M&Q Sr. Director Digital Quality Assurance systems and Technical Services/Manufacturing Sciences, Tech at Lilly MQ
Eli Lilly
- Indianapolis, IN
- Permanent
- Full-time
- Be Bold - We are looking for a leaders at all levels to tackle tough challenges and ability to coach through translation of complex business requirements into robust business process and data solutions.
- Be Fast - We need someone who is willing to move at the pace of MQ and the Growth of the organization.
- Be Engaging - We need a leader who will engage a broad and diverse team focused on re-imagining Quality and Manufacturing processes using automated solutions, bring new capabilities such as Artificial Intelligence, next generation platforms using modern API’s and tech stack.
- Must have a strong understanding of corporate computer system validation requirements according to Lilly Quality Standards, providing technical guidance to the global and site teams ensuring quality of operations and deliverables.
- Must have a combination of technical and soft skills to effectively collaborate with cross-functional teams and drive continuous improvement with Quality and TSMS leaders.
- Must communicate technical information to non-technical stakeholders, influence decision making at all leadership levels, adept at networking and building strong professional relationships.
- Proactively monitor and stay abreast of evolving business and technology trends, in the realm of Digital quality, Manufacturing Control Strategies. Continuously seek out innovative approaches to enhance our processes.
- Experience with cGMP regulations, Data Integrity requirements in a highly regulated environment.
- Strong understanding of QMS business processes, Manufacturing, Development Technology Transfer process, Computer System Validation.
- Leverage an agile mindset and framework for the entire product lifecycle.
- Coach and mentor team members on best practices and standards.
- Experience with QMS processes, implementing enterprise Quality Management System.
- Experience with Good Manufacturing Practices with demonstrated experience in computer system validations efforts.
- Understanding of Complaints management, Deviation Management, CAPA, Change Management, Quality Risk Management etc.
- Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
- Experience working with modern technology stack including cloud-based solutions, Artificial Intelligence.
- Additional Experience in the following would be preferred but not required:
- Masters degree in computer science, Information Technology or related technical field.
- With a minimum of 7+ years in IT leadership roles, Quality and Manufacturing strategies driving strategic initiatives and fostering team growth.
- Must have relevant leadership experience leading, delivering and/or supporting enterprise IT platforms within a highly regulated industry
- Excel in negotiation, driving consensus across complex stakeholder groups to achieve desired business outcomes. Combine assertiveness with effective change management.
- Passion for working on a team from diverse backgrounds and geographies.
- Familiarity with Agile ways of working, Product framework