Lilly Consultant-Medical Quality in Indianapolis, Indiana

42734BR

Responsibilities:

Purpose:

The purpose of the Consultant, MQO Corporate role is to be the quality expert for their given area of responsibility (regional/affiliate, portfolio and/or functional business units). The Consultant actively participates in strategic planning to strengthen the quality of Medical Research, Safety and Efficacy Quality System (SEQS) effectiveness, and the integration of quality into business processes. The Consultant is responsible for the implementation of quality initiatives and providing guidance to team

Primary Responsibilities:

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

  1. Functional and Technical Expertise
  • Familiar with regulations and guidelines: provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations

  • Provides guidance and expectations to the business to enable execution of regulations on a local, regional and global level ensuring compliance and inspection readiness

  • Provides key input into the design of SEQS and leads implementation into the business areaa

  • Participates in SEQS procedure development and in Change Control as appropriate

  • Provides input and feedback on quality standards and expectations. Is accountable for the implementation and delivery of milestones for the quality system

  • Accountable for the development and implementation of the quality strategy for the portfolio and functions, partners with business to complete quality risk assessments and develop a risk management plans

  • Performs on-going risk assessment and evaluation of the quality of medical research to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actions

  • Expert in corrective and preventative actions (CAPA) management. Supports/educates the business in developing robust CAPA and monitors through to resolution.

  • Expert in Deviation Management/Root Cause Investigation

  • Expert in audit and inspection response managment

  • Reports issues through Notification to Management (NTM) as appropriate

  • Evaluates and approves change management proposals to ensure changes are appropriately assessed, documented and valid. Provides input into Global Quality Auditing and Compliance (GQAAC) audit plans a based on identified signal/risks/gaps

  • Defines, executes and documents quality self assessments checks/self inspections throughout the clinical development process and discusses output with business partners

  • Supports Business Quality Assurance for critical business systems in area of responsibility (i.e. LEO, IMPACT)

  1. Inspection Readiness and Inspection Management
  • Leads pre-inspection preparation activities in collaboration with business partners

  • Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management

  • Actively supports site and sponsor inspections

  • Responsible for inspection response management and tracking through resolution

  • Coordinates audit responses including Trackwise system documentation

  • Functions as an expert in corrective and preventative actions (CAPA) management

  • Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections

  1. Quality Decision Making
  • Responsible for quality consultation across clinical research development (protocol to disclosure) involving interactions with all levels across the organizations, including groups such as Legal, Compliance, Finance, Medicines Development Unit (MDU) etc.

  • Consults on root cause analysis with internal and external business customers/partners to identify solutions and prevent issues that impact function or geography

  1. Influence Quality Direction
  • Leads the direction of quality for supported area/function and works with other consultants to ensure consistent practices are employed

  • Provides technical and team leadership for quality, portfolio, medical affairs, and divisional projects.Ability to engage and influence leadership across organizations(Legal, Compliance, Finance, MDU,, External Partners/Customers etc.) to resolve complex issues

  • Leads the team to deliver innovative solutions, preventing re-occurrence of issues

  • Utilizes quality experience to support change management and business transformation in the delivery of the portfolio

  1. Problem Solving
  • Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the resolution of issues. Escalates issues and manages the interfaces to ensure issues are resolved

  • Raises issues to management, including issues that could have the ability to impact the portfolio. Develops well thought out solutions and presents clear action plans

  1. Quality Technical Leadership
  • Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of the portfolio

  • Initiates, drives and coordinates quality improvement initiatives across affiliate, site(s) or functions

  • Key resource in the development of new business process and partnerships - developing quality agreements and directing management of key steps required to ensure quality, including evaluating (risk assessment or vendor assessment) the partnership (third party or alliance), the program and setting forth the quality direction and approving oversight plans

  • Leads the harmonization of best practices and projects across the regions, functions and other Quality organizations and recommends key projects

  1. Project Management
  • Engages and mobilizes cross functional and geographical work teams to deliver projects successfully - influences assignment of resources to enable project progress

  • Utilizes project planning and maximizes the use of the Six Sigma methodology to achieve project results. Builds innovative, simple and workable solutions to solve business problems

  1. Customer/External Focus
  • Sets the quality expectation for third party partners and advises on requirements and inspection needs

  • Acts as quality expert consultant to the business and external parties. Builds relationships with internal and external customers and partners

  • Leads the development of quality agreements internally and with external parties and alliances. Interacts with regulators, customers or other outside stakeholders on business issues

  • Manages audits and regulatory inspections in cross-functional company areas, across regions and with external partners

Req ID:

42734BR

Additional Skills/Preferences:

  • Global perspective and working across functional and geographical boundaries

  • Extensive knowledge of GxP regulations, guidelines and standards

  • Demonstrated understanding of quality management system principles, including policies, procedures and processes

  • Demonstrated ability to identify root cause and manage difficult global business/quality issues. Ability to separate critical from non-critical issues

  • Knowledge of the international regulatory framework

  • Ability to influence, negotiate and project manage

  • Ability to work effectively at all levels of the organization

  • Excellent problem solving skills and initiative

  • Proficient written and spoken English language skills

  • Effective verbal communication

Additional Information:

  • This role is located in Indianapolis

  • Lilly is an EEO/Affirmative Action Employer and 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.

Location Details:

Branchburg

Title:

Consultant-Medical Quality

Job Category:

Science

Basic Qualifications:

  • Bachelors Degree in a science, technology or medically-related field

  • At least 5 years experience in pharmaceutical research and/or quality

  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Company Overview:

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 39,000 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.

City:

Indianapolis

Country:

USA

State / Province:

Indiana

Region:

North America