ASSOCIATE DIRECTOR, QC MICROBIOLOGY MANAGEMENT LEAD　

Job Description ABOUT TAKEDA “Better Health for People, Brighter Future for the World” is the purpose of a company.
We aim to create a diverse and inclusive organization where people can thrive, grow and realize their own potential while enabling our purpose.
We continue to innovate and drive changes that will transform the lives of patients.
We’re looking for like-minded professionals to join us.
Takeda is a global values-based, R&D-driven biopharmaceutical leader.
We are guided by our values of Takeda-ism, which has been passed down since the company’s founding.
Takeda-ism incorporates Integrity, Fairness, Honesty, and Perseverance, with Integrity at the core.
They are brought to life through actions based on Patient-Trust-Reputation-Business, in this order.
OBJECTIVES/PURPOSE.
Planning, coordinating, and supervising the microbiological activities of the Quality Control Laboratory and the Environmental and Utilities Monitoring Program of a new plasma facility.
Developing and reviewing documentation associated with laboratory tests (SOPs, validation, and qualification protocols).
Ensuring compliance with local and global SOPs, reference specifications, FDA, PIC/S, and cGMP regulations and guidance.
ACCOUNTABILITIES.
Coordinating and supervising the implementation and execution of the microbiological activities and associated computerized systems of the Quality Control Laboratory and the Environmental Qualification and Monitoring activities for a new plasma products facility.
Support and ensure proper implementation and qualification/validation of microbiological testing and associated equipment and computerized systems.
Ensuring the correct implementation, execution and approval of analytical tests and laboratory information management systems.
Ensuring the validation status of laboratory methods.
reviewing/approving validation and qualification protocols.
Ensuring proper management of laboratory investigations.
Ensuring calibration and maintenance activities of laboratory equipment.
Serving as Deviation CAPA Owner and Change Control Owner.
Collaborating with global and local teams by providing analytical and microbiological technical support.
Participating in management reviews and periodic Tier activities for trend analysis of microbiological data.
Collaborating with the Validation group in managing process validation and environmental, equipment, and utility qualification activities.
Collaborating on internal and external audits as an SME or Lead Auditor.
Ensuring the implementation and maintenance of continuous improvement activities (LeanLab, 5S) within the area of competence.
Reviewing documents related to critical fluid and classified area monitoring programs.
Maintaining the budget for the Microbiological Laboratory.
Lead the Microbiology testing group members EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS.
University degree in scientific subjects such as Pharmacy, Biology, or similar.
Excellent knowledge of global (JP/US/EU) cGMP regulations and ICH and Pharmacopoeial requirements.
Group leader experience (>5yr).
Industrial (preferably pharmaceutical or comparable) microbiological testing experience (> 5yr).
Experience with microbiological environmental monitoring (>5yr), EMRA preparation, EMPQ execution.
Aseptic process simulation experience preferred.
Experience with Growth Direct/MODA preferred.
Business/technical English and Japanese communication skills.
Result-driven.
Comfortable in a complex and international environment.
Strong skills to work in matrix organization with excellent interpersonal, communication, influencing, and negotiation skills, to effectively communicate with all levels of professionals, both internal and external.