Business Analyst, External Quality

3 weeks ago

Louisville, United States Planet Pharma Full time

1 year contract, pay $85-$91.76/hr


About the role:


We are in business for life. Every day, patients all over the world are helped by life-saving medicines that the Pharma Technical Operations (PT) organization manufactures and distributes. Ensuring that every single dose meets the expectations and standards for safe usage is the primary focus of our global Quality organization, and our Quality team at the Kentucky Distribution Center (KDC) completes the final steps before products can be delivered to patients.

This Business Analyst, External Quality (contractor) position is an operational role in the Quality team at KDC, our primary North American logistics and distribution hub. This role is part of a globally connected team within the External Quality organization supporting the company's network of distribution and transportation activities.

One of the teams critical responsibilities is to ensure the successful implementation of master data and business-critical Quality processes in an ERP evolution (SAP ECC to S4/Hana), which would be your primary area of responsibility. More generally, our KDC team provides the final confirmation that internally and externally (CMO) manufactured life-saving products comply with Quality requirements before being released to patients via distributors and hospitals. Other responsibilities include ensuring site clinical and commercial supply distribution operations and contractors comply with cGMPs, cGDPs and Quality Agreements. In addition to supporting the systemic ERP evolution, as a Business Analyst within our team you would be a key enabler of opportunities to automate or streamline existing processes and procedures.


This role is responsible to:

  • Provide input and support in defining the data migration strategy for Quality-related data. Ensure the quality and accuracy of all Quality data migrated from legacy systems to the new S4 platform.
  • Own and define the content and structure of Quality-related data in the source systems.
  • Review and confirm data matching processes to ensure accuracy and consistency.
  • Act as a key point of contact for local Quality data issues and work with global teams to resolve discrepancies.
  • Contribute to data validation and testing efforts during the S4 implementation to ensure data integrity.
  • Maintain alignment with the overall data governance framework and ensure adherence to Quality data standards.
  • Support/lead continuous improvement opportunities related to Quality applications/systems (SAP, Veeva, etc.) Actively seek opportunities for quantifiable efficiency gains through automation/simplification.
  • Act as Point of Contact for End User/business stakeholders in terms of business requests and IT related issues.
  • Monitor and improve stakeholder and user experience and ensure strong support of Product Release in collaboration with Supply Chain Business Partners.
  • Familiarity with Product Release/Lot Disposition process is a strong plus.
  • Support site audits and inspections, planned/unplanned events, implementation of corrections, etc. as a Subject Matter Expert.


Who you are:

  • Must have experience in Quality for biotech/life sciences/pharmaceutical manufacturing.
  • Business domain knowledge in Biopharmaceutical or similar Manufacturing domain.
  • Knowledge of Good Manufacturing Practices (GMP), Health Authority practices, 21 CFR Part 11, cGMP Annex 11, Data Integrity principles. 7+ years of experience with SAP ECC, experience or familiarity with SAP S4 HANA is a plus.
  • Support and troubleshooting of applications, primarily focused on SAP ECC and S4 but could expand to other systems.
  • You can identify, analyze, and solve complex technical issues. Strong business acumen and ability to prioritize value delivery.
  • Strong analytical skills for effective troubleshooting and problem solving.
  • Excellent customer service skills and delivery through agile mindset, stability, flexibility, and speed. Can identify opportunities to create additional value and improve business processes and patient outcomes, and efficiently deliver the benefits of standardization of technologies
  • Lean-Agile Mindset with focus on Continuous Improvement. Familiarity with Lean Production System fundamentals is a plus.
  • Proactive thinking; open minded curiosity, eagerness to learn. Inclusive mindset.
  • Able to communicate clearly and professionally both in writing and verbally. Can summarize and prioritize information for efficient, effective messaging. Bachelors Degree
  • Onsite at the Kentucky Distribution Center

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