Quality Assurance Manager, Product Quality

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 35,000 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.

Recognitions

We are excited to share that Lilly has been named the most innovative pharmaceutical company in the world! The IDEA Pharma 10th annual Pharmaceutical Innovation Index and Fortune Magazine ranks the industry’s best pipelines, evaluating novelty and meaningful development, across first in class development, breakthrough medicines and more, and Lilly took the TOP SPOT!

2021 Recognitions

• DiversityInc, Top 50 Companies for Diversity - No. 3
• Ethisphere, World's Most Ethical Companies
• Forbes, America’s Best Large Employers
• Fortune and IDEA Pharma, Pharmaceutical Innovation Index – No. 1
• Human Rights Campaign Foundation, Corporate Equality Index – Perfect Score

About Lilly Taiwan

Here at Lilly, we are focused on our common purpose to make life better for people around the world. Whether here in Taiwan, the greater NAPAC region, or our corporate headquarters in Indianapolis, each team member plays a critical role in ensuring we deliver on that purpose.

The Lilly Taiwan team is an exciting and fulfilling place, where we work hard to change lives for patients while supporting and encouraging each other to be and bring our best. Lilly is a place you can grow and lead, innovate, connect with coworkers who care about you and find meaning in the work you do. Join us.

Responsibility:

The purpose of Product Quality Representative (PQR) is to manage Quality Assurance of the Lilly pharmaceuticals in a Marketing Affiliate, and with three major objectives;

• Assist the Quality Management/ Regional Quality Leader and the Local Management in meeting global policies and local quality procedures that apply to the Marketing Affiliate.
• Ensure compliance with Good Manufacturing Practices (cGMP), Good Storage Practices (GSP), Good Distribution Practice (GDP) and others that apply to the operations of the local Subsidiary, as well as compliance with applicable local regulations.
• Responsible for properly handle Corporate Quality audits, inspections of local regulatory agency program and execute the annual Quality self-inspections.

And the responsibilities and duties may include but not limited to;

• Develop the annual quality plan and submit it to the Regional Quality Leader for review and approval. This should include audits of external party needed, especially those hired to storage services and distribution of products, self-assessments, and management of quality of local Affiliate.
• To be the primary contact in the Affiliate to any topic related to product quality.
• Report to the Regional Quality Leader any issue or failure of the local quality and scale to the Affiliate Management and Global Quality Leader in a timely manner when applicable.
• Prepare Notification to Management as applicable after consulting the Regional Quality Leader.
• Determine urgently the impact of quality issues or failures on products, with special attention to those that may impact the safety of patients or produce a recall.
• Immediately notify the Regional Quality Leader for subsequent elevation to the Global Quality Leader and Local Management.
• Ensure that all deviation occurred is properly reported, investigated and closed in accordance with standard procedure indicating the local operation by tracking system. Must ensure that the corresponding plan of corrective and preventive actions, involving relevant areas is established and completed on time.
• Release for sale just finished product batches that meet all quality specifications and local regulations.
• Any situation involving a deviation, release the batch of product for sale, only when the deviation report and their respective investigation indicating that the product meets the required quality specifications.
• Report immediately to the Regional Quality Leader suspected theft, tampering or other situations that could jeopardize any product quality, and its subsequent communication to Global Quality Leader and Local Management.
• Ensure that local customization is performed following the guidelines established by the quality area and according to global policies and standard operating procedures that apply local.
• Perform any relevant Quality Assessment to external party that could be hired by local Affiliate or can perform any GMP/GDP operation that could potentially impact product quality of Lilly products. Review the impact they might have on agreements between local affiliate and external parties, e.g.: distribution agreements on products and / or medical samples, Co-marketing agreements, copromotion agreements, divestments or Non-Trademark others. Follow the guidelines established in the LQS102 "Quality Management of Collaboration with External Parties"
• Prepare Quality Agreement to be signed between the external party and local affiliate; coordinate the process of signatures as well as the periodic review of the agreement as provided in the corresponding global standards.
• Monitor compliance with the external party on their standard operating procedures and Lilly when applicable. Report any deviations to the procedures to be detected.
• Especially those related to the receipt, handling, storage, delivery and distribution of Lilly products.
• Evaluate and approve (when required) those promotional materials that could potentially impact the Patient Safety and / or product quality.
• Ensure that the process of " Change Control " follows as indicated in the standard procedure for local operation and any proposed change (internal or external) that could potentially affect any of the product quality.
• Coordinate (ordinary or extraordinary) audits or visits, undertaking local regulatory agencies relating to GMP/GDP issues or quality management. Notify the Regional Quality Leader as soon as possible about the visit. Similarly, communicate the results of the inspection, with emphasis on cases investigated that has been conducted on samples or products, or has generated an observation or any situation that may represent a potential risk to the company.
• Receive and respond global quality audit report, after reviewed by Regional Quality Leader.
• Monitor and ensure timely Affiliate implement local action plans relating to GMPGDP issues or quality management of the affiliate. Agree on Regulatory Agency or Global Quality Audit inspection responses with RQL.
• Report, at least quarterly, the Regional Quality Leader the progress regarding the implementation of the action plans agreed to inspections of premises Regulatory Agencies (GMP aspects or quality management Affiliate) or global quality audit.
• Approve all quality documentation relating to GMP/GDP operations of local Affiliate.
• Conduct the training of Affiliate personnel including Country Manager and Sales Reps on GMP/GDP standards that apply to the Marketing Affiliate, following the guidelines of GQS181-Marketing Affiliates.
• To support training programs to external customers in areas such as cold chain management and handling of returns, among others, as needed.
• In situations of product Recall or withdrawal of marketed Lilly products, Product quality representative takes the role of Recall Coordinator for the affiliate level.
• The local back up for this role will be assumed by the Regulatory Responsible Person of the affiliate.
• Appoint as a responsible for controlled drugs and Lilly-designated Special Security Substance compliance by the affiliate general manager.
• As a point of contact to report counterfeit product to responsible product security officer and support local legal to take proper action

Basic Qualifications

• FDA GDP Qualification certificate or with FDA Pharma GDP knowledge and experience
• University degree in Pharmacist / Chemist-Pharmacist
• Licensed pharmacist is highly preferred
• Minimum 3 years experiences in quality control applied to the pharmaceutical
• industry and other related industries.
• Fluent in English (conversational, writing and reading)
• Knowledge and mastery of basic computing tools (Microsoft office).

Leadership ability to relate to others and achieve results through others.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly 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.