DPEM QA Data Steward

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

Job summary

A leading company in the pharmaceutical industry seeks a QA Data Steward to oversee quality assurance processes and maintain compliance. The role requires strong experience in quality systems and data management, with a focus on improving business processes and supporting customer service interactions. The position offers a competitive salary and comprehensive benefits, emphasizing the importance of quality oversight in drug manufacturing.

Benefits

Company bonus

401(k) participation

Pension benefits

Medical benefits

Dental benefits

Vision benefits

Flexible spending accounts

Life insurance

Employee assistance program

Qualifications

• 5+ years of experience in a QA role with DPEM experience.
• Experience as a power user or data steward for SAP, TrackWise, and Veeva QDocs.

Responsibilities

• Support the implementation and maintenance of quality systems.
• Lead, mentor, and coach DPEM personnel on quality systems.
• Review and approve GMP documents to ensure quality attributes are met.

Skills

Data Stewardship

Quality Assurance

Technical Writing

Education

Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field

Tools

SAP

TrackWise

Veeva Q Docs

Darwin

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 (DPEM) 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.

Responsibilities:

The QA Data Steward is responsible for improving business processes and supporting customer service interactions to ensure key business objectives are met. The QA Data Steward is also responsible for activities that include SAP master data, change controls, non-conformance investigations, procedure revisions, impact assessment reviews, management of specifications, review and approval of cGMP documents, and maintaining regulatory compliance.

Key Objectives/Deliverables:

• Support the implementation, validation and maintenance of the software based computerized quality systems for DPEM

• Power User for IT systems supported by QA including SAP, TrackWise, Document Management (Veeva Q Docs), & Darwin

• Create and manage quality master data in SAP including q-info records and inspection plans for materials

• Protect the integrity and accuracy of data to be entered into the quality systems, perform data identification and reviews as required

• Lead, Mentor and Coach DPEM personnel on the quality systems

• Responsible for DPEM compliance area documents, including specifications and procedures

• Partners and builds relationships with Global Quality Network and Global IT team members

• Provides oversight and supports continuous improvement of quality systems

• Effectively review/approve GMP documents to ensure quality attributes are met (i.e.: Non-conformances, procedures, protocols, specifications, and change controls)

• Participate in self-led inspections and/or provide support during internal/external regulatory inspections

Basic Qualifications:

• Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience

• 5+ years of experience in a QA role with DPEM experience and with use of SAP, DEEVA or similar software

• Experience as a power user or data steward for Kneat, Trackise, SAP, Veeva QDocs, and Darwin

• Knowledge of operations business processes, such as batch disposition, materials management, laboratory specifications and methods

• Previous equipment qualification and process validation experience

• Previous experience with SAP or other inventory management systems

• Previous experience with device and parenteral product materials

Additional Skills/Preferences:

• Experience working in the pharmaceutical or medical device industry in QA roles

• Previous GMP data stewardship experience

• Proficiency with GMP computer systems including Lab systems, CAPA systems, and Document Control systems

• Demonstrated strong technical writing skills

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and DPEM Goals

• Previous regulatory inspection readiness and inspection execution experience

Additional Information:

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

• Some travel (<10%) may be required.

• This role requires on-site presencea minimum of 4 days per week. In order to fulfill this on-site commitment, employees are expected to travel (by car) 4+ times/week to the site. Relocation is available.

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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