Lead, Quality Services & Improvement

募集要項

仕事内容

OBJECTIVES/PURPOSE

Change the business in line with standard site Quality Organizational Model:

Provide leadership across the Quality organization to promote and drive strategic thinking and innovative approaches to change the business

Drive and lead various change/transformation and continuous improvement initiatives and facilitate development of Quality Strategies to ensure a harmonized and integrated quality approach that will provide oversight and governance to enable Site Quality to successfully change the business

Build and promote a Quality Culture through collaboration and partnerships, innovation, continuous improvement, and a learning environment that includes knowledge and best-practices sharing

Leverage science, systems, and people as key elements to direct the Quality Culture that focuses on patients, including regulatory compliance, patient safety, continuous improvement, pro-cess efficiency, and problem prevention

Responsible for a timely and effective communication and escalation process to Site Quality Head in order to raise quality and safety issues

Responsible for the department expenses and department budget planning

Ensures adherence to EHS program

ACCOUNTABILITIES

・Strategy

Lead and facilitate development of strategies for an integrated quality approach & culture in the organization

Drive and coordinate Quality projects, initiatives, process improvements and best practice sharing across the Site quality organization; including appropriate tools and training

Provide executive sponsorship to Quality Initiatives to ensure initiatives stay on track and deliver results

Build and lead strong foundation for collaboration and ensure management of interdependencies across the organization with all internal business partners

・Services

Lead overview on budget and resource management for the Site Quality Leadership

Lead and manage external influencing activities to track leadership involvement in key external industry & regulatory groups and maintain strong networks with industry groups and contacts in order to stay current with industry best practices and trends

経験・資格

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DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

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), SAP and Electronic Batch Management (EBM) systems 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 Osaka 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 “Quality Culture”, "AGILE 4.0" "Digital" to drive continuous improvements.

Complexity

Key stakeholders include but not limited to: Quality Control, Manufacturing, Supply Chain, Distribution, IT, Manufacturing Sciences, Pharmacovigilance, Regulatory Affairs, and Health Authorities.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Bachelor’s degree in Chemistry, Pharmacy, Engineering, Biology or related discipline.

Management experience in the following areas in the pharmaceutical industry: 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

Lean-6-sigma certification

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.

Preferred to have experience in ISO 14001/45001 management system to carry out continuous improvement of site.

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勤務地

大阪府大阪市

Recruiting No.

02000762000750

企業情報

社名

国内大手製薬メーカー

事業内容

医薬品の研究開発・製造・販売