Associate Director Supplier Quality Management

Are you an experienced supplier quality professional who wants to take ownership of quality across a global network of suppliers? Do you enjoy combining hands-on auditing with strategic partnership in a global pharmaceutical company? Then the position as Associate Director, Supplier Quality Management at Asahi Kasei Therapeutics is something for you! About AKTX Asahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. AKTX is a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon their strong heritage of scientific innovation, AKTX aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions. The Asahi Kasei Group operates with a commitment of creating for tomorrow. Their business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. AKTX is looking for candidates that offer a fresh perspective and a variety of skills to help them achieve their commitment. AKTX’s Mission Pioneering innovation to continue addressing unmet medical needs, now and into the future AKTX’s Vision Positively impacting health by expanding therapeutic options that improve the lives of patients around the world AKTX’s Values Agility, Integrity, Innovation, Expertise and Accountability Diversity, Equity & Inclusion At Asahi Kasei Therapeutics, they believe that diverse perspectives strengthen innovation and help them better serve patients, colleagues, and communities around the world. They are committed to creating an inclusive workplace where everyone is treated with dignity, respect, and fairness and where all employees can contribute and succeed. AKTX is proud to be an equal opportunity employer and welcome applications from qualified candidates regardless of race, ethnicity, nationality, religion, sex, age, disability, sexual orientation, gender identity, or any other characteristic protected by applicable law. About the position as Associate Director Supplier Quality Management As Associate Director SQM, you are responsible for the qualification, oversight and performance of our international GxP suppliers and business partners, including Marketing Authorization Holders (MAHs). You provide independent quality oversight throughout the supplier lifecycle, from qualification and auditing to risk management, performance monitoring and issue resolution, with a focus on AKTX European and Asian portfolio of suppliers. You will work closely with Quality Operations, Clinical Operations, Technical Operations and Supply Chain, and be reporting to the Senior Director, Supplier Quality Management, in a role with real influence and room to grow. Key responsibilities include:

• Manage qualification, approval, ongoing oversight and periodic requalification of international GxP suppliers and partners, including CMOs, contract laboratories, packaging and distribution providers, and MAHs.
• Plan, lead, and conduct risk-based onsite and remote GxP audits of suppliers and partners to assess regulatory compliance, quality systems, and adherence to contractual obligations.
• Evaluate supplier audit responses, CAPAs and supplier complaints, ensuring timely resolution of deficiencies.
• Monitor supplier and MAH partner performance through quality metrics, scorecards, risk assessments and periodic business reviews, and lead quality discussions to drive improvement.
• Support the development and maintenance of Quality Agreements with suppliers and MAH partners.
• Maintain inspection-ready qualification records in the eQMS (Veeva Quality) and contribute to improving SQM processes, procedures and tools.
• Serve as primary SQM contact for assigned suppliers and partners and collaborate with internal stakeholders and external QPs.

The position includes approximately 20–30% international travel to suppliers across Europe, US and Asia. About you You are a polished professional who has no trouble speaking up, also when the message is not the one people want to hear, and you do it constructively in an open and positive working climate. You are happy to get hands-on, learn as much as you can and drive improvements. You value partnership and work well across functions, locations and cultures. Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering or a related discipline.
• 12+ years of pharmaceutical or biotechnology quality experience, including at least 5 years in Supplier Quality Management, external manufacturing oversight or GxP auditing.
• Strong auditing, analytical and quality risk management skills
• Strong GMP knowledge (EU GMP, GDP, ICH) and hands-on auditing experience, in particular of manufacturing sites.
• Experience managing international GxP suppliers and external partners.
• Understanding of MAH responsibilities, Quality Agreements and EU Qualified Person requirements.
• Strong risk-based decision making and the ability to manage multiple suppliers independently.
• Experience with electronic Quality Management Systems, preferably Veeva Quality.
• Fluent English, written and spoken, and willingness to travel approximately 20–30%.

Meritorious:

• Experience from a virtual pharmaceutical organization.
• Demonstrated ability to identify and implement process improvements.

What AKTX offers Make an Impact Contribute to therapies that improve the lives of patients around the world. Build Something New Help shape the future of Asahi Kasei Therapeutics as they bring together expertise, people, and capabilities into one global organization. One Global Team Work alongside colleagues across Europe, the United States, and Japan in a collaborative and inclusive environment. Grow With AKTX Enjoy opportunities for development, flexible working arrangements, and competitive local benefits. Details: Start: By agreement Scope: Full-time Location: Stockholm Does the position as Associate Director Supplier Quality Management at Asahi Kasei Therapeutics sound interesting? Applications are reviewed on an ongoing basis, so we encourage you to apply as soon as possible. Needo is looking forward to hearing from you!