Sr. Associate-Commercial Quality

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:

The role of Commercial Quality (PC focus) is to be responsible for all Product Complaint activities related to Lilly products marketed in China, and APRC China Satellite Regional Center activities. The commercial quality responsibilities of the role are to carry out quality implementation, and ongoing oversight of China affiliate marketing or commercial programs initiated or supported by the affiliate, and oversight of Third-Party Organizations (TPOs) involved in these programs. 

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Affiliate Program Quality Oversight/Support of Marketing Portfolio or Commercial Programs and Third-Party Organization (TPO)

• Execute the risk-based oversight strategy of affiliate programs set by quality compliance, provide expertise and quality oversight to external parties of these programs, including but not limited to Call Center, PSP programs, Digital programs, Business Development (BD) programs, Market Access programs.
• Liaise closely with team members quality compliance to ensure all the programs are under a centralized quality governance framework and assigned with appropriate quality oversight approach compatible with its risk.
• Act as SME (subject matter expert) to maintain quality system processes and procedures (product complaint and commercial projects/initiatives related) to comply with Lilly global standards and regulatory requirements.
• Support internal audit and/or external inspections.
• Develop and update the quality training materials to improve customer awareness.
• Drive efforts and endeavors for continuous improvement in processes of marketing and commercial programs and associated TPOs' oversight.
• Establish and maintain good relationship with business partners and stakeholders.

China Affiliate RCP (Responsible Complaint Person) – Product Complaint

• Complaint Monitoring, Trending, and Process/SOP maintenance
  • Conduct periodic reconciliation of AE/PC events with Lilly internal/external business partners to ensure the timely case reporting and no missing PC cases.  
  • Develop and update PC related training or documents (e.g., local TRD) to support business.
  • Periodic PC metrics consolidation, data mining and trending analysis report, to monitor the post-launch product complaint trends/incidents that may indicate a potential quality or patient safety issue.
  • Provide onsite/offsite quality oversight (including training, hidden check, routine case reporting follow-up) to third party organization to ensure the case reporting in accordance with Lilly requirements.
  • Lead/Manage creation, revision of local complaint related processes and procedures, and/or AEPC templates of quality agreement in accordance with global policy, standards, guidance, and local regulatory requirements.
• Complaint Initiation, Follow-up, and Closure
  • Collect the complaint data, Identify the classification of report as a Product Complaint (PC), Adverse Event (AE), combined PC&AE, or inquiry according to Lilly defined criteria. Confirmation of receipt of any reports from third party organizations.
  • Case entry of accurately translated information into Product Complaint electronic database.
  • Follow up with Chinese reporters in terms of additional data collection and complaint sample retrieval request etc.
  • Work closely with Patient Safety, APRC and local/global cross-functional teams to handle complaint related activities or issues.
  • Monitor the case overdue status and ensure the incidents can be closed on time to meet Lilly requirements.
  • Complaint response (verbal or written format) to reporters based on the initial request.
  • Complaint sample management, receipt, shipment to APRC (Asia Pacific Regional Center) or manufacturing/packaging site for complaint investigation, and maintenance of SH office sample room facility.
  • Support suspect reporting of Lilly products.
  • Identify and escalate potential urgent reports to quality leadership.

APRC (Asia Pacific Regional Center) China Satellite Assessment and Analysis (pre-requisite of RCP experience and qualification)

• APRC China Satellite Regional Center Assessment
  • Assess product complaint information appropriately. (e.g., designate an appropriate complaint level, assign suitable complaint and/or analysis categories).
  • Determine the need for additional investigation and forward product complaint records to the proper manufacturing or packaging quality unit for further investigation, as required.
  • Where additional information may aid in determining the root cause of the product complaint, obtain supplementary information from related parties.
  • Determine the need for the product complaint sample.
  • Review and evaluate complaint records for completeness and compliance with Global Quality Standards Product Complaints.
  • Establish working relationships and influence outcomes with manufacturing/packaging sites that supply device or medicine/device combination products such as Humapen Ergo II, or Miriopen/KwikPen, Auto-injectors to China to deliver timely complaint investigations.
  • Work effectively within a team to deliver results in a defined timeline and manage the operation.
  • Participate in departmental process improvement activities.
  • Comply with local regulations at the site where the individual belongs to.
• APRC China Satellite Regional Center Sample Analysis
  • Receive product complaint samples returned to APRC China satellite sample room.
  • Perform visual and/or functional analysis of returned complaint samples such as Humapen Ergo II, Miriopen/KwikPen, Auto-injectors.
  • Document analysis results into the complaint database and associated records.
  • Assess the results of the returned complaint sample appropriately. (e.g., including impact on complaint level; complaint categories; investigating site; and additional investigation requirements)
  • Forward complaint record and sample/photos to the appropriate manufacturing or packaging site for further investigation, as appropriate.
  • Respond to China affiliate RCP with educational information, as applicable, during follow up endeavours.

Minimum Qualification Requirements: 

• Bachelor's degree or above in Science, Engineering, Pharmaceutical Science, or related technical discipline
• At least four years of regulated industry experience (GMP/GSP/GCP/GLP) with demonstrated knowledge of related quality systems.
• Strong Lilly product knowledge relating to how products work medicinally and functionally.
• Strong attention to detail with excellent data documentation skills.
• Strong verbal and written communication skills in English
• Solid teamwork, collaboration, and interpersonal skills.
• Self-management/motivated with an ability to work independently within a structured process.
• Good computer literacy and computer skills - specific training relating to software used will be provided.
• Strong curiosity skills with the ability to question/identify issues & work to resolution.
• Strong critical thinking/problem solving skills with an ability to apply rationale.
• Proven ability to pay attention to detail with excellent data documentation skills.
• Ability to mentor/train others – share learning.
• Must be able to work in an area with known allergen.
• Must be knowledgeable of laboratory waste disposal and laboratory safety.

Other Information/Additional Preferences:

• One to two years of Laboratory Quality System experience should be preference.
• Experience writing requirements documents (e.g., procedures) and developing training materials.
• The APRC China Satellite Investigator will work in an office environment with potential exposure to the contents of returned product complaint samples.
• Responsibility for after-hours and long holiday (e.g., year-end, summer vacation) coverage may be required.

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