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Medicines Quality Consultant (MQC)

46543
Medicines Quality Consultant (MQC)
Cork
Cork
Europe; Middle East; Africa
Ireland
Global
At Lilly, we make a difference for people the world over by discovering, developing and delivering medicines that help people live longer, healthier and more active lives. Central to all that we do are our talented and motivated professionals, circa 500 of whom are based at our Global Business Solutions centre in Little Island, Cork. There we boast vibrant workforce made up of over 35 nationalities, speaking over 27 languages.
Established in 2010 to gain efficiencies in areas such as General Accounting, Purchase to Pay and Order to Cash, the GBS Cork quickly excelled in its financial mandate, allowing the Cork leadership to ask, how can we apply these processes to other areas of the business? And so the GBS we have today was born, still leading in finance, but also evolving and expanding into diverse Business Service functions including Customer Meeting Services, Global HR Data Management, Medical Information and more to come on stream across 2018 and 2019.
This, along with the current physical expansion of the Little Island campus, means there has never been a more exciting time to be part of the GBS story! Mirroring the existing Island House building, the new Island Hall facility will extend our overall capacity where Lilly will continue to offer a premium workspace across both buildings, complete with healthcare, pension and life assurance benefits, subsidised canteen, wellbeing facilities, travel subsidies, car-pooling incentives, bike to work scheme, on-site parking and much more.
At the GBS, it’s not just about what we do today, but how we can continuously improve and innovate for present and future operations. We view the development of our highly skilled workforce in much the same way and want to grow your role into an empowering and fulfilling career here at Lilly. Therefore, with the sole purpose of employee progression, weekly Manager 1:1s, a dedicated Learning & Development service and Educational Assistance schemes all await you.
Above all, it’s about being part of an open, welcoming and inclusive culture, one that is further enhanced by the dedication of our committees - Culture Club, Diversity & Inclusion, Sports & Social, Corporate Social Responsibility, Health Safety & Environment and Food.
“We see Cork as an integral part of our productivity agenda. If you are excited by new opportunity and new scope, you are working at the right place.” – Dave Ricks, CEO Lilly
The purpose of the Medicines Quality Consultant (MQC) role is to support the development and implementation of quality systems strategy and activities to support Medicines Development Unit (MDU) and Trial Capabilities (TC) goals and objectives for assigned countries. In support of this mission, the purpose of the role of MQC is to act as a quality consultant and leader in integrating the quality requirements into the business processes of TC (such as activities related to trial set up, trial maintenance including regulatory and institutional submissions). The MQC will implement the quality plan and ensure consistency between the global requirements and local requirements. This includes the implementation of Standard Operating Systems (SOPs) and assuring that this system is aligned with appropriate quality and regulatory requirements. The MQC will provide updates on internal/external GxP trends and changes through Integrated Quality Lead Team (IQLT) (where applicable).The MQC will act as a contact person regarding quality and business process compliance concerns between the function supported and global.
  1. Ensure local implementation of the Quality System
    1. Review regional and/or local SOPs versus global policies. Reviews SOPs documents and provides feedback.
    2. Approve regional and/or local procedures, job aids, forms, templates.
    3. Recommend new procedures or changes to existing procedures where applicable.
    4. Provide quality oversight for compliance to SOPs
    5. Escalate compliance issues to management locally and globally as appropriate,
    6. Provide support for outsourced activities in alignment with internal standards
  2. Ensure inspection readiness and compliance to global, regional, and/or local regulations
    1. Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates
    2. Perform quality self-assessments
    3. Facilitate audits and inspections
    4. Coordinate audit responses including Trackwise system documentation
    5. Communicate and ensure inspection readiness requirements are in place; e.g. organization and availability of documents such as training records, job description, backroom and/or front room organization, etc.
  3. Ensure the implementation and maintenance of Quality Plan(s)
    1. Document the quality systems requirements ensuring clear accountabilities.
    2. Manage the quality plan(s).
    3. Provide updates to quality and business owners.
  4. Implement and manage Quality Systems
    1. Provide consultation on the integration of quality into business processes.
    2. Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
    3. Conduct root cause analysis and implement Corrective Action and Preventative Action (CAPA) process
    4. Drive trending of metrics to improve processes and compliance
      1. Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
      2. Monitor completion of deviations, CAPA related to deviations and change controls.
      3. Monitor completion of audit responses through metrics.
      4. Provide updates to management.
      5. Share key learning to drive simplification and replicate best practices in the region and globally.
      6. Coordinate quality improvement initiatives.
      7. Seek and implement simplification and process improvement.
    5. Other responsibilities
      1. Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections).
      2. Understand the roles and responsibility of the EU qualified person
46543BR
  • Bachelors or Masters Degree in a science or health care related field, Health care professional, i.e., Pharmacist, Nurse.
  • Three years experience in quality and/or regulatory/clinical operations/medical affairs.
  • Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (e.g. GCP, GvP).
  • Demonstrated ability to communicate effectively, both written and verbal, and to influence others
  • Demonstrated ability to prioritize and handle multiple concurrent tasks
  • Demonstrated ability to apply risk-based decision making in a regulated environment
  • Demonstrated ability to work in a global environment
  • Cultural sensitivity
  • Based in Cork, Ireland
  • Ability to travel