DPEM Compliance specialist

Society for Conservation Biology; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading global healthcare company in Indianapolis seeks a DPEM Compliance Specialist to ensure quality systems for drug products. The role involves overseeing compliance, managing quality metrics, and fostering relationships with contract manufacturers. Ideal candidates will have a Bachelor's degree in Pharmacy or Chemistry and experience in GMP compliance.

Qualifications

• GMP compliance experience required.
• Technical and quality experience in manufacturing preferred.

Responsibilities

• Oversee DPEM and Contract Manufacturers quality systems.
• Ensure inspection readiness and manage quality metrics.
• Lead deviation and change control boards.

Skills

GMPs

Communication

Attention to Detail

Analytical Skills

Teamwork

Decision-Making

Problem-Solving

Cultural Diversity Appreciation

Education

Bachelor's Degree in Pharmacy

Bachelor's Degree in Chemistry

Job description

At Lilly, we unite caring with discovery to make life better for people around the world.

We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees worldwide work to discover and bring life-changing medicines to those in need, improve understanding and management of disease, and give back through philanthropy and volunteerism. We prioritize our work and put people first. We are seeking individuals committed to making a positive impact globally.

Drug Product External Manufacturing Quality Assurance

This department ensures the safety and efficacy of drug products for patients worldwide by overseeing contract manufacturers and alliance partners. Responsibilities include process step oversight from selection, validation, ongoing operations, to termination. We foster open communication and maintain effective relationships with our partners and internal teams.

Role: DPEM Compliance Specialist

The specialist will oversee DPEM and Contract Manufacturers (CMs) quality systems, including:

1. Ensuring inspection readiness at CMs, maintaining an inspection calendar, representing DPEM at PAI inspection readiness meetings, and sharing observations and trends.
2. Monitoring quality systems through quality plans and self-inspections.
3. Leading deviation and change control boards (CRB/DRB).
4. Analyzing deviations and change control trends.
5. Maintaining site-to-site quality agreements within Lilly.
6. Managing DPEM quality metrics and driving continuous improvement.
7. Participating actively in QLT and other relevant forums.

Qualifications

Education:

• Bachelor's Degree in Pharmacy, Chemistry, or equivalent experience.

Experience:

• GMP compliance experience.
• Technical and quality experience in manufacturing preferred.

Skills:

• Understanding of GMPs and Lilly Quality Standards.
• Strong communication, attention to detail, and analytical skills.
• Teamwork, organization, prioritization, and influencing abilities.
• Decision-making and problem-solving skills.
• Experience working in virtual and complex environments.
• Appreciation for cultural diversity.

Additional Information

Lilly is committed to inclusivity and equal opportunity. If accommodations are needed during the application process, please complete the workplace accommodation request form. We do not discriminate based on age, race, religion, gender, sexual orientation, gender identity, national origin, veteran status, disability, or other protected classes.

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