(Sr.) Quality Oversight And Capability (Qoc) Manager

3-4 years

Not Disclosed

Shanghai Shi

10 Jan. 30, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: (Sr.) Quality Oversight and Capability (QOC) Manager
Location: Shanghai, Shanghai, China
Category: Research & Development
Job Type: Full Time, Regular
Job Id: R-77886

Company Overview:

At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader headquartered in Indianapolis, Indiana, our employees across the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to communities through philanthropy and volunteerism. We are committed to making life better and looking for people determined to make an impact globally.

Purpose of the Role:

The (Sr.) Quality Oversight and Capability (QOC) Manager will provide support to staff engaged in clinical research at the country and site level, focusing on Clinical Operations deliverables. This role is designed to promote quality and compliant execution of clinical research while delivering high-quality data from sites in China. The position will provide practical tools, training, and consultation on internal business processes, enabling a seamless and efficient clinical operations environment.

Primary Responsibilities:

1. Develop and Maintain Oversight Processes for Clinical Operations Deliverables

Collaborate with cross-functional teams to identify and drive innovative solutions. Ensure consultation on the application of new technology and tools, enabling optimal use by investigative sites and patients.
Manage a quality improvement agenda based on internal and external trends. Lead oversight activities to ensure compliance with CDOS and relevant Lilly processes for China clinical operations.
Identify training needs for the organization based on business needs and trends, collaborating with subject matter experts to deliver regular training sessions on process updates and refreshers.
Network with cross-functional teams to onboard new service vendors and optimize the vendor onboarding process to accelerate contract execution with compliance.
Ensure system management capabilities within Clinical Operations functions, overseeing system implementation locally with global engagement.

2. Support Quality Activities for China Clinical Operations

Develop and maintain an external party management process for China, aligning with global Lilly requirements and local regulations.
Participate directly in quality planning activities with internal and external business partners. Interface with the quality function of any Third-Party Organizations (TPOs) used by China clinical operations.
Incorporate learnings from issue management, inspections, and audit findings to improve the quality of clinical research execution at the country level and investigator sites. Ensure effective CAPA (Corrective and Preventive Action) implementation through updates to working documents, forms, and templates.

3. Provide Expertise in Regulations and Compliance

Understand and comply with regulatory requirements, ICH/GCP guidelines, and applicable local regulations.
Ensure adherence to Ethics & Compliance, Procurement, Legal, Financial, and Global Medical Standards and Procedures.
Expertly apply regulations and guidelines regarding local study execution practices, including process maps, tools, and resource documents.

Minimum Qualifications:

Bachelor’s degree or equivalent experience in a scientific or health-related field.
A minimum of 3-5 years of CRA (Clinical Research Associate) experience or 2 years of experience as a Country Study Manager (or similar position) in clinical trials.
Fluent in English (reading, writing, and speaking).
Strong organizational and self-management skills.
Project management skills and ability to prioritize multiple tasks.
Strong problem-solving and communication skills (both verbal and written).
Proficiency in Microsoft Office software.
Flexibility to attend meetings with the global team outside of standard working hours.

Additional Preferences:

Strong analytical skills with proficiency in risk management and contingency planning.
Leadership skills with the ability to network effectively.
Strategic thinking, self-motivation, and strong teamwork spirit.

Equal Opportunity Employer:

Lilly is dedicated to helping individuals with disabilities engage in the workforce and ensures equal opportunities for all candidates. If you require accommodation to submit a resume, please complete the accommodation request form here. Please note this form is for accommodation requests only, and other inquiries will not receive a response.

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.

#WeAreLilly

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(Sr.) Quality Oversight And Capability (Qoc) Manager

Job Description

Company Overview:

Purpose of the Role:

Primary Responsibilities:

Minimum Qualifications:

Additional Preferences:

Equal Opportunity Employer:

#WeAreLilly

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