エージェント取り扱い求人

Head of Quality Control (Senior Director)

募集中
  • 勤務地
    山口県
  • 職種
    品質管理担当
  • 業種
    医薬品メーカー(先発医薬品)

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), Takeda and 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 Takeda 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 Takeda 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 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.
Takeda isa global values-based, R&D-driven biopharmaceutical leader. We are guided by our values of Takeda-ism, whichhas been passed down since the company’s founding. Takeda-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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