All Of Our Groups
Healthcare
SiteComplianceLeader
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Site Compliance Leader at All Of Our Groups. Skills: Compliance, Quality assurance, Regulatory affairs. Establish and document quality management system processes. Monitor and report on quality management system effectiveness”
Industry & Context.
Problem-solving skills
Travel 20%, Authorized to work in US
What They're Looking For.
Must Have
BSc, Hons BSc, MSc, or PhD, 12+ years of experience in quality assurance, Biotechnology or pharmaceutical manufacturing environment
Nice to Have
Follow-up skills
What You'll Do.
Establish and document quality management system processes
Monitor and report on quality management system effectiveness
Ensure awareness of regulatory requirements
Liaise with central groups on quality standards
Sponsor site quality initiatives
Support network quality initiatives
Create and manage Site Quality Plan
Manage Site Quality Manual
Govern key quality processes
Provide direction for quality governance boards
Ensure quality oversight for material management
Ensure quality oversight for supplier management
Ensure quality oversight for incoming controls
Ensure quality oversight for complaints
Lead quality culture behaviors
Coordinate regulatory inspections
Lead site inspection readiness program
Act as liaison with Regulatory for Site Licenses
Act as liaison with Regulatory for declarations
Act as liaison with Regulatory for Site Master
Act as liaison with Regulatory for other documents
Benchmark industry trends
Share industry trends with quality organizations
How You'll Work.
Team & Collaboration
Cross-functional teams; Central groups
Communication Scope
Written communication; Verbal communication
Full Job Description
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. ## The Site Compliance Leader plays a critical role in managing compliance to all regulatory requirements in line with Lilly Houston procedures, policies and guidelines for next generation biotech facilities. You will work closely with cross-functional teams by having oversight of central quality systems and processes. Provide quality and technical expertise within the quality department of Lilly Houston. ## ## **Key Responsibilities** ## · Ensure that processes needed for the Houston quality management system are established and documented. ## · Monitor and report on the effectiveness of the quality management system and needed improvements. ## · Ensure awareness of applicable regulatory requirements and quality management system requirements throughout the organization. ## · Liaise with and influence central groups on corporate quality standards and initiatives. ## · Sponsors site initiatives related to quality and compliance; supports network initiatives related to quality and compliance for local implementation; acts as connection for global initiatives related to quality and compliance for local implementation. ## · Ensure creation and manage Site Quality Plan and Site Quality Manual and ensure adequate governance of key quality processes at the site (e.g., site quality lead team, management reviews of quality systems, etc.). ## · Provide direction for the site-wide quality governance boards (e.g., site quality lead team,
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