Senior Director, Quality Operations & Compliance

cosettepharma; Lincolnton (NC); On-site; USD 130,000 - 160,000; Full time

Job summary

Cosette Pharmaceuticals, Inc., based in Lincolnton, NC, is seeking a Senior Director, Quality Operations. This role involves leading the Quality organization, ensuring compliance with cGMP regulations, and overseeing regulatory inspections.

The ideal candidate will have a Bachelor’s Degree and over 15 years of experience in pharmaceutical quality management. You will be responsible for directing quality assurance activities and overseeing analytical and microbiology lab operations.

Qualifications

• 15+ years of pharmaceutical quality experience in a manufacturing or CMO environment.
• Strong understanding of compliance and regulatory requirements in pharmaceuticals.
• Experience with product development lifecycle including design and validation.

Responsibilities

• Lead the Quality organization and ensure compliance with cGMP.
• Oversee regulatory inspections and maintain quality assurance standards.
• Direct the analytical and microbiology laboratory functions.

Skills

cGMP compliance

Leadership

Analytical proficiency

Microbiological proficiency

Cross-functional teamwork

Education

Bachelor's Degree in life sciences, engineering, or business

Job description

Cosette Pharmaceuticals, Inc., based in Lincolnton, NC, is seeking a Senior Director, Quality Operations. This role involves leading the Quality organization, ensuring compliance with cGMP regulations, and overseeing regulatory inspections.

The ideal candidate will have a Bachelor’s Degree and over 15 years of experience in pharmaceutical quality management. You will be responsible for directing quality assurance activities and overseeing analytical and microbiology lab operations.