Senior QA Lead, API External Manufacturing (Peptides)

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,250 - 169,400; Full time

Benefits offered by this job

Comprehensive benefits program

401(k) participation

Company bonus eligibility

Job summary

Initial Therapeutics, Inc. is looking for a skilled Quality Assurance professional to oversee API External Manufacturing operations. This role is critical for maintaining compliance with cGMP regulations and ensuring high-quality standards across third-party manufacturing partners.

Applicants should have a Bachelor's degree in a scientific discipline and at least 5 years of Quality Assurance experience in the pharmaceutical industry. The position is based in Indianapolis, Indiana and offers a competitive compensation package including potential bonuses and comprehensive benefits.

Qualifications

• Minimum 5 years experience in Quality Assurance in pharmaceutical or biopharmaceutical industry.
• Experience in auditing external manufacturing sites.
• Strong understanding of API manufacturing processes.

Responsibilities

• Lead and manage quality aspects of external API manufacturing sites.
• Conduct quality audits of external manufacturing sites.
• Review and approve quality-related documents.

Skills

Quality Assurance

cGMP regulations

Problem solving

Analytical skills

Quality management systems (e.g., Veeva)

Education

Bachelor's degree in Chemistry, Biochemistry, Pharmacy, or Chemical Engineering

Job description

Initial Therapeutics, Inc. is looking for a skilled Quality Assurance professional to oversee API External Manufacturing operations. This role is critical for maintaining compliance with cGMP regulations and ensuring high-quality standards across third-party manufacturing partners.

Applicants should have a Bachelor's degree in a scientific discipline and at least 5 years of Quality Assurance experience in the pharmaceutical industry. The position is based in Indianapolis, Indiana and offers a competitive compensation package including potential bonuses and comprehensive benefits.