募集要項
| 業務内容 |
OBJECTIVES/PURPOSE Deputy Site Quality Head. Provide leadership of Quality Control functions. Develop and drive mid and longterm strategy and operational excellence, training/education, talent review and personnel development Accountable for and manage all aspects of Quality Control at the facility, ensuring that quality systems, laboratory compliance and related functions are in place and meet current Good Manufacturing Practices (cGMP), other regulatory quality standards and requirements. Direct and ensure that laboratory operations are effective and carried out on schedule. Direct and ensure GMP compliant laboratory operations on site. Managing application of strategic goals Achievement of defined goals and targets in order to drive the Hikari plant to reach operational and compliance excellence ACCOUNTABILITIES Support Site Quality Head as deputy. Establish strategic goals for the Quality Control organization in alignment with the global and site strategy, and drive actions as needed to ensure timely delivery of goals. Lead and manage consistency in laboratory operations and data review process among Quality Control. Drive and lead new ways to improve and streamline current business and system processes. Identifies, manages, and where appropriate, leads multiple process/product improvement projects with the objective of achieving quality, efficiency and cost improvements. Responsible for the coaching, training, and development of the Quality Control team. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products. Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations. Excellent verbal and written communication skills in both Japanese and English. Adaptive communication and presentation skills to effectively reach different levels, including senior management. Skilled in Microsoft Office applications (Excel, Powerpoint, Word) Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), and SAP preferred. Leadership Strong leadership skills and demonstrated success in managing a team. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team. Adopt and exemplify the leadership behaviors throughout the GQ organization and Hikari Plant. Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Decision-making and Autonomy Must be able to deal with ambiguity, and make decisions under stressful conditions. Great sense of urgency. Interaction Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise Knowledge and experience in the field of analytical development and Quality Control function activities. Knowledge of the local and international regulatory regulations including GXP, ICH, other related guidelines. Knowledge in API, solid dosage forms, parenteral technology, biologics or combination products. Strong analytical and problem solving skills to make key decisions regarding potential risks associated with product quality or regulatory violations. Excellent verbal and written communication skills in both Japanese and English. Adaptive communication and presentation skills to effectively reach different levels, including senior management. Skilled in Microsoft Office applications (Excel, Powerpoint, Word) Experience/expertise with TrackWise Deviation/CAPA, Change Control Management (CCM), and SAP preferred. Leadership Strong leadership skills and demonstrated success in managing a team. Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team. Adopt and exemplify the leadership behaviors throughout the GQ organization and Hikari Plant. Must have the ability to act as a change agent as well as effectively lead and motivate team members to achieve team goals. Decision-making and Autonomy Must be able to deal with ambiguity, and make decisions under stressful conditions. Great sense of urgency. Interaction Interacts with the Site Quality Head and all site functions (EHS, HR, Finance, IT, Manufacturing, Engineering, Supply Chain, etc.) Interacts with global Quality functions and Regulatory Affairs, as well as local and global regulators. Interacts frequently with subordinates, functional peers, and the Senior Leadership Team. Innovation Strong knowledge of Quality Risk Management principles. Should be current in knowledge of state-of-the art processes and systems related to production as well as control of the products. Identify and implement strategic opportunities to drive cost reductions/process improvements in site-business. Lead and engage employees by initiatives of “Qualitiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements. Complexity Key stakeholders include but not limited to: Quality Assusrance, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities. |
|---|---|
| 雇用形態 | 正社員 |
| 応募資格 |
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline. At least 10 years of management experience in the following areas in the pharmaceutical in-dustry: Quality assurance, Quality Control; understanding of the requirements for manufacturing, plant utilities, computer systems and project management. In depth knowledge of applicable regulations and laws for medicinal products, such as FDA CFR, ICH, GMPs and guidelines. Well-knowledge related to Manufacturing, Finance, EHS and HR (incl. Labor law) Strong leadership skills (i.e. Communication, Coaching, Project Management, Decision Making, Problem Solving, Team building and etc.) Business level of English skill is necessary (both verbal and written) Preferred License for pharmacist MBA Experience of overseas assignment. Preferred to have experience in managing team with applicable EHS perspectives such as waste, waste water, exhaust gas, noise, GHG reduction, health, and safety. (5 years for department head and 3 years for Group Managers) Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site. ADDITIONAL INFORMATION Some travels will be required. This job description is not designed to be a complete list of all duties and responsibilities required of the position. |
| 英語力 | ビジネスレベル |
| 年収 | 1300万 〜 1700万円 |
| 給与詳細 |
■給与: 経験・スキルに応じ当社規定により決定します 基本給 月￥649,800～ ＊残業手当は残業時間に応じて別途支給 諸手当：通勤手当、住宅手当、残業手当等 昇給：毎年 賞与支給：年2回 想定年収 1300万円-1700万円 |
| 勤務地 | 山口県 |
| 備考 |
”Better Health for People, Brighter Future for the World” is the purpose of a company.We aim to create a diverse and inclusiveorganization where people can thrive, grow and realize their own potential while enabling our purpose. We continue to innovate and drive changes that will transformthe lives of patients. We’re looking for like-minded professionals to join us. global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of ism, whichhas been passed down since the company’s founding. ismincorporatesIntegrity, Fairness, Honesty, and Perseverance, with Integrity at the core. They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order. |
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