Quality Operations Manager, GMP & CMC (Pharma)

Convergent Therapeutics, Inc.; Boston (MA); On-site; USD 122,000 - 150,000; Full time

Job summary

A clinical-stage radiopharmaceutical company is looking for a Manager of Quality Operations to oversee quality assurance systems and support the CMC activities. The role requires at least 5 years of quality assurance experience in the pharmaceutical industry and expertise in GMP regulations. The candidate should have excellent communication and interpersonal skills, a strong track record in managing quality systems, and the ability to work in a fast-paced environment. This mid-senior level position offers a full-time role with travel of up to 15%.

Qualifications

• 5+ years of experience in quality assurance within the pharmaceutical industry.
• Experience in new therapeutic modality manufacturing and clinical trial supplies.
• Proven track record managing GMP-compliant quality systems.

Responsibilities

• Oversee the development of batch records, validation protocols.
• Interact with manufacturing and operations to ensure quality.
• Support vendor qualification and monitor vendor performance.

Skills

GMP regulations

Interpersonal skills

Problem-solving

Communication skills

Critical thinking

Education

Advanced degree in chemistry, biochemistry, radiochemistry, or related field

Job description

A clinical-stage radiopharmaceutical company is looking for a Manager of Quality Operations to oversee quality assurance systems and support the CMC activities. The role requires at least 5 years of quality assurance experience in the pharmaceutical industry and expertise in GMP regulations. The candidate should have excellent communication and interpersonal skills, a strong track record in managing quality systems, and the ability to work in a fast-paced environment. This mid-senior level position offers a full-time role with travel of up to 15%.