DPEM Compliance specialist

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare company in Indianapolis is seeking a DPEM Compliance Specialist to oversee quality systems for contract manufacturers. The role requires a Bachelor's degree in Pharmacy or Chemistry and compliance experience within GMP functions. The ideal candidate will possess strong analytical and communication skills, and the ability to work effectively in a cross-functional team.

Qualifications

• Compliance experience within a GMP function.
• Experience in technical and quality functions within a manufacturing plant.

Responsibilities

• Ensure inspection readiness at contract manufacturers.
• Monitor quality systems through quality plans and self-inspections.
• Lead deviation and change control boards.

Skills

GMPs

Analytical skills

Communication

Interpersonal skills

Problem-solving

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 around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Drug Product External Manufacturing Quality Assurance assures patients worldwide of safe and efficacious drug products, through effective quality oversight contract manufacturers and alliance partners. This oversight covers the process steps of selection, pre-validation/validation, ongoing operations, and termination.

Drug Product External Manufacturing Quality Assurance is committed to creating partnerships that facilitate open communication and maintaining effective relationships with our alliance partners, contract manufacturers, and internal business customers.

The DPEM Compliance specialist will be responsible for the oversight of DPEM and Contract manufacturers (CMs) quality systems, including:

• Ensure inspection readiness at CMs, developing and maintaining an inspection calendar, representing DPEM at the PAI inspection readiness meetings and ensuring observations trends and experience sharing within DPEM and with Lilly sites
• Monitor DPEM and CMs quality system through quality plans monitoring and a Self-Inspection program
• Lead the Deviation and Change Control boards (CRB/DRB)
• Perform deviations and change control trends for DPEM and CMs
• Maintain site to site quality agreements (between DPEM and Lilly sites/ functions)
• Own the DPEM quality metrics process and ensure continuous improvement
• Be an active participant to the QLT and other applicable forums.

Education:

• Bachelor`s Degree in Pharmacy, Chemistry, or equivalent experience

Experience:

• Compliance experience within a GMP function.
• Experience in technical and quality functions within a manufacturing plant would be highly considered.

Skills:

• Technical understanding of GMPs and Lilly Global Quality Standards.
• Strong written and communication skills, especially attention to detail.
• Analytical skills and continuous improvement mindset.
• Interpersonal and teamwork skills, able to work effectively in a cross functional team environment.
• Ability to organize, prioritize, multi-task and influence others.
• Strong decision making and problem-solving skills.
• Capability to work in a virtual and complex environment.
• Appreciation for cultural diversity.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lillydoes not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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