Associate Director Quality Systems

Eli Lilly and Company; Richmond (VA); On-site; USD 123,000 - 180,400; Full time

Benefits offered by this job

401(k) plan

Pension program

Medical, dental, vision benefits

Vacation and paid time off

Job summary

Eli Lilly and Company is building a cutting-edge biotech drug substance manufacturing facility in Richmond, VA. The Associate Director Quality Systems provides quality leadership, governance, and cross-functional guidance to ensure GMP compliance and continuous improvement.

The role focuses on Quality systems, vendor management, document control, and E-systems; travel is 0-20% and requires strong problem-solving and regulatory knowledge.

Qualifications

• BS in Pharmacy, Science, Engineering or related discipline is required.
• Minimum of 8 years of experience in quality assurance within a manufacturing environment.
• Minimum of 4 years leadership experience with direct reports.
• Strong knowledge of cGMP, FDA, EMA, Data Integrity and Quality Risk Management.

Responsibilities

• Provide quality leadership, direction and governance for Quality systems and compliance at the Richmond site.
• Escalate critical quality issues to line management and QA leadership as appropriate.
• Review and approve quality documents including vendor management and change controls.
• Lead improvements within quality systems and supervise QA teams and document control.

Skills

Quality leadership

GMP knowledge

FDA/EMA regulatory knowledge

Data integrity

Problem solving

Communication & teamwork

Education

BS in Pharmacy, Science, Engineering or related discipline

Tools

TrackWise

Kneat

DCS

DeltaV

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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.

Minimum Qualifications

• 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.
• Quality Systems experience is a must.
• Excellent problem-solving and analytical skills.
• Detail-oriented with a strong commitment to maintaining high-quality standards.
• Effective communication and teamwork skills.
• Demonstrated initiative - able to work proactively without direct supervision and with a continuous improvement mind-set.
• Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., Kneat, DCS, DeltaV) is a plus.

Additional Requirements/Information

• Travel: 0-20% in the beginning.
• Intra-Site travel required.
• The individual must work with a wide variety of people both internal and external to the Quality Unit.
• Ability to field incoming requests in a timely, appropriate manner.
• Processes are continually being improved and a willingness to implement change is important.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$123,000 - $180,400

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). 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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