Director of Strategic Accounts
Airgas
Director – Global Process Owner, Sterility Assurance QMS
Eli Lilly and Company
full-time
Posted on:
Location Type: Office
Location: North Carolina, Wisconsin • 🇺🇸 United States
Visit company websiteSalary
💰 $151,500 - $264,000 per year
Job Level
Senior
About the role
- Establish and maintain the global quality system for Aseptic Processing Programs to drive standardization globally.
- Own the Global Standards, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
- Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
- Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
- Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
- Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
- Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
- Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
- Actively collaborate with enterprise-wide teams on standardized global business processes.
- As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
- Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Aseptic Processing requirements inclusive of Aseptic Process Simulations, Aseptic Technique and Barrier system (e.g. Isolators/RABs) management.
- Provide overall guidance and leadership as related to Aseptic Process Simulation Program Design and Implementation, Aseptic Controls and Practices including Cleaning & Disinfection, Barrier System Controls, and Aseptic Technique.
Requirements
- 10+ years’ experience in the pharmaceutical industry in roles across commercial manufacturing and or quality in a manufacturing, validation, and/or Quality roles supporting aseptic product manufacturing
- 7+ years’ experience in parenteral manufacturing sterility assurance control systems – development of systems, execution and operation of systems and continuous improvement of systems in a highly regulated environment
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
- Candidate will have previous experience implementing and leading global Sterility Assurance programs which can include Aseptic Training, Aseptic Process Simulations, and Isolator Controls and Management.
- Strong technical understanding of sterility assurance, from a science and compliance perspective.
- Current in technological and compliance developments across the parenteral manufacturing industry (e.g. filling technology, contamination control, Annex 1 interpretation)
- Strong written and oral communication skills.
- Understanding of cGMP’s, policies, procedures, and guidelines relating to sterility assurance
- Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate Goals.
- Approximately 25% travel.
Benefits
- Health insurance
- 401(k) matching
- Pension
- Vacation benefits
- Eligibility for medical, dental, vision and prescription drug benefits
- Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
Aseptic ProcessingSterility AssuranceAseptic TechniqueAseptic Process SimulationsBarrier System ManagementCleaning & DisinfectionPerformance MetricsRegulatory ComplianceContinuous ImprovementQuality Systems
Soft skills
LeadershipMentoringCollaborationCommunicationGovernanceAnalytical SkillsDecision MakingCommunity BuildingInfluencingProblem Solving
