Associate Director, Global Product Quality & Compliance

Merck; Rahway (NJ); Ibrido; USD 142.000 - 224.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Long-term incentive

Descrizione del lavoro

Merck in Rahway, NJ seeks an Associate Director to guide global product quality complaint management for MDCP. You will lead investigations, escalations, and regulatory reporting, collaborating with Global Safety, manufacturing sites, and external partners to ensure timely, compliant resolutions.

The role emphasizes cross-functional leadership, policy development, and process improvements, including use of new technologies for data signaling and continuous quality improvement in a complex,

Competenze

• Bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR a Master’s degree (Science or Engineering or associated fields) and 5 years related experience or a Ph.D. (Science or Engineering or associated fields) and 3 years of related experience
• 7 years relevant experience including Regulatory CMC, Quality, development, manufacturing, testing or licensure of pharmaceutical products; or related fields.
• LEADERSHIP: Requires established ability to manage and implement multiple projects/tasks simultaneously with competing priorities; ... strong demonstrated interpersonal, communication, collaboration and leadership skills; and ability to work in a multi-cultural environment.

Mansioni

• Provide guidance to assure compliance of MDCP complaint management with regulatory expectations.
• Serve as SME for complaint management and lead investigations, health authority reporting and global PQC activities.
• Support regulatory inspections and align processes with QMS.
• Lead cross-functional teams to develop and improve business processes and databases for PQCs/AE quality issues.

Conoscenze

Regulatory CMC

Quality assurance

Leadership

Cross-functional collaboration

Technical writing

Risk management

Formazione

Bachelor’s degree in Science or Engineering

Master’s degree in Science or Engineering

Ph.D. in Science or Engineering

Descrizione del lavoro

Merck in Rahway, NJ seeks an Associate Director to guide global product quality complaint management for MDCP. You will lead investigations, escalations, and regulatory reporting, collaborating with Global Safety, manufacturing sites, and external partners to ensure timely, compliant resolutions.

The role emphasizes cross-functional leadership, policy development, and process improvements, including use of new technologies for data signaling and continuous quality improvement in a complex,