Senior QA Leader API External Manufacturing

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Bonus potential

Comprehensive benefits

401(k)

Job summary

Lilly is seeking an API EM Quality Assurance Consultant to support quality activities at contract manufacturing organizations. This role ensures batches meet specifications and comply with cGMPs and regulatory commitments.

As a QA liaison, you will coordinate with CMs, manage quality issues, and participate in inspections, quality agreements, deviations, and change controls. Travel up to 20% may be required; authorized US work status is needed.

Qualifications

• Bachelor's degree in a science-related field.
• At least 2 years GMP manufacturing experience in API/pharma.
• Authorized to work in the United States on a full-time basis.

Responsibilities

• Serve as liaison between CMs and Lilly.
• Provide quality oversight of CM activities and be initial contact for quality issues.
• Escalate quality issues to Lilly QA management.
• Assist in establishment and revisions of Quality Agreements with affiliates and customers.
• Ensure compliance to Quality Agreements and MRDs.
• Coordinate QA responsibilities of API shipments from suppliers and CMs.
• Participate in regulatory inspection preparations with CMs and provide on-site support.
• Participate on the Technical Review Board (TRB).
• Evaluate and disposition API batches and ensure batch documentation.
• Maintain state of control and document deviations, changes, and countermeasures.

Skills

Quality systems knowledge

Regulatory requirements

Root cause analysis

Statistical skills

Written and verbal communication

Attention to detail

Interpersonal skills

Organizational skills

Relationship management

Education

Bachelor's degree in science (Pharmacy, Chemistry, Biological sciences)

Job description

Lilly is seeking an API EM Quality Assurance Consultant to support quality activities at contract manufacturing organizations. This role ensures batches meet specifications and comply with cGMPs and regulatory commitments.

As a QA liaison, you will coordinate with CMs, manage quality issues, and participate in inspections, quality agreements, deviations, and change controls. Travel up to 20% may be required; authorized US work status is needed.