Associate Director - Quality Engineering

BioSpace; Durham (NC); On-site; USD 118,500 - 173,800; Full time

Benefits offered by this job

Comprehensive benefit program

401(k) and pension plans

Health, dental, and vision benefits

Job summary

A global healthcare leader is seeking an Associate Director - Quality Engineering in Durham, NC. This role involves leading a team to ensure GMP compliance and quality oversight in the design and qualification processes. The ideal candidate will have extensive experience in quality engineering and leading teams to achieve high standards in a regulated environment. Excellent communication and leadership skills are essential for success in this position.

Qualifications

• At least 7 years of quality experience in related fields.
• Previous experience with C&Q / Verification and Validation oversight.
• Ability to work in a cross-functional team.

Responsibilities

• Lead a team of Quality Engineers for cGMP compliance.
• Provide quality oversight for verification and qualification processes.
• Support project initiatives in the Quality function.

Skills

Quality knowledge and expertise in parenteral

Leadership capability

Communication skills

Education

Bachelor's degree in a science, engineering, or related field

Tools

Microsoft Office

Trackwise

Job description

Associate Director - Quality Engineering

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Associate Director - Quality Engineering

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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.

The Associate Director - Quality Engineering is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge to lead the Quality Engineering team to provide guidance, consultation and oversight of the design, verification, startup, and ongoing life cycle management of the site facilities, utilities, and equipment. The position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, start up, and life cycle maintenance of site assets, utilities and processes, maintain external linkages and support preparation for pre-approval and general inspections by regulatory agencies.

Key Objectives/Deliverables

• Lead a team of experienced Quality Engineers in providing cGMP and Lilly Global Quality Standard expertise working with Global Facility Delivery team, site engineering team, Lilly site staff, and selected A&E firm to support the verification and qualification of site facilities, utilities, and equipment, employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design.
• Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.
• Consult with Network and Global quality groups including the Global Quality Systems, Engineering Technical Center, Global Parenteral Program, Pharmaceutical Delivery Systems, Global Packaging and Sterility Assurance Hub as required to ensure site team provides consistent and compliant approach is executed through start up and go-live phase.
• Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
• Provide quality oversight for the verification and qualification of the parenteral building, including review of test cases, test execution, discrepancy resolution, etc.
• Lead team in providing continued engineering oversite for post project work including:
• Ongoing equipment life cycle equipment changes, upgrades, improvements conducted during shutdowns.
• Site local capital project implementation support.
• Future global capital projects at the site.
• Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation.
• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality Engineering, site quality team, project team, and area process teams, including mentoring of new Quality and other project staff.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Support the definition and execution of inspection readiness activities as it relates to facility, utilities, equipment, and maintenance.
• Lead project initiatives needed in support of the project and Quality function.
• Resolve or escalate any compliance issues to the project, site, and Quality Management.
  
  
  

Minimum Requirements

• Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study
• At least 7 years of quality knowledge and expertise in parenteral, clean utilities, and / or device and packaging manufacturing.
  
  
  

Additional Preferences

• Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
• Previous experience with capital project delivery.
• Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of facilities, utilities, and equipment.
• Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
• Demonstrated Leadership capability leading a team.
• Proficiency with computer systems including Microsoft office products, Trackwise, etc.
• Responsible for maintaining a safe work environment, working safely & accountable for supporting all HSE Corporate, Project, and Site Goals
• ASQ Certified
• CSQA experience.
• Previous leadership of quality or technical teams
• Previous experience with device and packaging systems
• Previous experience with barrier or isolator technologies
• Previous experience with Manufacturing Execution Systems.
• Previous experience with global parenteral platforms (Cartridge, Syringe, or Vial)
• Previous use of KNEAT – or other electronic validation software.
• Previous computer system oversight.
• Strong technical aptitude and ability to train and mentor others.
  
  
  

Other Information

• Ability to work 8 hour days – Monday through Friday
• Ability to work overtime as required.
  
  
  

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$118,500 - $173,800

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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