Sr. Director- GQA Global Medical Regulatory Safety

Lilly • Indianapolis, IN

4d • $163,500 - $239,800 • Onsite

About The Position

The Sr. Director leads Global Quality Auditing (GQA) teams responsible for audits across Clinical Development (GCP); ATPLV functions including ADME, Toxicology, PK/PD, Laboratory for Experimental Medicine, and Veterinary Resources (GLP); Global Patient Safety/Pharmacovigilance (GVP); Regulatory Affairs; and Product Quality. The role also oversees GxP audits of operations in Lilly affiliates. Audits assess whether company-sponsored research and product and disease-state information shared with customers comply with company policies, procedures, regulations, and guidelines.

The role provides strategic input to the GQA audit program and works with global quality leadership and business stakeholders. The Sr. Director monitors internal business priorities and external regulatory expectations and identifies continuous improvement priorities. The position leads global quality auditors, sets audit strategy and plans, manages resources and budgets, and supports the development and performance of the team.

The position is located at Lilly Corporate Center and involves occasional domestic and international travel, sometimes on short notice, with a stated travel percentage of 0–10%.

Requirements

• Bachelor’s degree or equivalent in a scientific or health-related field.
• At least five years of relevant industry experience in quality, clinical development, safety, or regulatory affairs.
• Prior line-management experience.

Nice To Haves

• Advanced degree (Master’s or doctorate) in a scientific or health-related field.
• Experience in multiple facets of drug development, particularly clinical research, pharmacovigilance, regulatory affairs, and product development.
• Experience in Quality Assurance or auditing.
• Deep understanding of quality systems and business process management.
• Demonstrated ability to collaborate across boundaries and achieve results with internal and external partners.
• Experience leading change.
• Demonstrated ability to recruit and develop top talent.
• Ability to interpret and apply regulations, regulatory guidance, codes, and public expectations, and identify and recommend compliance changes as appropriate.
• Proven ability to synthesize information from multiple sources and make risk-based decisions.
• Excellent interpersonal skills and ability to remain constructive and influential with peers, management, and senior leadership, including in difficult situations.
• Ability to communicate professionally, clearly, precisely, and promptly, both orally and in writing, to all organizational levels.
• Ability to work independently and collaboratively within a global team.
• Good analytical and problem-solving skills.

Responsibilities

• Lead GQA teams conducting audits across Clinical Development, drug development functions, Global Patient Safety/Pharmacovigilance, Regulatory Affairs, Product Quality, and Lilly affiliates.
• Provide strategic input to the GQA audit program and interact with global quality leadership and business-unit stakeholders.
• Monitor internal business priorities and external regulatory expectations and identify continuous improvement efforts.
• Understand business needs and focus resources and quality improvements on high-risk activities.
• Lead the definition of quality strategy and GQA audit plans for areas of responsibility, applying risk-management principles to cover key risks across processes, procedures, facilities, investigational sites, laboratories, and third-party collaborations.
• Assess whether data supporting pharmaceutical product registrations were generated according to applicable regulations and company policies and procedures, and communicate potential gaps to senior management in a timely manner.
• Review audit findings and trends, identify areas for improvement in Clinical Development, Regulatory, Safety/Pharmacovigilance, and Product Quality, and escalate issues appropriately.
• Verify that vendor work complies with Lilly and external regulatory quality requirements.
• Engage with pharmaceutical company peers and agency staff to understand regulatory changes and adapt company policies and procedures to regulatory expectations.
• Manage and lead global quality auditors in implementing the GQA audit program and supporting business operations.
• Participate in component-wide QA strategic planning and develop action plans to strengthen GQA in support of company goals.
• Network with LRL functional business-area management to assess the impact of quality strategy and identify operational synergies.
• Participate in the GQA lead team, contribute to key decisions, and help set the component’s strategic direction.
• Participate in GQA business planning and manage budget and headcount to meet targets.
• Allocate people and finances to use and develop talent and expertise efficiently while balancing audit demands with GQA capacity.
• Ensure sufficient technical resources and an appropriate organizational structure, with the education, experience, and training needed to execute audit plans and support relevant business and quality areas.
• Work with direct reports to establish challenging departmental and individual objectives and ensure use of global performance-management processes.
• Work with managers and other direct reports to ensure team members have development and career plans, and provide timely feedback and coaching.
• Maintain quality-assurance knowledge and technical expertise to support strategy development and decision-making.

Benefits

• Company bonus for eligible full-time-equivalent employees, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior