Senior Associate - QA

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.

The role will suit people with Quality Assurance experience of drug product manufacturing and batch disposition. The role is varied and can involve being responsible for all quality activities related to the start-up of a new External Manufacturing relationship and/or the support to existing relationships for new products as well as established products.

MAIN RESPONSIBILITIES

To act as the primary Lilly quality contact for the following:

Provide quality support for existing products / existing External Manufacturers (EM)

The roles and responsibilities are broad and varied and may include:

• Ensure EMs are following appropriate quality systems as part of routine operations e.g. change control and deviation management. Use regular visits, JPT and other communications to help monitor/assess performance.
• Build and maintain good communications with EMs and awareness of issues/progress, including reporting back to Drug Product External Manufacturing Management. Also, respond to requests for data and information.
• Make regular visits to EMs to ensure current awareness of their operations and maintain a strong working relationship, produce a visit report for any trips made.
• Quality systems execution:
  • Perform Lilly batch dispositions - approve and provide appropriate documentation.
  • Responsible for the evaluation and management of deviations through the appropriate DPEM/local affiliate and External Manufacturer quality systems, including evaluation/management of deviations for regulatory impact.
  • Responsible for the evaluation and management of change controls through the appropriate EMEAA/local affiliate and External Manufacturer quality systems, including evaluation/management of change controls for regulatory impact.
  • Investigate and monitor product quality complaints, in conjunction with TSMS.
  • Provide guidance to EMs on resolution of technical/quality issues, in conjunction with TSMS.
  • Manage implementation of laboratory accreditation for analytical methods including appropriate analytical transfers.
  • Participate in the development of Annual Product Reviews (APRs) and Periodic Quality Evaluations (PQEs), in conjunction with Technical Services & Manufacturing Science (TSMS).
  • Determine the appropriate stability program, manage it to plan and perform periodic evaluation of the data for products manufactured at EMs, and compare to those made at other sites.
  • Perform internal notification to management of quality issues where needed.
  • Assess EM capability for Direct Sourcing. Monitor supply of incoming materials and vendor approvals; carry out vendor audits as required.
  • Review, revise and maintain Product Specification Data Sheets (PSDSs), material specifications and Quality Agreements (QAs) or maintain oversight if these are the responsibility of another Lilly site.
  • Participate in the development of Master Batch Records, Packaging Orders, Process Validation Protocols and Reports in conjunction with TSMS and review any updates.
  • Continuously identify areas for quality improvements in for example buildings, premises, personnel, training, procedures. Manage improvements through the GMP Plan process, supporting/leading EM through the development and preparation of the Plan. Ensure EM completes actions in a timely manner.
  • Ensure EM is aware of any changes in quality and/or technical requirements and arrange training where appropriate in conjunction with GQAAC/TSMS.
  • Responsible for corrective action tracking.
• Build and maintain good communications with local Lilly affiliates. Also respond to requests for data and information.
• Participate in EM performance reviews i.e. metrics, supply management.
• Participate in or lead Joint Process Team(s) and/or Alliance Management as required.
• Participate in or lead After Action Reviews as requested, and feedback to the EMEAA Lead Team.
• Follow-up on Global Quality Assurance Auditing & Compliance (GQAAC) audit findings, ensuring that the EM is taking appropriate action in due time.
• Perform inspection and GMP assessments of the distribution/warehousing premises and practices as required.

Provide quality support for commercialization of new products / new EMs and for additional capacity implementation for existing products at existing EMs.

Participate and lead quality activities as appropriate under the Quality Assurance role. This may include:

• Work in conjunction with TSMS, Commercialization Teams, Regulatory Teams and Lilly sites to establish and implement plans for the successful execution of projects at EMs. Provide QA guidance as needed to the project team.
• Assess capabilities of existing EMs to produce additional products, particularly with regard to quality topics (for example segregation, cleaning validation, skills of the EM staff, procedures, training).
• Assess new EMs, particularly with regard to their level of implementation of Product Quality Systems and recommend their suitability as a future partner.
• Ensure that appropriate compliance documentation is put in-place, such as qualification and validation protocols (and ensure their approval prior to the start of manufacturing operations). Also, put in-place documentation for the commercialization of batches manufactured during process validation. Ensure that project documentation and reports are completed to an appropriate standard, within agreed timelines.
• Responsible for the preparation of Quality Agreements and subsequent maintenance/improvement.
• Review, revise and maintain PSDSs, Material Specifications and Quality Agreements, or maintain oversight if these are the responsibility of a Lilly site.
• Produce audit qualification reports, as appropriate, and review process validation reports.

General

• Review, revise and maintain DPEM Standard Operating Procedures (SOPs).
• Co-operate with GQAAC in the preparation of Lilly standards and implement at EMs.
• Provide input for monthly reports and metrics.
• Act as a Subject Matter Expert (SME) within DPEM ensuring full understanding of requirements, able to provide expert guidance to DPEM/External Manufacturers as appropriate.
• Ensure that Quality Backlog is appropriately managed and issues escalated as necessary.

REQUIRED QUALIFICATIONS/CHARACTERISTICS

• Graduate in Chemistry, Pharmacy, or other similar technical background.
• Significant experience in technical and quality functions within a manufacturing plant, ideally in parenteral products (syringes and/or vials).
• Appreciation of cultural diversity.
• Willingness to travel.