Sr. Director - GMQO - Regulatory & Safety

Lilly • Indianapolis, IN

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About The Position

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 their 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.
Purpose:
The Sr. Director of the Global Medicines Quality Organization for Regulatory and Safety is responsible for providing leadership to guide and execute integrated quality systems to ensure integrity and patient safety across development business partners, including Regulatory Affairs (GRA), Global Patient Safety (GPS), as well as other organizations such as Health Economics and Outcomes Research (HEOR), Global Scientific Communications (GSC), and related functions. This includes overseeing the implementation of quality systems and managing audit and inspection activities to maintain sustainable compliance and drive continuous improvement and champions a culture of quality and compliance. The role will collaborate across R&D Quality functions to define and deliver GMQO strategies. The Sr. Director will work effectively with business leaders in Lilly Research Laboratories (LRL) in particular GPS, GRA and related organizations and other development functions (e.g., Clinical Development Operations, Global Quality Auditing and Compliance, Legal, IT, etc.).
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.

Requirements

• Bachelor’s Degree in a clinical or science-related field.
• A minimum of 10 years of industry related experience in quality, product safety, regulatory or equivalent with demonstrated understanding and application of quality management systems preferred or demonstrated equivalence.
• Knowledge of industry practices and applicable quality standards and regulations
• Experience managing regulatory inspections or audits
• Strong problem solving and decision-making skills, including ability to assess and manage risk appropriately
• Demonstrated leadership skills, including ability to develop and lead a team to deliver results
• Ability to collaborate with internal business partners and achieve results through them
• Strong teamwork and communication skills

Nice To Haves

• Prefer higher level degree such as Masters, PhD, PharmD or MD

Responsibilities

• Ensure a sustainable, technically capable organization for executing quality systems in Regulatory, Patient Safety, and other functions such as HEOR, GSC etc.
• Build organizational capabilities to meet future needs and the GMQO strategy through effective recruiting, training, coaching, and development of personnel.
• Maintain an optimal organizational structure to achieve objectives efficiently and effectively.
• Foster desired behaviors of teamwork, rapid technology adoption, continuous improvement and acceleration across the team and elevating performance for across the GMQO. Lead by example partnering effectively with peer leaders across the GMQO.
• Simplify and prioritize work to enable timely and effective decision-making.
• Partner effectively with leadership across GRA, GPS, and related functions to build strategies, align roles, responsibilities, and accountabilities, ensuring sustainable compliance and continuous improvement.
• Oversee the ongoing execution of quality systems ensuring data integrity and ensure patient safety for GRA, GPS, and related function activities at Lilly and third parties; assume leadership roles in cross-functional settings.
• Ensure strong quality interactions with Business Alliance partners to resolve issues, audits, and inspections.
• Understand the responsibilities of the EU Pharmacovigilance Qualified Person and ensure appropriate partnership to fulfill legal obligations.
• Represent Quality at key internal and external meetings, taking accountability for decisions while continuously seeking opportunities to learn from the external environment and improve processes.
• Contribute to the GMQO strategic initiative development and execution and deliver exceptional results.
• Drive issue resolution for Regulatory, Safety, and business partner matters that could impact compliance or quality; escalate appropriately to senior GMQO management and ensure timely notifications.
• Collaborate with other Quality groups to develop cross-functional processes and initiatives and resolve cross-functional issues promptly.
• Ensure consistent inspection readiness across the organization.
• Establish processes for managing internal/external audits and inspections, including those conducted by regulatory agencies and Business Alliance partners.
• Attract and continuously develop a high performing team with strong quality and business expertise, fostering a culture of learning and adaptability to new technologies, while leading audits and inspections, managing quality systems, and driving innovative solutions to resolve complex issues.
• Lead front-room and back-room activities during regulatory inspections and complex audits.
• Partner with GQAAC to establish and execute an annual internal audit plan.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• In addition, Lilly offers a comprehensive benefit program to eligible employees, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees