Associate Director-Quality Assurance

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Associate Director-Quality Assurance

Apply locations Ireland, Limerick time type Full time posted on Posted 2 Days Ago job requisition id R-57882 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 Title: Associate Director-Quality Assurance Reporting To: Senior Director-Quality Assurance Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. This is a unique opportunity to be a part of the leadership team for the startup of a greenfield manufacturing site, and the successful candidate will help to build the organization, the facility and the culture to enable a successful startup GMP manufacturing operations. Outline of Role: As members of the quality management team the Associate Director Quality Assurance is a key leader in the cross functional support of the manufacturing , warehouse and/or quality control operations. The Associate Director QA is responsible for QA business processes including support of GMP and GLP compliance, regulatory inspection readiness, Quality Plan and continuous improvement projects and will provide leadership and direction to the QA team across their area. Key Responsibilities:

• Be an active member of management team understanding the business and their role to ensure the business objectives are met
• Supervision and coaching of their QA team members including completing performance reviews and development planning, to ensure continued growth of technical depth and capability with the team.
• Manage training, qualification and performance of the team . Set job expectations and goals for individuals linked to team/site goals. Communicate appropriately with team members regarding site objectives and team business.
• Ensures that adequate resources are in place to support operations, new product introductions, batch disposition and quality system activities and productivity/continuous improvement initiatives in their area of responsibility.
• Review and approve specific quality documents consistent with procedural requirements; including, but not limited to, deviations, change controls, procedures, annual product reviews and validation documentation.
• Responsible for the escalation of critical quality issues as appropriate to Quality Management consistent with site procedure on Notification to Management.
• Provides technical leadership and advice for key Quality issues.
• Identify, prioritise, and support the implementation of continuous improvement initiatives, to maintain compliance while striving to meet business and customer needs.
• Maintain a continued state of cGMP compliance and readiness for Pre-Approval Inspections (PAIs) and Routine GMP Inspections by regulatory agencies.
• Promote continued alignment in Quality assurance business processes in Limerick and across the wider Lilly network.

Specifically, during the startup phase of the Limerick site (2023 to 2025) this role will be expected to b e a collaborative, inclusive, energetic leader and support the broader Limerick team to:

• Build the organization with the necessary capability, capacity and culture to operate this facility to the highest standards of excellence
• Develop and implement the systems and processed needed to run the site, leveraging existing Lilly knowledge and practices where necessary, but also incorporating external experiences and learning.
• Ensure regulatory compliance and operational excellence by supporting lean principles and a Digitally Native approach.
• Support the project team as they deliver the facility to the site team, by providing feedback and support on decisions & strategies etc. Collaborate with them to ensure the right decisions are made to meet project deliverables and longer-term strategic goals for the site.

Pre Requisites

• Proven capability within a GMP Manufacturing environment.
• Previous leadership experience through existing or previous roles.

Educational/Experience Requirements

• Bachelor of Science, Engineering, QP or equivalent Quality Management Qualifications
• Preferred > 6 years GMP Manufacturing experience and at least 1 year experience in leading a manufacturing support team in a Pharmaceutical/Bio-pharmaceutical setting.

Additional Skills/Preferences:

• Strong written and oral communication skills
• Ability to work independently, self-sufficiently and pro-actively in the performance of work duties.
• Ability to resolve conflict, and promote good decision making among team members

Key Attributes : (These will be what are used to assess the candidates) Business Knowledge :  High performance in delivery of their work. Looks at better, simpler ways , takes initiative and will run proactively with actions. Demonstrated self-management, prioritisation and organisational skills. Learning agility and Curiosity :  High learning agility and flexibility and ability to deal with ambiguity and uncertainty. Demonstrated ability to identify and prioritize problems, develop and implement solutions. Positive Influence : Demonstrated ability to address issues as they arise and take action. Trusted in the team to follow through on actions. Is interested in own performance and seeks feedback to improve. Relationship Builder : Demonstrated ability to establish and maintain key relationships across all levels in the organisation. Ability to lead people : Demonstrated ability to lead and motivate in a team environment. Demonstrated ability to influence peers and across functions. Communication : Demonstrated strong communication skills, written and oral in 1:1 and group situations. Decision Making : Demonstrated ability to be decisive and make well informed decisions for the benefit of the team. Demonstrated ability to collate required information and ask the appropriate questions of peers to get to the best solution. Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response. Lilly 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. #WeAreLilly

About Us

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world.How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!#J-18808-Ljbffr