- Provide strategic leadership to the Takeda Clinical QA Program Managers and partner with key stakeholders that are integral to clinical development activities, as applicable.
- Contribute to the design and implementation of Takeda s risk-based GCP audit and compliance oversight activities.
- Monitor effectiveness of GCP processes through risk-based audits and GCP compliance activities, and provide actionable data to Senior Management based on identified compliance issues and trends.
- Oversee and provide necessary support for the GCP components of Regulatory Inspections.
Leadership & Partnership
- Provides leadership and guidance to the Takeda Research and Development Clinical Compound Support Quality Assurance Program Managers to ensure the development and implementation of strategies regarding the processes, procedures and quality standards required are maintained in compliance with applicable regulations, as applicable.
- Provides ongoing development of the Clinical Quality Assurance (CQA) Program Managers, including staff selection, work assignments, goal completion, development plan review, and performance management, as applicable.
- Establishes strong partnership/relationship with business stakeholders
- Recognized as a senior strategic GCP and bioanalytical quality resource
Design & Implementation of Audit & Compliance Monitoring Programs
- Develops and implements a strategic audit plan in collaboration with R&D Global Compound Support Leaders.
- Maximizes effectiveness and efficiency in the use of internal and external Compound Support resources.
- Ensures audit observation, report, and rating consistency for assigned area of responsibility.
- Ensures activities are conducted and reports written according to applicable SOPs and regulations.
- Provide quality assurance leadership and influence to drug development teams.
- Acts as a quality resource with expertise in regulations relating to GCP, ICH guidelines, and Clinical Operations SOPS.
- Responsible for the QA due diligence for new compounds/alliances for Quality, in collaboration with senior management in QA.
- Manage Therapeutic Area Programs of a highly complex nature and/or high risk programs including, multiple indications, data safety monitoring boards, endpoint review committees as well as those requiring the coordination of multiple nitch vendors
Interpret the GCP State of Compliance
- Supervises and oversee the analysis of audit program results, quality issues and investigations in order to optimize regional operations and global state of compliance.
- Generates and interprets data for Quality Council and global compliance reports.
- Works in collaboration with Takeda R&D Global Compound Support QA and Quality Systems QA to identify and mitigate GCP quality and compliance issues with potential systemic impact.
- In collaboration with Supplier Quality QA, determines acceptability of vendors for potential use by Takeda R&D as well ongoing evaluation of the vendors overall compliance performance.
- Monitors and interprets compliance issues identified across clinical programs and elevates systemic problems with appropriate recommendations/solutions to senior management for immediate and long-term resolution across Takeda R&D.
- Provides appropriate risk analysis for key stakeholders to make critical decisions.
Regulatory Inspection Support
- Represents Takeda R&D during GCP regulatory inspections assuring management that responses are timely and appropriate to maintain good standing with regulatory agencies.
- Coaches and educates external sites and cross functional Takeda R&D staff in regulatory inspection readiness activities.
- Represents CQA during regulatory inspections. Assures that responses are timely and appropriate to maintain Takeda good standing with global regulatory agencies.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- B.S. in Biology, Nursing, Pharmacy, or related scientific field. MS preferred.
- Minimum 9 years of experience in the pharmaceutical or biotechnology industry with 5 years of GCP QA experience
- Minimum 5 years managing teams in a matrix team environment or managing people.
Knowledge and Skills:
- Advanced knowledge and demonstrated experience in the applicable GXP regulations, FDA Good Clinical Practices, ICH Guidelines, Global Drug Development Regulations and Guidances and Computer System Validation
- In-depth knowledge of drug development processes and GCP regulations
- Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to subject protection and data integrity.
- Demonstrated ability to effectively organize and execute tasks
- Strong verbal and written communication (including presentation) and customer management skills.
- Demonstrates proficiency in negotiation and conflict resolution.
- Computer proficiency
- ASQ Certified Quality Auditor (CQA), ASQ Certified Manager of Quality/Organizational Excellence, or SQA Registered Quality Assurance Professional preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
Takeda is a global company. Travel is a requirement of the position.
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visithttp://www.takeda.us/careers/EEO_Policy_Statement.aspx
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