Sr Associate/Principal Associate, IT Systems Business Quality Assurance - Pharmacovigilance

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.

Senior Associate/Principal Associate, It Systems Business Quality Assurance (Bqa) - Medicines Quality - Safety/Pharmacovigilance

Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.

Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Purpose

The purpose of the Associate/Senior Associate/Principal Associate, IT Systems Business Quality Assurance (BQA) – Safety/Pharmacovigilance role is to support the development and implementation of quality systems strategy and activities to support Global Patient Safety (GPS) goals and objectives for safety IT systems. In support of this mission, the purpose of the role of BQA-Safety/Pharmacovigilance is to act as a quality consultant and leader in integrating the quality requirements into the business processes.  The BQA-Safety will implement the quality plan and ensure consistency between the global requirements and local requirements.  This includes the implementation of safety quality systems and assuring that these systems are aligned with appropriate quality and regulatory requirements.  The BQA-Safety will act as a contact person regarding quality and business process compliance concerns with GPS IT Systems.

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 supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

1. Ensure local implementation of the Safety and Efficacy Quality System (SEQS)

• Review regional and/or local SOPs versus global policies.  Review quality system documents and provide feedback.
• Recommend new procedures or changes to existing procedures where applicable.
• Provide quality oversight for compliance with SEQS.
• Escalate compliance issues to management locally and globally as appropriate.

2. Ensure inspection readiness and compliance with global, regional, and/or local regulations.

• Assist in interpreting relevant pharmacovigilance regulations and guidelines and acts as a contact person in the regional center and/or affiliates.

• Perform Quality Self-Assessments.

• Facilitate audits and inspections.
• Coordinate audit responses including Trackwise system documentation.
• 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 regional and/or affiliate Quality Plan(s)

• Document the regional and/or affiliate quality systems requirements ensuring clear accountabilities.
• Manage the regional and/or affiliate quality plan(s).
• Provide updates to quality and business owners.

4. Implement and manage Quality Systems

• Provide consultation on the integration of quality into business processes.
• Support the business on the application and facilitation of quality systems (deviations, notification to management, change control).
• Consult on root cause analysis for deviations.

1. Drive trending of metrics to improve processes and compliance.
2. Information Technology Quality Support responsibilities

• Analyze trends, identify areas of weaknesses/gaps, and recommend corrective actions.
• Monitor completion of deviations, CAPA related to deviations and change controls.
• Monitor completion of audit responses through metrics.
• Provide updates to management.
• Share key learning to drive simplification and replicate best practices in the region and globally.
• Coordinate quality improvement initiatives.
• Seek and implement simplification and process improvement.
• Review, and approve as appropriate, documents associated with the development and maintenance of GPS IT systems.
• Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
• Participate as a member of the GPS IT Change Control Board.
• Coordinate interfaces with other related systems.

7. Other Responsibilities

• Understand the handling of confidential information (patient privacy, confidential audits and regulatory inspections).
• Understand the roles and responsibilities of the EU qualification person.
• Review and approve change requests and validation documentation for GPS IT systems.

Minimum Qualification Requirements

• Bachelors or Master’s Degree in a science or health care related field.
• Three years’ experience in quality and/or pharmacovigilance.
• Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (GCP etc.).
• 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.

Other Information/Additional Preferences

• Demonstrated ability to work in a global environment
• Systems validation experience

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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