【Alexion Japan】 Associate Director, Japan Country Quality

Principal Responsibilities

• Partner and collaborate with leads and colleagues to ensure the roll out and on-going compliance to Alexion’s global quality and compliance systems, and associated procedures and standards to the JP organization.
• Provide leadership and resource management support to the technical transfer to local CMO and/or the analytical laboratory for the incoming test in Japan.
• Ensure that Alexion Policies, Global Quality Standards Operating Procedures (SOPs) are implemented in accordance with global and local GDP, GXP and PV guidelines.
• To overview, support and provide guidance for manufacturing plants, local and overseas, so that they can perform appropriate manufacturing and quality control, in accordance to the current GQP Ministerial Ordinance
• Represent Quality in the CMC team of projects and provide input into CMC planning, coordination, and decision making to provide technology transfer and validation support
• Approver of all GMP documents requiring Quality approval including Investigations, Change Controls, Validation Documents, Specifications, Complaints, Master Batch Record
• Provide support and acts as point of contact during regulatory health inspections as needed and lead inspection readiness activities in collaboration with other functional groups
• Ensure inspection readiness for GXP-impacting activities in the Commercial organization; work with cross-functional colleagues to analyze risks and develop inspection readiness strategy
• Product support in the technical aspects of project and manufacturing transfer (overseas sites / Japan), process improvement action, the validation planning and implementation improve the quality of surface and manufacturing process
• Monitor GXP, GDP and Pharmacovigilance compliance to regulations and Alexion’s procedures and communicate CAPAs and action plans to Country Management and Corporate Quality
• Ensure the products are produced, tested, and released in compliance with SOPs, cGMPs and local regulations such as GQP
• Make decisions regarding quality and compliance for products including release and reject decisions in GQP term
• Coach the team member to grow and cultivate them as Quality representative.
• Build the network in Global Quality organization to boost the presence of Japan affiliate
• The budget related to new launch program such as analytical tech transfer, QC testing of the commercial product needs to be managed. And properly input such a cost to the internal stakeholders.
• Communicate the external stakeholders such as CMO/CLO in timely fashion and build/maintain the mutual trust
• Understand and oversee the Coupa System for the payment to the local vender

Quality manager responsibilities

• Ensure the products are produced, tested, and released in compliance with SOPs, cGMP and local regulations such as GQP
• Make decisions regarding quality and compliance for products including release and reject decisions in GQP term
• Negotiate and maintain the Quality Agreement and ensure compliance
• Ensure compliance with internal standards and regulatory requirements
• Final approver of all GMP documents requiring Quality approval including Investigations, Change Controls, Validation Documents, Specifications, Complaints, Master Batch Records
• Support quality management implementation and maintenance;
• Focus on the management of authorized activities and the accuracy and quality of records;
• Ensure initial and continuous training programs are implemented and maintained;
• Coordinate and promptly perform any recall operations for medicinal products;
• Ensure relevant customer complaints are dealt with effectively;
• Ensure suppliers and customers are approved;
• Approve any subcontracted activities which may impact on GDP;
• Ensure that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place;
• Keep appropriate records of any delegated duties;
• Decide on the final disposition of returned, rejected, recalled or falsified products;
• Approve any returns to saleable stock;
• Ensure additional requirements imposed on certain products by national law are adhered to
• Ensure the implementation and maintenance of quality systems and procedures to ensure compliance with GMP/GQP and other requirements

Qualifications

• 8+ years of hands-on Quality Assurance / Compliance and management experience in pharmaceutical/ biotech industry.
• Thorough knowledge of applicable local and global regulatory requirements required for GXP compliance.
• Thorough knowledge of CMC science such as the process validation, QC testing and so on
• Good knowledge of government regulations and guidelines (local, EMA, FDA, PMDA) pertaining to GXP and Pharmacovigilance required
• Extensive knowledge in a broad range of pharmaceutical activities and Quality Systems.
• Exceptional communication and interpersonal skills to cultivate the good relation with the business partners such as CMO, analytical labs and so on.
• Ability to work globally in a matrix environment
• Ability to work in a dynamic environment and to constantly redefine the scope of responsibilities in alignment with compliance and business needs
• Strong leadership ability.
• Strong organizational ability
• Strong communication skills
• Leadership and accountability for outcomes and project completion
• Fluency in English/Japanese

Education

• Bachelor's Degree in physical /life science or pharmacy; Advanced degree preferable

Date Posted

Closing Date

Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.