Senior Director, Third-Party Quality & Biologics Ops

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

Vantaggi offerti da questo lavoro

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays & vacation

Descrizione del lavoro

Merck in the United States is seeking a Senior Director, Biologics, DP, & Device Platform Lead for TPQM & DD to provide strategic and operational leadership over third-party quality management across biologics and devices, ensuring regulatory compliance and risk mitigation in the clinical supply chain.

You will lead a team of 9+ professionals, collaborate with vendors and stakeholders, drive continuous improvement, and navigate complex quality challenges; hybrid work with travel up to 25%.

Competenze

• Bachelor's degree in engineering, Biology, Chemistry, or related field.
• A minimum of 10+ years of relevant pharmaceutical industry experience, or 8+ years with advanced degree.
• Experience interacting with regulatory officials and external auditing parties.

Mansioni

• Execute daily operational TPQM support for biologics drug substances and sterile/non-sterile products.
• Develop and drive quality strategies and improvement initiatives.
• Support Global Auditing group with audits and mitigation of observations.
• Collaborate with senior management on quality/regulatory matters and cross-functional projects.
• Coach and develop team members in quality leadership.

Conoscenze

Coaching

Compliance Reporting

Detail-Oriented

External Manufacturing

Leadership Theories

People Leadership

Quality Management

Strategic Objectives

Formazione

Bachelor's degree in engineering, Biology, Chemistry, or related field

10+ years of pharmaceutical industry experience

Experience with regulatory officials & external auditing

Descrizione del lavoro

Merck in the United States is seeking a Senior Director, Biologics, DP, & Device Platform Lead for TPQM & DD to provide strategic and operational leadership over third-party quality management across biologics and devices, ensuring regulatory compliance and risk mitigation in the clinical supply chain.

You will lead a team of 9+ professionals, collaborate with vendors and stakeholders, drive continuous improvement, and navigate complex quality challenges; hybrid work with travel up to 25%.