Sr. Director- GQA Global Medical Regulatory Safety

100 Eli Lilly and Company; Indianapolis (IN); On-site; USD 164,000 - 240,000; Full time

Benefits offered by this job

401(k)

Pension

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Time off and leaves

Well-being benefits

Job summary

Lilly, headquartered in Indianapolis, seeks a Sr. Director - GQA Global Medical Regulatory Safety to lead audits across Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality.

You will shape the audit program, drive risk-based strategies and align with global quality leadership. Manage a global team of quality auditors, partner with senior leaders to close gaps, and ensure compliance with GMP, GLP and current regulations while supporting Lilly’s corporate goals.

Qualifications

• Education: Bachelor’s Degree or equivalent in a scientific or health-related field.
• Experience: Minimum of five (5) years relevant industry experience in quality, clinical development, safety or regulatory affairs.
• Prior line management experience.

Responsibilities

• Lead the definition of the quality strategy and GQA audit plans for the areas of responsibility.
• Apply risk management principles to make certain the audit plans adequately cover the key risks of Lilly processes, procedures, and facilities, investigational sites, laboratories and contract research organizations, as well as other third-party collaborations.
• Assess whether data reported in support of registration for pharmaceutical products were generated according to applicable international / national regulations and the required corporate policies and procedures.
• Communicate any potential gaps to senior management in a timely manner.
• Based on review of audit findings or trends, highlight key areas for improvement within Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality, with appropriate escalation of issues.
• Verify that work performed by vendors complies with Lilly and external regulatory quality requirements.
• Through engagement with pharmaceutical company peers and agency staff, seek to understand the changing regulatory environment, and proactively adapt work and company policies and procedures to align with regulatory expectations.

Skills

Quality auditing

Regulatory affairs

Leadership

GCP/GLP knowledge

Education

Bachelor’s Degree or equivalent in a scientific or health-related field

Advanced degree (Masters, Doctorate)

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Sr. Director- GQA Global Medical Regulatory Safety Responsibilities

This role leads the Global Quality Auditing (GQA) teams responsible for executing audits of operating units in Clinical Development (GCP), ATPLV: ADME (Absorption, Distribution, Metabolism, and Excretion), Toxicology, PK/PD (Pharmacokinetics/Pharmacodynamics), LEM (Laboratory for Experimental Medicine), Veterinary Resources (GLP), Global Patient Safety/Pharmacovigilance (GVP), Regulatory Affairs and Product Quality, including conducting GxP audits of operations in Lilly’s affiliates. These audits serve to ensure that research conducted and sponsored by the Company, as well as product and disease state information shared with customers are in accordance with Company policies, practices and procedures and in compliance with current regulations and guidelines. The broad scope of auditing managed by the Sr. Director requires that the Sr. Director provides strategic input to the overall GQA audit program and interacts effectively with global quality leadership and business unit stakeholders. The Sr. Director is responsible for staying abreast of the changing environment, both internal business priorities and external regulatory expectations, to identify and focus continuous improvement efforts.

Key Objectives/Deliverables

• Compliance Understand the strategic and operating needs of the primary business areas to ensure that resources and quality improvements are focused on high-risk business activities.
• Lead the definition of the quality strategy and GQA audit plans for the areas of responsibility.
• Apply risk management principles to make certain the audit plans adequately cover the key risks of Lilly processes, procedures, and facilities, investigational sites, laboratories and contract research organizations, as well as other third-party collaborations.
• Assess whether data reported in support of registration for pharmaceutical products were generated according to applicable international / national regulations and the required corporate policies and procedures.
• Communicate any potential gaps to senior management in a timely manner.
• Based on review of audit findings or trends, highlight key areas for improvement within Clinical Development, Regulatory, Safety/Pharmacovigilance and Product Quality, with appropriate escalation of issues.
• Verify that work performed by vendors complies with Lilly and external regulatory quality requirements.
• Through engagement with pharmaceutical company peers and agency staff, seek to understand the changing regulatory environment, and proactively adapt work and company policies and procedures to align with regulatory expectations.

Business

Manage and provide leadership to a global staff of quality auditors in support of the implementation of the GQA audit program, objectives, and business operations. Participate in component-wide QA strategic planning meetings. Define strategy and action plans to continue to strengthen our GQA organization supporting Lilly’s corporate goals and objectives. Understand and extensively network with the LRL functional business area management to evaluate the impact of the quality strategy and seek synergies in our operations. Participate actively as a member of the GQA lead team in making and supporting key decisions and providing input to the strategic direction for the component. Participate in business planning process for GQA. Manage budget and headcount to meet targets.

People

Continuously assess business needs and allocate people and finances in a manner that efficiently utilizes and grows talent/expertise and balances audit demands versus GQA capacity. Ensure that sufficient technical resources are available, and the optimal organization exists, through a combination of education, experience and training to execute the audit plans and provide adequate support to the relevant business areas, quality and GQA. Partner with each Associate Director/Director, Sr. Director and other direct reports to ensure that challenging departmental and individual objectives are established and that all employees are following the global performance management processes. Partner with each manager and other direct reports to verify that all team members have a robust development and career plan. Provide timely feedback and coaching to aid in their development. Maintain appropriate knowledge and experience of quality assurance and technical expertise to facilitate necessary strategy development and decision-making.

Basic Qualifications

• Education: Bachelor’s Degree or equivalent in a scientific or health-related field.
• Experience: Minimum of five (5) years relevant industry experience in quality, clinical development, safety or regulatory affairs.
• Prior line management experience.

Additional Skills/ Preferences

• Advanced degree (Masters, 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.
• A 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, with proven ability to remain constructive and influential with peers, management and senior leadership, even in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• Work independently as well as collaboratively within a global team environment.
• Good analytical/problem-solving skills.

Additional Information

Located at Lilly Corporate Center. Occasional domestic and international travel, sometimes on short notice. Travel Percentage 0-10%.

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. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $163,500 - $239,800 Full-time equivalent employees also will be eligible for a company bonus (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 (e.g., 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 (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe! #WeAreLilly