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.

Associate Director / Director, Global Medicines Quality Organisation

Purpose

The Associate Director / Director, Global Medicines Quality Organisation (GMQO), leads a team of quality professionals responsible for quality systems, quality oversight and consultation across Medical (Clinical Development and Medical Affairs), Safety and Regulatory activities conducted within assigned functions and/or affiliates in the International Business Unit. This includes the development, execution and oversight of quality systems, management of audit and inspection activities and monitoring of internal metrics and the external environment to maintain compliance to external regulations/internal standards and drive continuous improvement. The role will collaborate with quality, business partners and leadership both locally and across regional/global functions to deliver a robust affiliate quality strategy. The Associate Director / Director will be responsible for a team of GMQO representatives including recruitment, onboarding, coaching and performance management to achieve GMQO objectives and develop talent within the organisation.

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.

1. Leadership for Quality initiatives, Oversight and Continuous Improvement

• Develop and implement the strategy to assure that appropriate quality systems (such as: procedures, notification to management, change control, deviations, document management), are aligned with Lilly and external requirements, and integrated with business processes across Medical, Safety and Regulatory for assigned functions and/or affiliates.

• Establish and oversee the local affiliate quality system across Medical, Safety and Regulatory ensuring appropriate interface between global and affiliate functions (such as Product Quality, Ethics and Compliance, Marketing).

• Define, track and report quality metrics that will enable functional, affiliate and global leadership measure objectively the effectiveness of the quality systems and develop initiatives for continuous improvement.

• Partner with GMQO representatives, Global Quality Auditing and Compliance (GQAAC) and business partners to ensure timely review, input and approval (where applicable) of local quality plans, risk assessments, self-inspection and audit planning activities.

• Provide quality advice and define best solutions in support of decisions related to Medical, Safety and Regulatory compliance and be accountable for quality decisions.

• Assure appropriate monitoring of the external regulatory environment to assess changes in requirements and to influence the future direction of activities within Lilly.

• Represent quality in functional leadership and governance meetings for Medical, Safety and Regulatory. As a member of these forums, the Associate Director / Director is expected to identify and recommend plans to drive continuous improvement.

2. Management of audit and inspection activities

• Provide resources and leadership for inspection/audit readiness activities and the management of inspections/audits at affiliates, investigator sites and third-party organisations within assigned regions.

• Work with senior leadership, affiliates and functional areas as appropriate to ensure clear understanding of expectations regarding inspection/audit readiness and to identify and address areas of inspection/audit risk.

• Provide leadership and collaborate with GMQO representatives, business partners and GQAAC to input into audit plan delivery and adjustments, audit scope setting and review/approval of audit responses and associated actions.

3.  Leadership and People Development

• Maintain a staffing model to meet current and future needs, understanding and anticipating required future skills.

• Ensure the optimum structure to accomplish goals and develop talent.

• Ensure staff are highly trained in the focus areas of quality and the areas of the business they support.

• Fulfill role in the Performance Management process and ensure a robust succession plan for critical skill jobs.

• Actively coach and mentor talent across the quality organization.

• Lead the GMQO ensuring the integration between Medical, Safety and Regulatory and establish a network to ensure sharing of best practices and learning.

• Through metrics and self-inspection, determine if affiliates have appropriate processes and personnel in place to meet both local and global Medical, Safety and Regulatory requirements, achieve functional and business objectives and escalate issues to senior management as appropriate.

• Participate as needed in business planning, ensuring the Quality needs are represented.

4. Minimum Qualification Requirements

• Bachelor’s or Master’s degree in a health or science-related field at a minimum.

• A minimum of 7 years of direct experience with Clinical Operations, Medical, Safety or Regulatory.

• Experience with quality issue resolution and regulatory inspection.

• Experience working directly with affiliates.

• Demonstrated leadership.

• Demonstrated decision making skills.

• Able to evaluate business needs and develop strategic plans regarding quality improvement.

• Demonstrated ability to operate across boundaries and influence others.

• Strong problem-solving and communication skills (both written and verbal).

• Strong teamwork and interpersonal skills.

• Self-management and motivational ability.

• Customer focused, flexible/adaptable.

• Process improvement oriented.

• Must be able to work autonomously.

Other Information/Additional Preferences

• Ability to travel

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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