Senior Director - Drug Product External Manufacturing - Quality Assurance

Company: Initial Therapeutics, Inc.
Location: Indianapolis
Posted on: January 21, 2025

Job Description:

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.Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200.Responsibilities:The Senior Director, Drug Product External Manufacturing (DPEM) - Quality Assurance (QA), provides leadership of the group accountable for all quality activities related to the oversight of North, Latin and South American contract manufacturers (CMs). This includes management of the supporting quality management system and oversight of the final quality of the products released to the market.Key Objectives / Deliverables:Quality Execution, Monitoring & Continuous Improvement:

• Ensure DPEM and CM compliance with Good Manufacturing Practices (cGMPs) and Quality Standards, including validation, change control, deviations, complaints, APRs, Quality plan, Self-Assessment, Quality agreement, good documentation practices and SOPs.
• Establish and maintain relationships with third parties and alliance partners to influence execution of regulatory requirements and Lilly quality systems.
• Ensure that an effective quality governance process exists to oversee external manufacturers. This may be different depending on the scope, complexity, and risk at a specific manufacturer.
• Establish metrics, collect, and analyze data, and actively monitor CM performance trends to identify potential safety and quality risks.
• Ensure inspection readiness at all times by coordinating internal and external audits; providing support to CMs as needed.
• Make decisions regarding the quality of batches; resolution of quality issues (approval/rejection/rework/refinishing), quality of partners (recommendation of approval or rejection).
• As Management Representative per 21 CFR 820.20, ensure the quality systems requirements are effectively established, maintained, and communicated; and ensure reporting on the performance of the quality systems to management with executive responsibility.
• Advise, support and influence decisions relating to new business development deals to ensure quality matters are appropriately considered.
• Be an active member of the DPEM Lead team, involved in leading the team, driving excellence and continuous improvement.
• Develop the functional Business plan and participate in the DPEM BP consolidation. Ensure the BP implementation within the established targets.Leadership / Supervision:
  • Allocate resources and ensure systems are in place to appropriately oversee and support, external partnerships and associated activities are conducted in a timely fashion and adhere to quality standards.
  • Ensure the organization has the necessary capabilities to fulfill its mission, periodically assess gaps and establish plans to close them.
  • Ensure employees have clear, actionable, and measurable objectives in alignment with the DPEM BP and functional objectives and with the Team Lilly expectations. Oversee the performance management and provide timely feedback.
  • Define development plans for each direct report and periodically discuss progress. Discuss career goals with each individual and establish career plans. Provide coaching based on individual needs. Continuously evaluate, train, mentor and coach personnel focusing on succession planning and ongoing performance improvement.
  • Support the team in minimizing risks and dealing with any concerns or issues effectively.Basic Qualifications:
    • Bachelor's or advanced degree in a science related field such as Engineering, Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
    • Minimum of 10 years' experience in drug product pharmaceutical manufacturing including commercialization of new products, with at least 5 years of experience in Quality roles.
    • Must have technical understanding and demonstrated application of cGMPs and Global Quality Standards to parenteral manufacturing, drug/device combination products, and packaging.
    • Management experience, inclusive of administrative responsibilities (e.g., resource and budget management) and coaching/developing personnel.Additional Skills / Preferences:
      • Strong leadership, cross-functional teamwork, and ability to influence internal and external stakeholders globally.
      • Experience in developing quality management plans, systems, and strategies in compliance with international regulations and industry standards.
      • Experience in oversight of third parties, including establishment and management of Quality Agreements and quality performance indicators, and strategic partnership in management of issues.
      • Good written and oral communication and critical decision making/problem-solving skills.
      • Experience in direct interactions with U.S. and international regulatory authorities.
      • Demonstrated ability to develop and successfully implement strategies for process optimization initiatives.Additional Information:
        • Position is located in Indianapolis, Indiana, USA.
        • Shift is days, but off-hours may be necessary to support operations.
        • Periodic travel, up to 30%.
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Keywords: Initial Therapeutics, Inc., Middletown , Senior Director - Drug Product External Manufacturing - Quality Assurance, Executive , Indianapolis, Ohio