Senior Director, Quality Operations & Compliance

Cosette Pharmaceuticals, Inc.; Lincolnton (NC); On-site; USD 180,000 - 240,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. is seeking a Senior Director, Quality Operations to lead quality initiatives and ensure cGMP compliance at the North Carolina manufacturing facility.

You will oversee Quality Assurance, Quality Systems, Quality Affairs and Quality Control, directing regulatory inspections and maintaining external relationships with regulators and key opinion leaders. Responsibilities include setting goals for QA, guiding deviation handling, document review, and overseeing analytical

Qualifications

• A Bachelor's Degree or higher degree in life sciences, engineering, or business.
• 15+ years pharmaceutical quality experience in manufacturing, CMO, or life sciences tech.
• Analytical and Microbiological proficiency related to semi-solids drug products.
• Extensive experience in cGMP and regulatory compliance.
• Proven leadership and ability to drive strategic growth in quality.

Responsibilities

• Provides leadership and direction to the Quality organization.
• Mentors and develops QA, Quality System, Quality Affairs, and QC staff.
• Leads key quality strategic and operational decisions with company impact.
• Oversees regulatory inspections with FDA or other agencies.
• Directs development of systems and processes for change controls and reviews.
• Oversees analytical and microbiology labs: release/testing, stability, EM.

Skills

Leadership

Cross-functional teamwork

Analytical proficiency

Regulatory compliance

Quality management

Education

Bachelor’s degree or higher in life sciences/engineering/business

Job description

Cosette Pharmaceuticals, Inc. is seeking a Senior Director, Quality Operations to lead quality initiatives and ensure cGMP compliance at the North Carolina manufacturing facility.

You will oversee Quality Assurance, Quality Systems, Quality Affairs and Quality Control, directing regulatory inspections and maintaining external relationships with regulators and key opinion leaders. Responsibilities include setting goals for QA, guiding deviation handling, document review, and overseeing analytical