Lead Quality Assurance Manager CMO
vor 3 Wochen
With a rich history spanning over 120 years and a dedicated workforce of more than 17,000 employees across 20 countries, Daiichi Sankyo is committed to pioneering, developing, and delivering innovative care standards that enhance the quality of life globally.
Our Focus in Europe:
Our Specialty Business is dedicated to combating cardiovascular diseases, the primary cause of mortality in Europe, and ensuring that patients can cherish every moment of their lives. In the field of Oncology, we aim to establish ourselves as a global pharmaceutical innovator, developing groundbreaking therapies for cancer patients.
We are currently seeking highly qualified candidates for the position of:
Senior Quality Manager CMO (m/f/x)- Drug Product Manufacturing
Purpose of the Role: In this position, you will serve as the main point of contact for all quality-related matters at contract manufacturing organizations (CMOs). As the Quality Manager for CMOs, you will oversee quality assurance at these organizations, ensuring the implementation and maintenance of Daiichi Sankyo's quality standards (GMP/GDP) and regulatory requirements for our oncology products. Additionally, you will provide expert support to other functions within Daiichi Sankyo regarding quality topics and processes.
Key Responsibilities:
- Oversee quality management at CMOs, addressing quality-related issues such as change control, deviations, and complaints concerning Daiichi Sankyo products.
- Collaborate with CMOs to define effective Corrective and Preventive Actions (CAPAs) and monitor their timely execution.
- Independently review, assess, and approve documents such as Annual Product Quality Reviews (APQRs), Process Performance Qualification (PPQ) reports, and Continued Process Verification (CPV) documents.
- Prepare and negotiate Quality Assurance Agreements (QAAs) with CMOs, ensuring compliance with Daiichi Sankyo's standards.
- Participate in the establishment of new manufacturing processes and site transfer activities, acting as a quality subject matter expert during PPQ and validation activities.
- Support CMOs during regulatory inspections and conduct audits on behalf of Daiichi Sankyo as necessary.
- Identify quality risks at CMOs and escalate issues when required.
Global Information Distribution:
In this role, you will assist global teams and subject matter experts in identifying and defining quality requirements for CMOs. You will share quality-related information from CMOs with our global stakeholders within the quality assurance environment and during interdepartmental meetings.
Contribute to the Development of the Corporate Quality Management System:
As a subject matter expert in global working teams, you will help enhance Daiichi Sankyo's quality system and global Standard Operating Procedures (SOPs). You will share your knowledge and expertise within the quality assurance team and other functions to improve CMO management at Daiichi Sankyo. This role requires close collaboration with various departments, including Supply Chain, CMC, and regulatory functions, to ensure consistent market supply of products that meet our high-quality standards.
Qualifications and Experience:
- University degree in natural or pharmaceutical sciences, preferably in Pharmacy, Biotechnology, Microbiology, or a related field.
- A minimum of five years of relevant experience in the pharmaceutical industry, including at least two years in Quality Assurance and/or Quality Management, ideally in Shop Floor QA activities or as QA Oversight for Manufacturing Activities in sterile environments.
- At least two years of experience in a GxP environment within a Fill & Finish manufacturing department for sterile solutions and/or lyophilisates.
- Strong knowledge of international GMP/GDP regulations.
- Expertise in parenteral biological manufacturing, particularly in the production of sterile medicinal products or biological active substances, is preferred.
- Assertive communication skills, with a diplomatic approach during negotiations.
- A collaborative team player with a strong focus on quality and a solution-oriented mindset.
- Proficient written and verbal communication skills in English and German.
- Experience managing CMOs or external suppliers is advantageous.
- Project management skills are a plus.
- Willingness to travel (up to 10%, both domestic and international).
Why Join Us?
Working at Daiichi Sankyo is more than just a job; it is an opportunity to make a meaningful impact on patients' lives. We strive to achieve our ambitious goals together, fostering a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. Here, you will have the chance to grow, think innovatively, and contribute your ideas. If you possess a proactive mindset and a passion for addressing patient needs, we look forward to your application.
For more information:
www.daiichi-sankyo.eu
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