliance

MSD; Upper Gwynedd Township (Montgomery County); Presencial; USD 129 000 - 203 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid holidays

Vacation and sick days

Resumo da oferta

Merck in the United States seeks an Associate Director, Quality Lead for a Drug Substance capital project. You will oversee quality systems, partner with operations, and ensure compliance with cGMPs and regulatory requirements across design, qualification, and approval phases.

You will interact with regulatory inspectors during pre-approval inspections, demonstrate strong analytical and leadership capabilities, and drive cross-functional collaboration to achieve site priorities.

Qualificações

• Bachelor’s degree with 8+ years in Operations, Quality, Technology or related field; or Master’s with 6+ years.
• Experience in CGMPs and regulatory standards (FDA/EMEA) and a strong compliance mindset.
• Experience managing direct reports (2+ years).
• Knowledge of quality systems, deviation handling, CAPA, change controls.

Responsabilidades

• Execute quality system functions relating to GMP compliance and lead multi-department teams.
• Ensure adherence to company policies and all applicable regulations.
• Ensure safety and environmental policy compliance across the team.
• Participate in governance committees, operations reviews, and regulatory forums.
• Acquire and maintain technical process knowledge to support decision making.
• Review and approve compliance documents (deviations, CAPA, change requests).
• Serve as primary Quality lead for Capital Project design, qualification and approvals.

Conhecimentos

People management

CGMP/FDA/EMEA knowledge

Analytical thinking

Cross-functional collaboration

Problem solving

Regulatory alignment

Formação académica

Bachelor’s Degree in Science/Engineering

Master’s Degree in Science/Engineering

Descrição da oferta de emprego

Merck in the United States seeks an Associate Director, Quality Lead for a Drug Substance capital project. You will oversee quality systems, partner with operations, and ensure compliance with cGMPs and regulatory requirements across design, qualification, and approval phases.

You will interact with regulatory inspectors during pre-approval inspections, demonstrate strong analytical and leadership capabilities, and drive cross-functional collaboration to achieve site priorities.