Sr Director - Medicines Quality Organization, Cell And Gene Therapy

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Purpose:

The purpose of Sr Director – Medicines Quality Organization (MQO) is for the design, implementation, and execution of a medical, regulatory, and safety quality system to support the evolving Cell and Gene Therapy landscape.  This role is responsible for quality assurance, quality risk assessment and mitigation, continual quality improvement, assessment and implementation of external regulations and inspection readiness. The Sr Director will manage extensive interfaces with the cell & Gene Therapy discovery & research organizations across rapidly expanding product development and manufacturing capabilities and sites as well as corporate quality teams. This Sr Director will operate across many corporate functions including Global Patient Safety (GPS), Global Regulatory Affairs (GRA), Clinical Design, Delivery and Analytics (CDDA), Manufacturing, MQO, Global Quality Assurance Auditing & Compliance, Legal, and Ethics and Compliance; and third-party organizations (TPOs).  The Sr Director will seek to understand and define the Medicines Quality landscape across this rapidly expanding area. 

Quality Leadership

• The Sr Director is responsible for partnering with Cell & Gene Therapy Senior Management within discovery, research, product development and manufacturing as well as Medical, GRA, GPS, Data Sciences and Clinical Development on cell & Gene Therapy related matters to establish and sustain a “Quality in Design” approach to discovery research, product development, registration, and maintenance. This work will include partnering with wholly owned subsidiaries of Lilly.
• The Sr Director will design and lead the implementation of the SEQS Quality System to support cell & Gene Therapy across Medical, Regulatory and Safety and ensure operation in a manner such that all GCP/GVP activities are followed. 
• The Sr Director is responsible to engage externally to monitor, benchmark, and gather innovative intelligence to influence internally and externally quality related topics related to Gene Therapy.  
• The Sr Director is responsible for understanding and interpreting cell & Gene Therapy global regulations, requirements, and guidance as it evolves to ensure ongoing SEQS Quality System compliance.
• The Sr Director is responsible for ensuring development of quality education programs to support cross-functional integration, adoption, and utilization of the Cell and Gene Therapy expectations into the business.
• The Sr Director is responsible to partner with key stakeholders to influence the application of cell & Gene Therapy requirements across applicable functional areas and quality systems.    
• The Sr Director will partner with other members of MQO, Legal, and Ethics and Compliance to ensure alignment with Lilly Policies and evolving operational and quality strategies and initiatives.
• The Sr Director is responsible for providing quality leadership for the cell & Gene Therapy portfolio and partnering with Medical and Clinical Development functions in establishing appropriate support and oversight for each clinical development program, including sharing feedback for continuous improvement.
• The Sr Director is to ensure that Cell & Gene Quality and Clinical Development functions work in unison to ensure patient safety, data integrity and regulatory compliance.
• The Sr Director will establish relationships and partner with other Quality units (for example, Product Development and Manufacturing) to ensure seamless transitions of information and data where quality systems intersect.
• The Sr Director is responsible for establishing the appropriate level of quality integration with acquired Gene Therapy assets and wholly owned subsidiaries, supporting ongoing relationships.

Quality Risk Assessment, Mitigation, and Improvement

• The Sr Director is responsible for the effective partnership between Medical/Clinical and Quality personnel to identify and mitigate performance gaps relative to Quality requirements and to evolve the overall Quality understanding of cell & Gene Therapy requirements.
• The Sr Director is expected to actively participate in forums to assure quality plans/goals/initiatives are identified and implemented, and to identify areas for further improvement.

Inspection/Audit Readiness and Management

• The Sr Director ensures the necessary processes are being effectively implemented to prepare for and manage regulatory inspections, internal audits and third-party audits and responses to such activities.

Staffing Management

• The Sr Director will partner with the MQO Systems leadership to determine appropriate resources and for recruiting, hiring, and potentially supervising the necessary Quality resources to fulfill the Quality needs of the growing cell & Gene Therapy portfolio.

Minimum Qualification Requirements:

• Bachelor’s degree in a relevant scientific or clinically related field or demonstrated equivalent.
• A minimum of 7 years of direct experience with GCP regulations, Quality systems, Quality issue resolution, and/or regulatory inspections
  • Or A minimum of 7 years of experience in clinical development and/or related areas
  • Or A minimum of 7 years of experience in discovery/research technologies
• Ability to travel 15-30% of the time as needed

Additional Preferences:

• Higher Level qualifications are preferred (e.g., Masters, PhD)
• Excellent communication (written and verbal), interpersonal, organizational and negotiation skills.
• Strong knowledge of quality systems if no direct quality roles held.
• Demonstrated ability to supervise others.
• Demonstrated decision making skills.
• Demonstrated ability to operate across boundaries (cross-functional and cross-company) 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.

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