Senior Director, Global Quality & Third-Party Excellence

Merck & Co.; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Job summary

HireLifeScience seeks a Senior Director, Biologics, DP, & Device Platform Lead, TPQM & DD, Global Development Quality, to provide strategic, scientific and operational leadership to teams.

This position leads initiatives, builds talent, and oversees third-party contractors and vendors supporting biologic drug substance, sterile and non-sterile drug product, and medical devices across the clinical supply chain.

Qualifications

• Bachelor's degree in engineering, biology, chemistry or related field.
• 10+ years pharma industry experience or 8+ years with advanced degree.
• Experience with regulatory officials and external audits.

Responsibilities

• Lead TPQM & DD strategy and global quality vision across a vendor base.
• Oversee quality performance and compliance robustness for biologics, devices and CP.
• Manage a team of about 9 Quality professionals and mentor staff.
• Collaborate with senior management on regulatory matters and audits.
• Drive continuous improvement of third-party quality processes.
• Coordinate with Global Auditing and cross-functional partners on issues.

Skills

R&D expertise

Regulatory compliance

Drug development

Continuous improvement

Leadership

Quality risk management

Cross-functional teamwork

Communication

People management

Stakeholder management

Education

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

Advanced Degree with 8+ years relevant experience

Job description

HireLifeScience seeks a Senior Director, Biologics, DP, & Device Platform Lead, TPQM & DD, Global Development Quality, to provide strategic, scientific and operational leadership to teams.

This position leads initiatives, builds talent, and oversees third-party contractors and vendors supporting biologic drug substance, sterile and non-sterile drug product, and medical devices across the clinical supply chain.