Quality Manager

רמת השרון
משרה קבועה
משרה מלאה

לפני חודש

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.**Position Summary**The Quality Manager serves as both the Product Quality Representative (PQR) and the Qualified Person (QP) for the Israeli affiliate. This role is critical in ensuring compliance with Lilly Global Quality Standards, Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and local regulatory requirements. The Quality Manager will lead the implementation of the affiliate's quality system, oversee batch release, and act as a key liaison with regulatory authorities and internal stakeholders.**Main Purpose And Objectives Of Position**As Product Quality Representative (PQR):

Ensure the implementation and execution of Lilly Global Quality Standards at the affiliate.
Ensure the implementation and execution of an adequate product quality system based on Lilly Quality Standards and applicable local regulations.
Collaborate with the Regional Quality Team to seek advice, inputs and guidance in all related quality matters/projects.

As Qualified Person (QP)

Ensure compliance with Pharmacists Regulations (GMP for Products) 2010.
Certify that each batch released for marketing complies with the product registration and regulatory requirements.
Assist to global quality leader regarding policies, processes and procedures.

Scope: IsraelEducational Requirements

Knowledge of local procedures and Global Quality Standards relating to product quality system and batch release, other procedures related to the roles and responsibilities, and successful completion of the related knowledge assessments, if any.
The QP shall be a qualified pharmacist of at least two years' proven experience in an authorized business, in the activities of qualitative and quantitative analysis of active substances and medicinal products and of the testing and checking necessary to ensure the quality of medicinal products.

As part of the QP qualification, the QP is expected to visit the drug products manufacturing site.Educational & Professional Requirements

Pharmacy degree with a valid Pharmacist License in Israel.
Completion of a Qualified Person (QP) certification course.
Willingness to visit manufacturing sites as part of QP responsibilities.

Soft Skills

Decision-making capabilities in a regulated environment.
Strong interpersonal and communication skills, with the ability to influence cross-functional teams.
High level of accountability, integrity, and attention to detail.
Ability to prioritize, manage complexity, and adapt in a dynamic environment.
Proven ability to lead through change, foster collaboration, and drive continuous improvement.

Language Requirements

Fluent in Hebrew (spoken and written).
Fluent in English (spoken and written).

**Key Responsibilities**Legal Responsibility for the Qualified Person (QP):**About**The Responsible Pharmacist should accomplish the local regulations about the Responsible Pharmacist (Qualified Person) functions and product release. The chief duties of a responsible pharmacist are listed in the Pharmacists Regulations (GMP for Products) 2010:

To ensure that each batch of medicinal product released for marketing shall have been manufactured and tested in accordance with the terms set out in the Medicinal Products Ordinance and Regulations and in conformity with the product's terms of registration.
To certify in a register batch release documents and keep them in a special place under its responsibility; to keep the register up to date for a period of at least five years; the responsible pharmacist shall have the register available for the Director's inspection at any time.
The responsible pharmacist of an authorized business shall certify that every batch of medicinal product imported into Israel only after the batch has undergone a full qualitative analysis, in accordance with the requirements of the marketing authorization.

Routine Duties

To give notice to the Ministry of Health (MoH) in respect of every batch that is approved for marketing, after verified and tested the batch pursuant to the guidelines given in the clarification paper. Notice of release shall also be sent for a repeated batch.
Assure GMP records are properly maintained at the affiliate.
Ensure the validity of importation permits.
To evaluate and respond to pharmacies and consumers include inquiries concerning temperature excursions.

**For Product Quality Representative (PQR)**Implementation of the Product Quality System at the affiliate, covering but not limited to: Procedures system, Quality Manual and related activities, Training, Documentation and Data, Complaint system, Deviation system, Returned products management, Change Control system, Notification to Management system, Corrective and Preventive Actions (CAPA), Quality Plan, Quality systems trending, Recalls management, Product Complaints management, Regulatory compliance, GMP/Product Quality decisions in conjunction with Regional Quality Team, Physician Samples and Promotional Materials with GMP impact, Product Customization, Product Counterfeit Protection, Audit readiness & follow-up on audit finding and health authority inspection. Involvement in projects linked to Quality Systems at the affiliate such as: Product Receipt, Warehouse Management and Distribution management, customization initiatives and External Parties for GMP activities.Other Responsibilities

Act as back-up for the affiliate Responsible Complaint Person (RCP).
Perform as the affiliate Regulatory, Quality, Pharmacovigilance Department and MSLs Record Information Management (RIM) Steward for the and assure implementation of the Global RIM program.
Perform as the Recall Coordinate - responsible to coordinate recall information to Regional Quality Leader/Affiliate team/Israeli MoH.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.#WeAreLilly⚠הגש מועמדות באתר החברהמשרות דומות שיכולות לעניין אותך13/07/2025רעננהמספר משרה - 416065דרוש/ה qa manager ניהול 4-5 עובדים אך יחד עם זאת hands on באחוזים גבוהים דיווח למנהל התוכנהממקומת ברעננה- אין אפשרות למודל היב...14/07/2025פתח תקווה, 11.31 ק"מ ממיקומךדרוש.ה מנהל.ת הבטחת איכות לחברת דרמו־קוסמטיקה מובילה בפתח תקווההתפקיד כולל הובלת תחום האיכות במפעל: תכנון תהליכים, בקרת ייצור, ניהול תקנים (gmp, ...07/07/2025תל אביב, 13.91 ק"מ ממיקומךדרוש/ה בודק/ת תוכנה qa לארגון מוביל בת"אתיאור התפקיד: הגדרת תפקיד: כפיפות לראש צוות qa כתיבת תסריטי בדיקות ביצוע בדיקות בסביבות נמוכות ובדיקות ...15/07/2025מרכז, 14.9 ק"מ ממיקומךלחברת מזון דרוש/ה מנהל/ת איכות -ניסיון רלוונטי מחברות מזון (או תחום קרוב) - חובה! -ניסיון בכתיבה והטמעה של נהלי עבודה - יתרון! השכלה רלוונטית אזור: ...18/07/2025תל אביב, 13.91 ק"מ ממיקומךElbit Systems Israelמנהל.ת איכות ספקיםזיהוי דרישה: 3592מיקום גאוגרפי: שרוןחברה: ElbitSystemsעיר: רמת השרוןתיאור משרהלאתר החברה ברמת הש...19/07/2025מרכז, 14.9 ק"מ ממיקומךIAI - Israel Aerospace IndustriesWe are looking for a Project Quality Manager to join our Defense Plant in the Missile and Space Systems Division, IAI.**The position include...20/07/2025תל אביב, 13.91 ק"מ ממיקומךCheck Point SoftwareWhy Join Us?We're looking for a skilled and motivated QA Team Leader with a strong background in web application and network security testing. T...20/07/2025תל אביב, 13.91 ק"מ ממיקומךOverwolfWe're on the hunt for a sharp and mission-driven QA Team Leader to join our Apps Platform group - the tech behind hundreds of apps powering millions o...17/07/2025תל אביב, 13.91 ק"מ ממיקומךeTeacher GroupeTeacher Group is an EdTech pioneer and innovator that has been on the cutting edge of educational technology since its foundation. Today our company ...קצת עלינוMploy הוא לוח דרושים מבוסס AI, שנועד לסייע למחפשי עבודה ולמעסיקים כאחד, תוך יצירת פלטפורמה חדשנית, איכותית המובילה את שוק העבודה בישראל.אנו מאגדים משרות עדכניות מאלפי מקורות בארץ, ומנגישים אותן ביעילות באמצעות סוכן AI חכם שמתאים משרות רלוונטיות למועמדים ומאפשר הגשת מועמדות בלחיצת כפתור.הפלטפורמה שלנו מציעה התאמות משרות מבוססות בינה מלאכותית עם אחוז התאמה אישי, קבוצות WhatsApp ייעודיות לפי תחום, ואפליקציה מתקדמת שמאפשרת חיפוש ושליחת קורות חיים מכל מקום ובכל זמן.Mploy אצלכם בוואטסאפ✨ רוצים להתעדכן בכל המשרות הכי שוות ישר לנייד?הצטרפו לקבוצות הוואטסאפ שלנו וקבלו את כל ההצעות המתאימות - בלי לחפש, ובלי לפספס. מחכים לכם! 📱😊

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