Product Quality Lead — Pharma & Regulatory Impact

BioSpace; Indianapolis (IN); Sur place; USD 66 000 - 169 000; Plein temps

Avantages offerts par ce poste

401(k) eligibility

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Prescription drug benefits

Flexible benefits

Life insurance

Death benefits

Time off and leave

Well-being benefits

Résumé du poste

Lilly is seeking a Product Quality Lead to oversee quality activities for assigned programs in the U.S. You will investigate product complaints, support temperature excursion evaluations, and coordinate with Manufacturing, Regulatory, and Supply Chain teams to ensure compliant releases.

Qualifications include a BS/MS in Life Sciences and 5–10 years of pharma quality experience, with knowledge of GMP systems. Compensation ranges from $66,000 to $169,400 annually, with a company bonus opportunity.

Qualifications

• BS/MS in Life Sciences.
• 5–10 years pharmaceutical quality experience.
• Knowledge of GMP manufacturing and quality systems.

Responsabilités

• Serve as Product Quality Lead for assigned program(s).
• Investigate and finalize reporting activities for potential product complaints.
• Support Clinical Operations as required in the evaluation of product temperature excursions.
• Support manufacturing campaigns and release activities.
• Ensure archival for expedient retrieval of key manufacturing documentation.
• Review deviations, investigations, CAPAs, and change controls for adequacy.
• Analyze and report on product quality trends.
• Facilitate risk assessments and mitigation activities and perform routine risk monitoring.
• Partner with Technical Operations, Supply Chain, Regulatory Affairs, and Manufacturing teams to support regulatory submissions.
• Support inspections and audits.

Connaissances

Quality systems

GMP knowledge

Pharmaceutical quality experience

Formation

BS/MS in Life Sciences

Description du poste

Lilly is seeking a Product Quality Lead to oversee quality activities for assigned programs in the U.S. You will investigate product complaints, support temperature excursion evaluations, and coordinate with Manufacturing, Regulatory, and Supply Chain teams to ensure compliant releases.

Qualifications include a BS/MS in Life Sciences and 5–10 years of pharma quality experience, with knowledge of GMP systems. Compensation ranges from $66,000 to $169,400 annually, with a company bonus opportunity.