Associate Director, Quality Assurance

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.

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.

**Position Overview**:
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance leaders to support our growth in Alzey, Germany. This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Associate Director, Quality Assurance (QA) - Materials, will lead the start-up and routine operation of the QA organization overseeing the Materials Management and Logistics operations at the Alzey site. Responsibilities include technical and administrative leadership, as well as project management.

**Responsibilities**:

- Serve as technical resource to review and approve materials management documents (e.g., qualification documents, change controls, procedures, quality agreements)
- Network with cross-functional resources to ensure establishment of the materials management quality system
- Facilitate project delivery through support of materials implementation associated with site expansion
- Work with the Site Quality Leader to support the development of the vision, strategy and quality culture for the overall site quality assurance organization with focus on materials management, supplier and service provider governance and logistics activities.
- Support initial recruiting, build capability, for a diverse quality assurance staff
- Support the site to ensure a safe work environment including supporting and leading safety efforts for your team
- Establish site material supplier program, partnering with other Lilly manufacturing sites and global materials management teams
- Build the team to develop and maintain the approved supplier list, Quality Agreements, material and supplier risk assessments, and periodic reviews of supplier performance
- Provide support to the warehouse and logistics for all operational quality assurance needs and materials approvals
- Responsible for materials and supplier complaint handling
- Support the development of the overall site operational readiness plan including development of quality processes and approval of operational procedures and controls
- Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group
- Supervise, coach, and aid in employee development and performance management; ensure a fair and equitable work environment
- Review and approve GMP documentation including procedures, deviations, technical reports, change controls, etc.
- Participate in tactical and strategic business planning

**Basic Requirements**:

- Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.
- 3+ years in pharmaceutical leadership with specific Materials QA experience, including leading or working effectively with a cross-functional group
- Fluent in English and German
- On-site presence required

**Additional Skills/Preferences**:

- Strong knowledge of Quality Management Systems and applicable regulatory requirements
- Previous materials management and supplier management experience
- Excellent interpersonal, written and oral communication skills
- Strong technical aptitude and ability to train and mentor others
- Demonstrated technical writing skills
- Demonstrated problem-solving and decision-making skills
- Previous facility or area start up experience
- Previous equipment qualification and process validation experience
- Previous regulatory inspection readiness and inspection execution experience

**Additional Information**:

- Flex hours possible
- Primary location is Alzey, Germany
- Ability to travel (approximately 10-20 %)
- Ability for Short Term Assignment (6-9 Months) in a Parenteral Products Network (PPN) established manufacturing site prior to starting the role

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