Associate Director Global Material Certification
AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company renowned for the discovery, development, and commercialization of prescription medicines for some of the world’s most serious diseases. As one of the world’s leading pharmaceutical companies, we are committed to advancing science for the benefit of patients worldwide.
The Global Certification Group is dedicated to ensuring that Material Certification meets the highest standards and is delivered within agreed customer service lead-times. In this role, you will be instrumental in supporting the team by driving productivity through lean methodologies and providing technical expertise.
As the Associate Director Global Material Certification, you will provide leadership in integrating quality into our supply chain, enabling efficient delivery of safe and effective medicines while meeting global regulatory expectations. You will demonstrate your extensive knowledge of Quality Control and act as a Subject Matter Expert, focusing on enhancing our technical quality capabilities.
Accountabilities
- Team Leadership and Development: Lead and nurture a high-performing team by fostering a culture of continuous improvement and innovation. Provide training and coaching to enhance technical capabilities and manage team performance.
- Technical Expertise and Innovation: Act as a global subject matter expert by providing technical leadership and direction. Drive modernization and implementation of standard methodologies in material certification and data management.
- Process Standardization and Improvement: Enhance productivity and process effectiveness through lean methodologies. Standardize certification processes to ensure consistency and compliance across operations.
- Cross-Functional Collaboration: Build and influence a network of contacts within and outside AstraZeneca. Collaborate with IT and QC Network to deliver integrated systems and support a paperless lab environment.
- Project and Change Management: Lead or contribute to local, cross-functional, or global initiatives. Influence decision-making, find opportunities for change, and drive efficiency savings.
- Regulatory and Compliance Support: Support regulatory inspections and ensure compliance with industry standards. Maintain expert knowledge of analytical processes and quality systems.
- Risk and Performance Management: Establish metrics to track certification process efficiency and manage risks using evaluative judgment in complex situations.
Essential Skills/Experience
- Degree in a scientific subject area with 8-10 years of experience in a GMP (Good Manufacturing Practice) environment.
- In-depth knowledge of compliance management, GMP/GLP principles, and cGMPs. Familiarity with Quality Systems (including EQV, Change Controls) and pharmaceutical supply chain standards like Pharmacopeia.
- Exceptional oral and written communication abilities.
- Understanding of Lean processes and demonstrated experience in leading cross-functional improvement initiatives.
- Thorough understanding of the quality function and its integration with other business functions to achieve organizational objectives.
- Strong problem-solving, negotiating, and influencing skills with the ability to work independently and take the initiative.
- Proven project management experience, managing global projects and initiatives.
- Willingness to travel nationally and internationally up to 10% of the time.
Desirable Skills/Experience
- Experience working in a PCO/PET organization or Lean/Six Sigma training.
- Multi-site / multi-functional experience
- Proven experience in Quality assurance or combination of Quality and Technical
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Work on diversified tasks with a global team! Work on multiple projects while partnering with knowledgeable colleagues across multiple business functions. Be exposed to new ways of thinking, helping us grow collectively as individuals. This is a place where you will feel included in the conversation; every voice is heard and matters.
Ready to make an impact? Apply now!
Date Posted
06-Jan-2025Closing Date
19-Jan-2025AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.