All Of Our Groups

Healthcare

SiteComplianceLeader

$123–180k Houston, Texas, United States FULL TIME
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“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.

Healthcare
Problems you'll solve

Problem-solving skills

Eligibility Requirements

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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