Associate Director, API Supplier Quality Management
Eli Lilly and Company
full-time
Posted on:
Location Type: Hybrid
Location: Philadelphia • Pennsylvania • United States
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Salary
💰 $115,500 - $169,400 per year
Job Level
About the role
- Leads the qualification and quality oversight of contract manufacturers and associated suppliers and service providers
- Designs and enhances the risk-based precursor program and leads efforts to update established procedures in alignment with Lilly corporate quality standards
- Completes sponsor release and manages quality distribution activities for precursor and reference standard
- Reviews and approves the validation and testing method transfers for precursor and reference standard methods ensuring compliance with ICH and Lilly quality standards
- Collaborates with cross functional team members and external contract manufacturing partners to investigate and resolve manufacturing issues
- Develops, executes and maintains supplier quality agreements
- Coordinates audit scheduling with the global compliance team and serves as an audit team member or facilitator, as required
- Authors precursor section of annual product review and periodic quality management review
- Partners with supplier quality management to support supplier periodic reviews and change notification assessments
- Educates and mentors team members on quality requirements and expectations
Requirements
- Bachelor’s degree - Preferred in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry
- Minimum 5 years’ experience in pharmaceutical manufacturing or Quality Assurance. Preferred strong chemistry background in API production.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
- Strong knowledge of commercial and investigational drug product quality management
- Thorough knowledge of applicable regulations, such as global GMP regulations: US, EU, Japan, ICH Q7 along with IPEC, and ISO standards and the ability to interpret and apply them
- Experience with API manufacturing validation and analytical method validation
- Familiarity with writing and revising Quality Agreements
- Proficient in root causes analysis, review and approval of deviations/investigations, quality assessment of CAPA Plans and change controls
- Ability to simplify complex processes/problems and propose alternate solutions
- Quality oversight experience with third party/contract manufacturing
- Demonstrated negotiation and influence skills
- Knowledge of radiopharmaceutical manufacturing GMP’s
- Able to communicate effectively in both written and verbal forms to both internal and external customers.
Benefits
- eligibility to participate in a company-sponsored 401(k)
- pension
- vacation benefits
- eligibility for medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
pharmaceutical manufacturingQuality AssuranceAPI productioncommercial drug product quality managementGMP regulationsICH Q7IPEC standardsISO standardsanalytical method validationroot cause analysis
Soft Skills
negotiation skillsinfluence skillscommunication skillsmentoringproblem-solving