Head of Quality Systems & Compliance (Senior Director)

Head of Quality Systems & Compliance (Senior Director)

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Job Description

OBJECTIVES/PURPOSE

• Provide leadership and oversight to the Quality Systems & Compliance function, and continuously develop people and teams.
• Managing all aspects of Quality Systems & Compliance at the facility, ensuring that quality systems, processes and related functions are in place and meet current Good Manufacturing Practices (cGMP), Takeda and other regulatory quality standards and requirements.
• Ensure the quality, safety and compliance of commercial products released to markets.
• Manage through subordinates the coordination of the activities of several functions within the Quality organization including the Deviation/CAPA and Change Control, Validation Quality, Compliance, Inspections and Audits, Supplier Quality, Quality IT and Product Complaint Management.   
• 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

• Establishes goals for the Quality Systems & Compliance department in alignment with the global and site strategy, and takes action as needed to ensure timely delivery of goals.
• Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, and the regulations and standards applicable to site operations.
• Timely implements local procedures with consistency to global Quality Management System procedures in several departments and manages compliance.
• Understands and assures conformance to applicable regulations. Interfaces with regulators during inspections in the roles of escort and SME concerning Deviation/CAPA, Change Control, Internal audit program, Quality IT, Supplier Quality and Product Complaint Management.
• Responsible for Quality Council, including summaries of the data presented, conclusions, meeting minutes, and tracking action of items to closure.
• Responsible for the submission of annual Product Quality Reviews. 
• Reviews site-impacting regulatory submissions working with Subject Matter Experts to assure timeliness and accuracy.
• Manages Product Complaint process and coordinates complaint escalations for review, product hold and Field Corrective Action.
• Responsible for Validation Quality and the oversight of the site Validation Master Plan and critical Engineering programs.
• Seeks 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 Systems & Compliance team.

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.
• 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(Vision, strategy and business alignment, people management, communication, influencing others, managing change)

• Strong leadership skills and demonstrated success in managing a team.
• Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, egender 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(The capacity and authority to make organizational decisions, autonomy in decision-making, complexity of decisions, impact of decisions, problem-solving)

• Must be able to deal with ambiguity, and make decisions under stressful conditions.
• Great sense of urgency.

Interaction(The span and nature of one’s engagement with others when performing one’s job, internal and external relationships)

• 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(The required level of scientific knowledge, knowledge sharing, innovation and risk taking)

• 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 “Qualtiy Culture”, "AGILE 4.0" "Digital" to drive continuous improvements.

Complexity(Products managed, mix of businesses, internal and/or external business environment, cultural considerations)

• 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:(List the essential and desirable education and competency requirements to perform the primary responsibilities of the job.  Any minimum requirements should be noted.)

• 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 manufactur-ing, 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.

Locations

Hikari, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0027448