Description
What if you could join a company where every challenge is an opportunity to excel, and every opportunity is seized to make a lasting impact on the lives of patients?
Joining Amgen means becoming part of a community that is passionate about transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. It’s an opportunity to work alongside the brightest minds in the industry, fueled by our diverse culture, in an environment that fosters innovation, encourages professional growth, and values the unique contributions of each team member.
Amgen’s mission of serving patients has driven a recognition of Amgen as a world leader in biotechnology, earning accolades for its innovative approach to healthcare and its commitment to improving lives. With a history of pioneering protein-based medicines and a focus on genetic validation, we pride ourselves on our ability to bring vital medicines to patients around the world who need them. Our culture is a tapestry woven from the diverse threads of its workforce, each thread strengthening the fabric of Amgen’s identity. Here, every voice is heard, every contribution valued, and every individual empowered to make a difference. It is a place where the spirit of science and the passion for progress come together to create a brighter, healthier future for all.
**Senior Director Quality Assurance (Quality Site Head)**
At Amgen Breda Amgen’s investigational and commercial drug products are labelled, assembled, secondary packed, stored and released to various countries worldwide Activities also extend to importation of semi-finished drug products (as applicable) and distribution. Every day more than 1000 people from diverse backgrounds (42 different nationalities) are working on supply chain processes, manufacturing, marketing and sales of our medicines and clinical research into new medicines.
We are seeking an accomplished and driven Quality Professional to assume the role of Senior Director of Quality. Within this role, you will lead, direct and inspire the Quality function for our Breda Operations Site and will be a key member of the Site Leadership team to contribute to the site strategy development and deployment and provide quality consultation to your peers and site. In this pivotal role, you will ensure that our products are manufactured, stored, and distributed according to with current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other relevant regulations and specifications.
In this vital role you will:
+ Lead and oversee a team of roughly 50 employees including several direct reports (senior managers) to define and achieve Quality Assurance objectives that support the success of Breda Site Operations.
+ Provide Quality Oversight for labeling, packaging, warehouse, and distribution operations across Clinical and Commercial operations.
+ Ensure Quality Oversight and disposition (approval or rejection) of raw materials, pharmaceutical products, production records, documents, and procedures.
+ Implement and maintain the Amgen Quality Management System (QMS) at the site level, adhering to corporate standards and continuously reviewing and improving the QMS, our systems and processes.
+ Make independent decisions on materials and quality/compliance matters for the Site. Act as a key decision-maker in product recall processes and promptly alert senior management to significant quality, compliance, supply, and safety risks.
+ Offer expert advice to top management based on quality assurance and compliance expertise, translating global regulations into operational guidelines. Collaborate extensively with cross-functional internal partners ( Quality, Manufacturing, Engineering, PD, Regulatory Affairs) and external industry leaders.
+ Develop long-term development and succession plans to anticipate and improve the Quality organization’s capabilities in meeting business objectives.
+ Engage frequently with regulatory authorities worldwide, applying influence and negotiation skills during inspections and filing-related matters.
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The new colleague we seek is highly motivated to join our mission and has these qualifications:
+ Bachelor’s degree required; advanced degree (Master’s, PhD) preferred in Science, Engineering, or Pharmacy.
+ Preferred candidate must be QP eligible
+ 15+ years of relevant industry experience with a strong background in pharmaceutical or biotech processing and GMP Education regulations.
+ Expertise in GDP and GMP regulations for EU and US markets.
+ Proven leadership in Quality Assurance, strategic influencing, and project management, with outstanding decision-making abilities and strong organizational savviness.
**What you can expect from us**
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being. Therefore, Amgen is regularly recognized as a Best Place To Work ©.
+ Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent.
+ Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act.
+ Focus on innovation by implementing Microsoft Copilot and other business automation solutions.
+ Generous Total Rewards Plan comprising competitive salary, bonus structure, fixed 13th month, holiday allowance and a collective health insurance.
+ Focus on vitality with an on-site gym, vitality program and a restaurant with healthy food.
+ Flexible work arrangement.
