Country Quality Manager - QP / GDP RP

at  Sandoz

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our ‘new’ Sandoz!

Essential Requirements:

• University degree in life sciences (e.g. chemistry, pharmacy or other life sciences) – advanced degree desirable;
• Registration on the list of Qualified Persons as required per RD 14/12/2006;
• Strong knowledge of GMP/GDP legislative requirements and work experience in a quality organization
• Fluency in Dutch or French and English is essential.
• Ability to maintain the highest degree of integrity and to represent the company’s highest ethics, moral behavior and professionalism;
• Capacity to work in a high paced and constantly changing environment - Eager to learn, problem solving mindset, business acumen and corporate mindset;
• Open, pro-active and positive mindset, agile, flexible & resilient even when resistance;
• Eye for detail, accuracy and punctuality - Good sense of organization, planning, priority setting and initiative - Ability to read, interpret and transcribe data accurately;
• Excellent communication and diplomacy skills;
• Excellent administrative management skills;
• Good interpersonal savvy;
• Hands-on experience with MS excel and other electronic platforms such as SAP, Trackwise

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

• Ensure that the requirement of Good Distribution Practices are implemented and maintained within the quality management system;
• Ensure that the applicable Medical Device legislative requirements are implemented and maintained within the quality management system and that Medical Devices are distributed in compliance with FAHMP “Guidance for Distributors of Medical Devices”;
• Act as the main contact for competent authorities for Medical Devices;
• Act as the key point of contact for Warehouse and Distribution;
• Support in performing QP batch (import) certification and release for market and distribution in accordance with marketing authorization and GMP requirements;
• Support in document, deviation, change control, complaint, CAPA and incident management within area of expertise;
• Support in preparing for local repackaging activities (components check, release for artwork, etc.);
• Artwork quality review and approval for commercial products
• Support in document, deviation, change control, complaint, CAPA and incident management within area of expertise;
• Prepare, review or approve local standard operating procedures within area of expertise;
• Support in inspection / audit (readiness) within area of responsibility;
• Participation in the organization’s back-up system to ensure business continuity;
• KPI’s include:
• Insure adherence to KQIs within area of responsibility;

• Sustained implementation and maintenance of key quality systems;No competent authorities’ overdue commitments from inspections within area of expertise

WHAT YOU’LL BRING TO THE ROLE:

Essential Requirements:

• University degree in life sciences (e.g. chemistry, pharmacy or other life sciences) – advanced degree desirable;
• Registration on the list of Qualified Persons as required per RD 14/12/2006;
• Strong knowledge of GMP/GDP legislative requirements and work experience in a quality organization
• Fluency in Dutch or French and English is essential.
• Ability to maintain the highest degree of integrity and to represent the company’s highest ethics, moral behavior and professionalism;
• Capacity to work in a high paced and constantly changing environment - Eager to learn, problem solving mindset, business acumen and corporate mindset;
• Open, pro-active and positive mindset, agile, flexible & resilient even when resistance;
• Eye for detail, accuracy and punctuality - Good sense of organization, planning, priority setting and initiative - Ability to read, interpret and transcribe data accurately;
• Excellent communication and diplomacy skills;
• Excellent administrative management skills;
• Good interpersonal savvy;
• Hands-on experience with MS excel and other electronic platforms such as SAP, Trackwise.