Associate Director, Quality Assurance - Compliance

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.

Ihre Aufgaben

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 - Compliance has the responsibility for ensuring that the quality management system is established and effective. The individual in this role promotes awareness of management system requirements throughout the organization. The Associate Director is also responsible for the staffing, training, and leadership of the site compliance group in the design and development of key site compliance systems and procedures to support the implementation of the overall site Quality Management System (QMS).,

• Supports the Site Compliance Leader in the development of the site the Quality Management System and execution of site Quality programs

• Ensures that quality system requirements are effectively established and effectively maintained in accordance with applicable regulatory requirements (e.g., EU Annex I, ISO13485)

• Leads reporting of the performance of the quality systems to site leadership and site flow/process team management

• Build a diverse and capable site compliance organization linked to the Lilly global organization in support of implementing and maintaining the site Quality Management Programs, systems, and procedures, including:

• Deviation Management

• Change Management

• CAPA Management

• Product Complaints

• Site Self-inspection

• Management Review

• GMP Library and Document Control

• QA for QC

• Fosters a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group

• Supervises, coaches, and aids in employee development and performance management

• Ensures a fair and equitable work environment

• Networks with global and other parenteral and device assembly sites to understand best practices, share knowledge, and participate in tactical and strategic business planning

• Works cross-functionally across all areas of the site for coordination, planning, and execution of activities

• Sets human resource and business plan goals

• Plans and supports execution of site regulatory agency inspections

• Assists the Site Compliance in coordination and execution of the site Quality Plan.

Ihr Profil

• Bachelor's degree in a science, engineering, or pharmaceutical-related field of study or equivalent experience.

• 3+ years in pharmaceutical leadership with specific Quality Management System 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, site compliance processes, and applicable regulatory requirements

• Previous parenteral manufacturing or device assembly experience

• Previous experience with pharmaceutical computer systems and applications including SAP, Veeva QDocs and TrackWise or similar systems

• 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,

• 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

Kontakt

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.