【AstraZeneca】【JOPS】Director PQS and PSP, Director Pharmaceutical Quality System and Product Security Pharmacist

Job Description

• Ensure Pharmaceutical Quality System and supporting processes are in place and implemented across the site for compliance and license to operate.
• Ensure compliance with AstraZeneca Quality standards, Safety Health and Environment requirements.
• Has technical oversight and responsibility for the quality and GMP/GDP compliance approaches and outcomes into the operations business area.
• Direct quality initiatives and improvement program aimed at ensuring compliance, continuous improvement, enhancing commitment to quality and improving profitability.
• Leading all internal and external inspection management.
• Act as point of contact for regulatory bodies at site, dealing with and resolving the complex issues.
• Be responsible for ensuring that the requirements and implications of all applicable external regulations are understood, the risks and opportunities are identified during assessment and communicated to the right stakeholders for information, advice and decision.
• Be responsible for ensuring that AstraZeneca is involved with and influential in key external organizations and events that interact with the local agencies that oversee and regulate the pharmaceutical industry within Japan.
• Proactively look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.
• Proactively work with Regional/Global Quality network to share good practices and learning. Lead significant local cross-functional initiatives and above site initiatives in the regional/global network.
• Lead and provide guidance in the daily job of the team. Build and develop team and personnel capability. Optimize performance outcomes of direct reports and ensure high quality IDP review.
• Build and develop strong Quality talent pipeline for site Quality function and wider network.

【経験/ Experience】

必須/ Mandatory

• Substantial relevant experience in pharmaceutical quality, manufacturing or regulatory roles
• Experience working within cross functional and global teams
• Track record of working with regulatory health authorities/ stakeholders/ government bodies / industry associations
• Experience of establishing and sustaining regulatory compliance culture

• Extensive work experience and deep understanding of culture(s) in Japan market
• Familiarity with the regulations in Japan
• Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
• Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

歓迎/ Nice to have

• Lived and worked outside of Japan
• Experience within a complex manufacturing/supply site environment
• Experience in GQP roles

【語学、スキル等/ Languages/Skills】

必須/ Mandatory

• Fluent in Japanese and English
• Bachelor’s degree and Licensed Pharmacist (Japan)
• Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills

歓迎/ Nice to have

• Ability to work externally and represent AstraZeneca with external industry associations

• Excellent knowledge of AstraZeneca policies, procedures and guidelines

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.