Group Manager, Head of API Quality Assurance

OBJECTIVES/PURPOSE

• Provide leadership of Quality Assurance functions. Develops and deploys mid and longterm plan with KPIs and operational excellence, training/education, talent review and personnel development.

• Managing aspects of Quality Assurance of API products,  at the site, 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 GMP compliant release of product manufactured and released on site, resp. the Mar-keting Authorizaton.

• Review and approve site deviation investigations and assess product impact.

• Responsible for excecution and review of Change Control and Validation.

• Drive GMP on the shopfloor adherence in manufacturing area.

• Achievement of defined plan with KPIs in order to drive the Hikari plant to reach operational and compliance excellence.

ACCOUNTABILITIES

• Manages the API Quality Assurance organization making sure the site goals are cascaded into the department.

• Support Product Shipping / Release Process and Product Disposition according to Hikari site Shipping and Release target dates

• Review and approve plant deviation investigations and product impact assessments

• Excecute and review Change Control and Validation

• Guarantee that systems under Quality Assurance are managed according to Quality Systems global and local procedures and metrics.

• Manage Quality on the floor activities in order to guarantee GMP Compliance and Continuous Improvement in Manufacturing areas

• Manage the bioburden control program for process intermediates, critical/support systems and cleanrooms and perform investigations in case of deviations or negative trends.

• Support manufacturing department during day by day activities and act as primary Quality contact for issues containment and resolution

• Support Quality Control, Warehouses, Engineering and other supporting functions during day by day activities and act as primary Quality contact for issues containment and resolution

• Responsible for the coaching, training, and development of the team and talent.

• Ensures adherence to EHS program.

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, 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

• 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 “Qualtiy 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.

• At least 5 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.

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.