Quality Assurance Compliance DPEM - Supplier Quality Management

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 63,000 - 163,000; Full time

Job summary

A leading healthcare company in Indianapolis is seeking a Quality Assurance professional to oversee drug product external manufacturing. The role involves ensuring compliance with quality standards, managing supplier relationships, and conducting audits. Ideal candidates will have a background in pharmacy or chemistry, along with experience in manufacturing quality assurance. This position offers a competitive salary and benefits, contributing to life-changing medicines.

Benefits

401(k) plan

Pension

Vacation benefits

Medical benefits

Dental benefits

Vision benefits

Flexible spending accounts

Life insurance

Employee assistance program

Fitness benefits

Qualifications

• 3+ years of experience in technical and quality functions within a manufacturing plant.
• Experience with parenteral products and dry products.

Responsibilities

• Oversee supplier complaint investigations and coordinate with contract manufacturers.
• Participate in CM performance reviews and maintain Product Specifications.
• Provide input to monthly reports to senior management.

Skills

Technical understanding of GMPs

Strong written and communication skills

Interpersonal and teamwork skills

Strong decision making and problem-solving skills

Education

Bachelor`s Degree in Pharmacy

Bachelor`s Degree in Chemistry

Tools

SAP

Trackwise

QDocs

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.

Responsibilities:

• 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.

• DPEM 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.

• Subject Matter Expert is responsible for the oversight of material supply activities at External Manufacturers in support of the DPEM Q Staff.

Key Objectives/Deliverables:

• Oversee supplier complaint investigations, coordinate the investigation with the contract manufacturer and DPEM Joint Process Teams.

• Coordination of the communication of supplier change notification to the DPEM team members and ensure that the impacts are properly evaluated.

• Participate to Periodic Performance Evaluation of applicable suppliers

• Keep DPEM management informed of issues / progress, including internal notification to management of quality issues, when required.

• Follow-up on Corporate Quality Assurance (GQA – Auditing & compliance, GQAAC) audit findings, ensuring that the CM is taking appropriate action in the due time.

• Provide input to monthly reports to senior management.

• Assess DPEM change controls for potential supplier management activities impact.

• Maintenance of Approved Supplier List and supplier risk classification.

• Maintains SAP status for materials.

• Oversees the accreditation system for Direct Sourcing by contract manufacturers.

• Management of direct communication with non- direct source suppliers for primary components, e.g.: BD (glass barrels) and West (plungers and stoppers).

• Provide technical support for the management of non-direct source suppliers complaints and remarks, including participation in triage meeting and the opening of the complaint record in TW138.

• Build and maintain good communications with CMs and awareness of issues/progress, including reporting back to DPEM Management. Also, respond to requests for data and information.

• Participate in CM performance reviews, e.g. dashboard, profile (as required).

• Review, revise and maintain Product Specifications, material specifications and Quality Technical Agreements (QTAs).

• Assess CM capability for Direct Sourcing. Monitor supply of incoming materials and vendor approvals; carry out vendor audits as required.

• Perform inspection and GMP assessments of the distribution/warehousing premises and practices as required.

• Support CMs efforts to maintain and improve their quality systems.

• Participate on Lean initiatives to help improve productivity.

Relationships:

• All functions at the external manufacturers from senior management to shop floor personnel.

• Component platform team.

• QA for Procurement Auditing group.

• All relevant functions at the Lilly Geneva office, Lilly Global TS/MS, Lilly manufacturing sites and CMOs organization (API EMO).

• Global Quality Laboratory Group (GQL).

• Marketing Affiliate Quality Assurance (MAQA).

• Internal and External supplier/material networks (E.g.: Syringe platform team, Component platform team).

• GQAAC Auditing Group.

Basic Qualifications:

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

• 3+ years of experience in technical and quality functions within a manufacturing plant, ideally both in parenteral products and dry products.

Skills:

• Technical understanding of GMPs and the Global Quality Standards.

• Strong written and communication skills, especially attention to detail.

• 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.

• Willingness to learn new technologies.

• Capability to work in a virtual and complex environment.

• Appreciation for cultural diversity.

Additional Skills/ Preferences:

• Experience with Lilly systems (SAP, Trackwise, QDocs…etc.).

Additional Information:

• Shift is days, but off hours may be necessary to support operations.

• Travel is possible, up to 10 %.

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.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$63,000 - $162,800

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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