Position Summary

• Senior Manager, Quality Assurance is responsible for ensuring the product or service is consistent and meets the requirements and established standards. This includes performing and managing tasks associated with GQP for production and distribution, GMP/GDP at outsourcing contractor, drug application, CMC relating maintenance and compliance of MHLW approval files for Alexion’s products. The position makes a selection of outsourcing contractors and collaborates with them when there is a need. In addition, the position implements Global SOPs in the country. Also Senior Manager should perform education of Qality work for Quality juniors.
• Either a managing role, providing leadership, direction and contribution to the organisation through motivation and development within the function. Or a technical role, leading small projects or segments of large cutting edge international projects, applying specialist knowledge in one subject area. Both roles will be expected to manage risk using evaluative judgements in complicated or novel situations. Is expected to have effective levels of interactive communication within the team and directly influencing and advising those within the team.

Principal Responsibilities

Quality professional with strong subject knowledge, both in depth and breadth. Experience from a number of different areas of quality. Will control, monitor and develop systems and procedures to enhance the approach quality across multiple disciplines. Responsible for managing quality assurance systems and procedures across multiple disciplines within Quality. Leads a team of quality professionals. Facilitates the production and distribution by performing tasks associated with GQP・GDP for production and distribution, such as creating SOP, managing and collaboration with contractors, shipping products to the market and quality assurance at the distribution process, CMC compliance and GMP periodical review. Working collaboratively with Global related department (CMC, RA), gathers correct information of overseas manufacturing facilities. Makes an application for change management on the application form for approved products appropriately and obtains the approval. Make an appropriate budget and proposal for quality assurance.

Qualifications

• Minimum 5 years work experience in GQP/GMP work at a pharmaceutical company.
• Minimum 5 years of experience in GQP/GMP work for products of biological origin.
• Must have knowledge of pharmaceutical regulations for products of biological origin including GMP and CMC after the amendment in 2005.

Education

• Bachelor’s degree or higher in pharmacy or science major.
• Proficiency in English to communicate with Global staff. (conference call, email)

Competencies

Decision Quality Functional/Technical Skills Motivating Others Attracts and Develops Top Talent Optimizes Work Processes

AstraZeneca 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.