Director, GMP Digital & Data Quality

Merck & Co.; West Point (PA); Ibrido; USD 173.000 - 273.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work arrangements

Annual bonus and long-term incentive

Comprehensive benefits package

Descrizione del lavoro

Merck & Co. is seeking a Director of Digital and Data Quality to lead the DDQ organization and oversee quality for GMP computerized systems across Company Manufacturing Division.

The role ensures compliance with policies and regulatory expectations, including systems impacting product quality and data integrity. You will collaborate with Quality Operations, Business Units, External Manufacturing, and IT, guiding a team in a highly regulated environment and driving continuous improvement in data

Competenze

• Strong knowledge of FDA/ICH/GAMP requirements and data integrity.
• Extensive experience validating GMP computerized systems and related quality processes.
• Proven ability to lead quality governance for regulated pharma systems.

Mansioni

• Support regulatory inspections and audits.
• Effectively manage DDQ resources and budgeting.
• Participate in hiring, training, and development of DDQ staff.
• Coach and develop direct reports to meet quality objectives.
• Align DDQ goals with regulatory expectations and corporate quality strategy.

Conoscenze

Regulatory knowledge

System validation

Quality systems

Formazione

Bachelor's degree in Science/IT/Engineering

Master's degree in Science/IT/Engineering/Business

Ph.D. in Science/IT/Engineering/Business

Descrizione del lavoro

Merck & Co. is seeking a Director of Digital and Data Quality to lead the DDQ organization and oversee quality for GMP computerized systems across Company Manufacturing Division.

The role ensures compliance with policies and regulatory expectations, including systems impacting product quality and data integrity. You will collaborate with Quality Operations, Business Units, External Manufacturing, and IT, guiding a team in a highly regulated environment and driving continuous improvement in data