Associate Director, Supplier Quality Management

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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.

The Associate Director, Supplier Quality Management, Avid leads quality oversight of a global supplier program supporting the manufacture of PET drug radiopharmaceuticals.

The individual is responsible for fulfilling the quality oversight and management of suppliers and service providers involved with the manufacture of components, materials, custom materials, starting materials, warehousing, and logistical services.

The position works closely and collaborates with Supply Chain, Global Investigational Product and Commercial Quality Assurance, CMC functional teams and Contract Manufacturers to ensure qualification and management of suppliers and service providers providing both custom and off the shelf materials utilized in the manufacture of PET drug product.

This role establishes and maintains standard operating procedures in alignment with corporate quality standards and current GMP expectations.

In collaboration with QA management, this position provides strategies, and solutions to achieve these responsibilities, improve the local quality system, and identify workstream efficiencies.

Key Objectives / Deliverables :

• Leads the identification, qualification and quality oversight of GMP suppliers and service providers
• Designs and contributes to the design of the risk-based supplier quality management program and leads efforts for periodic review and updates of established procedures in alignment with Lilly quality standards
• Manages established supplier reporting systems and prepares supplier performance metrics and risk determination in alignment with Lilly global standards
• Connects and communicates with suppliers to acquire supply chain and quality information
• Collaborates with associated Avid / Lilly team members and external contract manufacturing partners to ensure supplier problem resolution
• Develops content and ensures execution and maintenance of supplier quality agreements
• Coordinates the scheduling of supplier audits with corporate quality team members and serves as an audit team member, as required
• Leads management and evaluation program for supplier change notifications and complaint / corrective actions
• Accountable for the Manufacturing Materials Review Board for supplier performance
• Supports and contributes to drug product annual product reviews
• Manages review and release of packaged intermediate and reference standard materials
• Educates and mentors team members on quality requirements and supplier management

Basic Requirements :

Bachelor’s degree or advanced degree (i.e., Masters, PhD ), in a scientific discipline relevant to drug discovery, development, pharmacy, biology, or chemistry and a minimum 10+ years’ experience in pharmaceutical or medical device manufacturing Quality Assurance with at least 3 of the years’ relevant to parenteral product production and / or device manufacturing

Additional Skills / Preferences :

• Strong knowledge of commercial and investigational drug product supplier quality management
• Thorough knowledge of applicable regulations, such as global GMP regulations : US, EU, Japan, ICH Q7 along with IPEC and ISO standards and the ability to interpret and apply them.
• Experience writing and revising Quality Agreements
• Experience in leading risk evaluations and risk management
• Proficient in root causes analysis, review and approval of deviations / investigations, quality assessment of CAPA Plans and change controls
• Ability to simplify complex processes / problems and propose alternate solutions
• Quality oversight experience with third party / contract manufacturing
• Demonstrated negotiation and influence skills
• Demonstrated written, and interpersonal communication, and project management skills
• Knowledge of PET radiopharmaceutical manufacturing GMP’s
• Able to communicate effectively in both written and verbal forms to both internal and external customers

Additional Information :

• Ability to travel domestically and internationally from 10-25%, as required
• Preferred location Indianapolis or Philadelphia and remote will be considered
• Lilly currently anticipates that the base salary for this position could range from between $122,250 to $179,300 and will depend, in part, on the successful candidate’s qualifications for the role, including education and experience.

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).Of course, the compensation described above is subject to change and could be higher or lower than the range described above.

Further, 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.

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