Associate Director Quality Systems

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.

Lilly is building a next-generation biotech drug substance manufacturing facility in Richmond, VA-our most technically advanced site to date. This greenfield facility will feature cutting-edge manufacturing technologies and advanced data platforms designed to drive improvements in safety, quality, and productivity. This is a rare opportunity to shape an organization, a facility, and a culture from the ground up.

The Associate Director Quality Systems plays a critical role in providing Quality leadership, direction, and governance for Quality systems and compliance, within our manufacturing facility. You will work closely with cross-functional teams to Provide Quality system guidance.

Key Responsibilities

** _GMP Compliance:_*
* + Responsible for the escalation of critical quality issues as appropriate to line management and off-site Quality Assurance management consistent with the site procedure on Notification to Management

+ Responsible for review and approval of specific quality documents consistent with procedure requirements; including, but not limited to, documents associated with Vendor Management, Service Providers, Quality Systems such as Document Control

+ Responsible for review and approval of specific quality documents consistent with procedure requirements; including, but not limited to, deviations associated with QA e-systems, Quality Assurance procedures, change controls, etc.

** _Quality Systems and Customer Focus:_*
* + Responsible for implementing improvements within quality systems

+ Specific responsibility for supervision of Vendor management reps, QA E-Systems rep and Document Control

+ Involved with Vendor management reps, Doc. Control Management, QA E-Systems rep, QA Assistants, Site Self-Assessment and customers in improving the quality systems at the site.

+ Responsible for business processes or resolution of quality issues pertaining to E-Systems, vendor management.

** _Technical Excellence:_*
* + Provides the tools and resources to allow the QA systems and compliance unit to carry out their responsibilities.

+ Provides technical leadership and advice for key quality issues

+ Works with individual reports to develop & maintain their training, performance management plans, reviews & career plans; provides consensus feedback and helps manage assignments & workloads

** _Corporate/Site Strategy and Mission:_*
* + Supports the organisation through expense, capital, headcount, and project business planning and aligning with various sites and corporate business plans in respect of GMP and compliance requirements and standards.

+ Have responsibilities consistent with the responsibilities, summarised below:

** _Business Management Role_*
* + Developer of measures.

+ Improvement promoter.

+ Technical leader / guide

+ Decision maker

+ Event manager

+ Daily contact person / co-ordinator

** _People Management Role_*
* + Performance manager / improver / coach

+ Role model

+ Policy administrator / Decision maker

+ Team builder / motivator

+ Main link in the communications chain.

** _Site Management Role_*
* + Member of site management with shared responsibility for the site meeting its targets.

+ Focus on 1-2-year business planning and resource allocation.

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* Minimum Qualifications:

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* + BS in Pharmacy, Science, Engineering or related discipline.

+ Minimum of 8 years of experience in quality assurance within a relevant manufacturing environment.

+ Minimum of 4 years leadership experience with direct reports.

** Additional Skills/Preferences:*
* + Strong knowledge of cGMP, FDA, EMA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements.

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