Head of Quality Systems & Compliance (Senior Director)
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
A Global Top Employer
Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2020.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2020.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Head of Quality Systems & Compliance (Senior Director)Apply Now
- 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
- 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)
- License for pharmacist
- 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.
Job ID R0027448