India Job Openings

Lilly
Associate Director - Operations - Device Assembly and Packaging
Indianapolis
FULL TIME
September 25, 2024
Key Objectives/Deliverables:
Strategic Planning: Engage and support business plan objectives while tracking team performance and ensuring adequate resources are in place for successful implementation.
Safety and Quality Culture: Lead by example in building and driving a culture of safety first and quality always within the organization while removing barriers to team performance. Review and approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.
Process Optimization: Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
Resource Management: Manage resources effectively, including workload optimization and staffing needs, to meet business objectives. Support Site Leadership to build a diverse and capable organization, supporting the areas of device assembly and packaging,
Collaborative Leadership: Collaborate closely with cross-functional teams, external partners, central functional organizations, and suppliers to drive alignment and resolve escalated issues. Represent the team on plant flow teams, influencing technical agendas and driving operational results.
Performance Metrics: Develop and communicate department metrics to drive continuous improvement and ensure alignment with business goals Develop team goals for safety, quality, and process effectiveness and efficiency.
Innovation and Problem-Solving: Foster a culture of innovation and creativity, encouraging team members to identify and drive improvement opportunities. This position may deliver equipment, lines, and supporting systems through technology transfers or process validations.
Regulatory Compliance: Ensure adherence to current regulatory requirements, including c GMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
- Bachelor's Degree in Engineering, Science, or a related field.
- 5+ years of manufacturing experience, pharmaceutical or regulated industry
- 3+ years demonstrated leadership skills with a history of successful team development.
- Excellent interpersonal, written, and oral communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization for decisions, influencing, coaching and mentoring.
- Knowledge of c GMP requirements in medical device manufacturing
- Responsible for maintaining a safe work environment and supporting all health, safety, and environmental goals.
- Understanding of basic requirements of regulatory agencies such as the FDA, DEKRA, and OSHA.
- Experience in device assembly and/or packaging.
- Occasional travel may be required to support business needs.
- PPE is required on the manufacturing floor.
- Previous equipment qualification and process validation experience
- Previous experience with deviation and change management systems including Trackwise
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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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