Senior QA, External Manufacturing Oversight

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

Benefits offered by this job

Company bonus

Comprehensive benefits including medical and retirement plans

Flexible benefits options

Job summary

Initial Therapeutics, Inc. in Lebanon, IN is seeking a Quality Assurance External Manufacturing Representative to ensure quality oversight of contract manufacturers and alliance partners, focusing on compliance with regulatory requirements. The role demands strong leadership and teamwork skills, as well as a Bachelor's degree and over 3 years of relevant experience.

The successful candidate will maintain communication with contract manufacturers, manage quality-related issues, and support regulatory inspections. The anticipated wage for this role is $65,250 - $169,400 annually.

Qualifications

• 3+ years in the pharmaceutical manufacturing industry in Quality Assurance roles.
• Experience providing Quality Assurance oversight of contract manufacturers.
• Authorized to work in the United States.

Responsibilities

• Liaison between contract manufacturers and Lilly for quality oversight.
• Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents.
• Review and approve manufacturing documentation.

Skills

Quality Assurance oversight of contract manufacturers

Regulatory knowledge

Problem-solving skills

Technical writing

Communication skills

Education

Bachelor's degree in a relevant field

Tools

Manufacturing Execution Systems

Job description

Initial Therapeutics, Inc. in Lebanon, IN is seeking a Quality Assurance External Manufacturing Representative to ensure quality oversight of contract manufacturers and alliance partners, focusing on compliance with regulatory requirements. The role demands strong leadership and teamwork skills, as well as a Bachelor's degree and over 3 years of relevant experience.

The successful candidate will maintain communication with contract manufacturers, manage quality-related issues, and support regulatory inspections. The anticipated wage for this role is $65,250 - $169,400 annually.