Senior Director, Product Quality & CMC Leader

BioSpace; Kansas; Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading biotechnology company is seeking a Product Quality Leader to oversee quality for products from clinical development through commercialization. The role involves influencing global strategies, managing product quality risks, and collaborating across teams to ensure robust quality practices. The ideal candidate has over 12 years of experience in the biotech or pharmaceutical sectors and possesses strong leadership and interpersonal skills. This position is located in Kansas, United States, with some travel expected.

Qualifications

• 12+ years in Biotechnology, Pharmaceutical, or Medical Device industry.
• Experience in both clinical and commercial phases.
• Skilled in working with ambiguity and complexity.

Responsibilities

• Serve as the technical quality expert for products during development.
• Lead the Quality Partner Team supporting CMC deliverables.
• Manage product quality risk register and ensure issue resolution.

Skills

Interpersonal skills

Leadership capability

Decision-making

Quality management

Regulatory knowledge

Education

BA/BS in life sciences

Advanced degree (desirable)

Job description

A leading biotechnology company is seeking a Product Quality Leader to oversee quality for products from clinical development through commercialization. The role involves influencing global strategies, managing product quality risks, and collaborating across teams to ensure robust quality practices. The ideal candidate has over 12 years of experience in the biotech or pharmaceutical sectors and possesses strong leadership and interpersonal skills. This position is located in Kansas, United States, with some travel expected.