Senior Director, Biologics Quality & Vendor Oversight

Regulatory Jobs; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Job summary

Merck seeks a Senior Director of Biologics, DP, & Device Platform Lead to provide strategic, scientific, and operational leadership to TPQM & DD teams. This role oversees third‑party quality management for biologics, device and combination products across a global vendor base, with a focus on quality strategy and risk mitigation.

The position leads a team of over 9 professionals and collaborates with senior management across functions, audits, and regulatory bodies to ensure compliance and

Qualifications

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

Responsibilities

• Execute the daily operational TPQM support for the biologics drug substance and sterile and non-sterile drug product vendor bases related to the most complex activities that our company outsources, with the associated potential for high impact to the development portfolio.
• Supporting the development of and driving the execution of quality strategies, improvement initiatives in line with business drivers and objectives.
• Provide close support to our company’s Global Auditing group in relation to audits conducted and mitigation activities in regard to audit observations for the designated vendor base.
• Interacting cross-functionally and cross-divisionally with senior management on quality/regulatory matters as well as special projects, and externally with inspectors and colleagues in industry in relation to the designated vendor base.
• Driving the resolution of contractor / vendor related business practice, Quality and/ or compliance issues of high-impact scope and highest level of complexity on cross-functional and/ or cross-divisional basis in relation to the designated vendor base.

Education

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

Job description

Merck seeks a Senior Director of Biologics, DP, & Device Platform Lead to provide strategic, scientific, and operational leadership to TPQM & DD teams. This role oversees third‑party quality management for biologics, device and combination products across a global vendor base, with a focus on quality strategy and risk mitigation.

The position leads a team of over 9 professionals and collaborates with senior management across functions, audits, and regulatory bodies to ensure compliance and