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Associate Director, Quality Services & Improvement
Provide leadership across the Quality organization to promote and drive strategic thinking and innovative approaches to change the business. This includes coordination of various change/transformation and continuous improvement initiatives (OPEX, CAPEX, Lab Transformation etc.) across the Plasma OpU as well as providing support as a member of the Quality Leadership Team (QLT). Facilitate the 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. Help achieve the Quality vision based on Science, Systems and People. 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 ensure the Quality culture that focuses on patients, including regulatory compliance, patient safety, continuous improvement, process efficiency, and problem prevention. Incumbent will uphold Takeda’s Quality Culture elements of keeping it simple, taking pride in doing it right, ensuring a speak up culture and owning and demonstrating commitment to Quality.
Essential Duties and Responsibilities:
- Facilitate development of strategies for an integrated quality approach & culture within the site organization and Plasma OpU in order to position/leverage Quality as a competitive advantage for Takeda.
- Coordinate Quality projects, initiatives, process improvements and best practice sharing across the Site quality organization; including appropriate tools and training.
- Build strong foundation for collaboration and ensure management of interdependencies across the organization with all internal business partners
- Provide executive sponsorship to Quality Initiatives to ensure initiatives stay on track and deliver results
- Lead Budget preparation efforts for Quality organization in collaboration with cost center managers
- Serve as liaison for Quality improvement best practice sharing for Quality organization and lead external bench marking activities for organizational development.
- Serve as gatekeeper for Quality CAPEX projects
- Drive and coordinate Digital Quality improvements.
- Develop a framework for innovation & new technology
- Drive involvement of SCIENCE-based thinking to ensure application of new technology and continuous improvement (e.g. OPEX/Lab Transformation)
- Provide executive sponsorship to key network forum groups, such as QC and Microbiology, to assure collaboration and alignment and efficiency of processes across the network.
- Assess laboratory and other technology gaps and partner with leaders to assure technology is in place where appropriate and centers of excellence are created as necessary to drive efficiency across the network
- Drive best practice and continuous improvement and digital initiatives
- Keep overview on budget and resource management for the QLT and partner with Site finance controller team
- Manage external influencing activities to track leadership involvement in key external industry & regulatory groups
- Maintain strong networks with industry groups and contacts in order to stay current with industry best practices and trends
- Provide leadership in coordination of talent management processes with SQLT and HR business partners.
- Engage in projects to ensure people development across the network
- Provide leadership to support to the SQLT on team meetings, agenda creation and minutes
- Actively champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation as well as adherence to the principles and values of Takeda-ism.
Education and/or experience:
- Typically requires bachelor's degree, preferably in science, engineering or other related technical field.8+ years of related experience with 3+ in a management role
- Preferred 8-10 years of leadership experience including managing projects and providing leadership coordination of activities at a site and global network level.
- Knowledge of and experience with developing culture and project activities to adhere to international regulations (e.g. FDA, EMEA), GcP, GMP and GDP guidelines, ICH, PIC/S and other relevant current industry standards
- Experience with IT systems and their application in a Quality organization
- Quality Experience in two or more of the following areas:Laboratory, Packaging, Labeling, Investigations and remediation of quality system deficiency
- Lean-6-sigma certification
- Experience from People Development function
Core Competencies / Skills:
- Demonstrated ability to drive innovation, continuous improvement and out of the box thinking in both structured and unstructured environments
- Strong communication skills - Ability to communicate ideas and data both verbally and in writing and in an actionable form.
- Strong collaboration and partnership skills with Quality collegues
- Analytical and critical Thinking Skills – utilizes observation, interpretation, analysis, inference, evaluation, explanation in decision making.
- Leadership Behaviors
- Demonstrate strategic thinking, finding innovative ways to serve patients and build trust, reputation and business
- Create the environment that inspires and enables people to move the organization forward
- Focus on the few priorities and deliver superior results
- Elevate the capabilities of the organization for now and the future
- Live the TAKEDA-ISM
- Putting the patient in the center
- Building trust with society
- Reinforcing our reputation
- Developing the business
- Must be able to lift, push, pull and carry up to 10 lbs.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning.
- Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold and/or wet environment.
- Must be able to work multiple shifts, including weekends.
- Non-Exempt Roles only: Must be able to work overtime as required.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
Other Job Requirements:
- Travel may be required as needed
- Working with multiple time zones may be required
- Coordinating activities with vendors, suppliers and partners as needed.
Location and Salary Information: This post excludes CO applicants
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.