Sr. Director – Quality – Molecule API External Manufacturing

Key Responsibilities

• Leading the definition of the quality strategy and quality plans for the Small Molecule Plant and aligning with the Site Quality leaders from the Large Molecule and Peptide Plants as well as the broader External Manufacturing organization.
• Ensuring the Small Molecule Plant operates in accordance with the quality management system for API External Manufacturing.
• Ensuring staff are qualified and that the required training of all quality personnel is completed and adapted according to need.
• Ensuring robust control strategies are developed and maintained for the API EM Small Molecule portfolio of products.
• Ensuring robust batch release execution processes are in place and are being executed, including appropriate evaluation of batch production records.
• Ensuring appropriate oversight of Contract Manufacturers and Contract Laboratories supporting the Small Molecule portfolio for API EM and that our Contract Manufacturers and Contract Laboratories have effective quality systems in place.
• Supporting Inspection activities at our Contract Manufacturers and Contract Laboratories as required.
• Ensuring all required testing is carried out in a compliant manner, including setting of appropriate specifications, development of robust sampling processes and investigating any anomalies.
• Ensuring the effectiveness of the site’s quality system including execution of the site self-inspection program.
• Ensuring deviations, OOS and complaints are investigated and resolved.
• Ensuring appropriate stability data is available to support storage and retest or expiration dating periods.
• Participating in and approving annual product reviews.
• Notifying senior management of significant quality related issues.
• Ensuring the prompt closure of all regulatory commitments.

The site quality leader (Sr Director – Quality – Small Molecule API EM) is responsible for ensuring that products are manufactured and released in compliance with marketing authorization requirements and GMPs.

• Ensuring and monitoring compliance with local regulations and the requirements of GMPs.
• Authorizing written procedures and other key GMP documents.
• Participating in management reviews of process performance, product and data quality, and of the quality management system, and advocating continual improvement.
• Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
• Ensuring the adequacy and effectiveness of the personnel qualification and training program.
• Approving and monitoring suppliers of material (where owned by Lilly).
• Approving and monitoring contract manufacturers, GMP service providers, and consultants.
• Ensuring record retention processes are robust for the Small Molecule Plant.

• Serve as the Site Quality Leader for the Small Molecule EM Plant as a member of the Small Molecule API EM Plant Lead Team.
• Ensure site compliance to all cGMPs, procedures, standards, guidelines and regulatory commitments.
• Support quality related forums (e.g., Technical Review Boards) required to maintain compliance and continuous improvements.
• Ensure the creation and maintenance of a site Quality Plan and monitoring of metrics to deliver a complaint quality system.
• Coordinate and oversee regulatory inspections.
• Review and approve documents supporting manufacturing and quality systems (e.g., procedures, deviations, changes).
• Build strong relationships with peers in API EM management, as well as key internal customers/partners, and CM partners.
• Lead organizational and business planning for the Small Molecule Quality organization, aligning with the broader EM Quality organization as required to ensure there are adequate QA resources to support the business, and the plant continues to grow and prepare for the future needs.
• Lead the API EM Quality team, providing coaching/feedback to develop leaders and team members, including performance management, talent assessments, mentoring, succession planning, and organizational planning.
• Participate as a member of the External Manufacturing Quality…