Associate - GMP Compliance Global Marketing Affiliates Quality Assurance

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.

Purpose of the position

The QA Associate GMP Compliance, Quality Assurance Global Marketing Affiliates, is responsible for expertise on the GMP responsibilities of the Marketing Authorization Holders. She/he is also responsible for the preparation of the APR (Annual Product Review) for EU Affiliates on behalf of the Marketing Authorization Holder (MAH) wherever required by local authorities/EMA. She/he is also responsible to support other non-EU Affiliates in the preparation of the APR, as required by the local regulation.

The Associate is responsible to coordinate with other resources as the Sites and the DPEM (Drug Product External Manufacturing) quality group to ensure the APRs are prepared, evaluated, and approved in time and to cooperate with Global Regulatory Affairs (GRA) to get all the required information, and to clarify any issue, if needed. Provides support to the EU Affiliates in case of inspection/audit about APRs and GMP responsibilities of the MAH. This role also manages the related documentation. This role also includes the responsibility of other activities under the GMP Compliance Team.

Key elements of the Role

• Owner of the MAQA documentation for EU Affiliates about EMA requirements on MAH GMP responsibilities
  • Procedure on APRs - GMA-SOP-QA-PRD-119109 “Evaluation and assessment by MAH of product APR developed by Site”                                                         
  • Lilly Position Paper explaining the quality system in place at MAH level in European Lilly Marketing Affiliates
  • Quality Agreement between the MAH and MFG sites
  • Quality Agreement between the EU Central MAH and local representatives
  • Point of contact for any enquiry/support about APRs
  • Document periodic review (every 3 years)
  • Leading optimization projects related to APRs

• Quality tasks
  • Manage Change Controls within GMP Compliance Team
  • Manage Deviations within GMP Compliance Team
  • Prepare year APR Plan within the Central MAQA Quality Plan at the beginning of the year and complete within the due date each activity
  • Support other Quality compliance activities of the team and APR review for affiliates outside of EU Escalate product quality related issues to the appropriate Affiliate’s/Site’s Management
  • Collaborate to Annual Quality Plan preparation.
  • Handle quality issues if needed during APR preparation or when applicable.

• Audits and Inspection readiness

  • Support the EU Affiliates in the preparation of inspection/audit about GMP responsibilities of MAHs,

  • Participate to the periodic holistic review / self inspection to EU Affiliates when needed.

  • Participate, during the audit/inspection in backroom roles if required. Capture trends from audit/inspection observations to EU Affiliates related to this topic to evaluate it the process must be improved

• Quality metrics
  • Prepare quarterly reports to verify the APRs for EU Affiliates prepared and approved in time
  • Provide details and follow up on potential quality trends identified in the APRs for EU Affiliates

• Collaborate both internally and with business partners to identify opportunities to optimize the process for APR review for EU Affiliates, increase harmonization with Affiliates outside of EU, and identify improvement opportunities.

  May lead project and continuous improvement activities related to GMP Compliance area.

Technical Skills

Depth expertise in quality assurance and/or GMP and Lilly Quality System, Manufacturing Sites processes, Manufacturing IT systems (Trackwise, iAPR, Veeva QDocs)

Soft Skills

• Proven ability to establish and maintain efficient and robust relationships with the Manufacturing Sites, Regulatory, Affiliates, Global Groups
• Ability to quickly learn using new IT systems
• Sense of urgency
• Ability to assign the right priorities to activities
• Capability to carry responsibility and work under pressure

Requirements needed

• Bachelor’s degree
• At least 2 years of experience in a pharmaceutical company within the Quality unit, compliance, regulatory or laboratory, preferably with exposure to APR preparation and agility with different IT systems
• Fluent in English, written and verbal
• Flex hours possible – may work with global groups in different time zones

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 does 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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