- Evaluates, develops, implements, and manages GMP Quality Management System (QMS) and processes which support the VBU (Vaccine Business Unit) GMP Quality Assurance organization. This role partners with global colleagues to provide leadership and ensure there is a compliant, efficient and scalable QMS throughout the VBD organization.
- Incumbent is directly responsible for QMS elements supporting the development and manufacture of biological drug substances (i.e., active pharmaceutical ingredients (APIs)) and drug products, including packaging and labeling, throughout global VBU locations.
Develop and lead quality compliance efforts for VBU through the creation and maintenance of global regulated/controlled documents such as: Quality Standards, Global SOPs, and Guidance documents and site SOPs. Collaborate effectively with VBD management in all regions to align support and approval of these documents.
Analyze, trend, and report on GMP Key Performance Indicators to senior management in VBU in order to monitor the effectiveness of processes within the quality system. Compile division-wide quality data and publish into a monthly report and a quarterly management review presented to VBD COO (Chief Operating Officer) and staff.
Direct the creation and implementation of Divisional Quality Standards, lead the assessment of site procedures against Quality Standards, and initiate changes where needed in order to ensure continued GMP compliance. Manage controlled documents through interaction with Takeda Quality Systems.
Design, implement, manage, and improve global QMS associated with GMP aspects of vaccine development such as change control, CAPA, investigations, OOS/OOT, deviations, document control and training.
Provide global leadership to VBU in the development and implementation of training strategies and training matrices to ensure personnel are appropriately trained to carry out their responsibilities.
Lead cross-regional teams in VBU process improvement initiatives through the utilization of project management skills.
Facilitate strategic development across VBU by coordinating the creation of VBU QA Key Initiatives and Mid-Range Plans. Track progress against stated plans and report on VBDUQA performance to senior management.
Interact with and influence colleagues in VBU, CMSO Quality Systems, and CMSO Quality Services in order to strategically align and facilitate harmonization of quality systems, procedures, and processes where necessary.
Manage the VBD non-medical complaint process and system utilized by VBU regional QA groups world-wide to ensure that complaints are received, investigated, and documented according to procedural requirements and regulations. Ensure a continuous state of process compliance through personnel training, monitoring support, and improvement initiatives.
Manage the CTM Recall Process to oversee the removal, recovery, or correction of Clinical Trial Materials when and if determined necessary.
Continuously survey global regulatory guidance and trends (e.g. ICH Q10 Pharmaceutical Quality System), perform gap analyses relative to VBD current state, and formulate/implement improvement initiatives.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
Minimum 10 years experience in Quality or Regulatory compliance (FDA, EMA or other) within the pharmaceutical, biologics or vaccine industry, with specific focus on developing and managing global GMP Quality Systems.
Minimum 7 years experience in GMP QA and/or QC
Experience leading and managing complex and matrix project teams and processes in a virtual organization (e.g. change control, CAPA, deviations, product complaints, management review)
Direct experience developing and assessing metrics and data, analyzing for trends, and reporting to global, senior-level management on GMP State of Compliance (Management Review).
- Experience in working with/managing GMP Quality Management Systems, documentation systems and training systems.
Behavioral Competencies and Skills:
Proven leadership, team building skills and strategic problem-solving ability. Ability to manage and lead others through change. Demonstrated ability at managing matrix teams, influencing outcomes and key project decisions
Proven ability to communicate and collaborate effectively with senior management. Experience interacting with external collaborators with ability to build strong relationships.
Knowledge of risk management, project reporting, and general project management experience/expertise required.
Strong interpersonal skills particularly motivational, negotiation, listening, judgment, and conflict management skills, demonstrated by ability to lead teams in a complex, matrixed and global environment.
Excellent organization, verbal and written communication skills to explain project goals and inspire support.
Ability to work well with cross-functional teams to accomplish objectives. Ability to work effectively in a fast paced, rapidly changing technology environment, and to work on multiple work streams and projects simultaneously.
Demonstrated analytical capabilities with the ability to analyze a wide variety of information and data to make management decisions regarding potential risks associated with regulatory compliance.
Demonstrated proficiency in MS Office applications required; proficiency in Quality Systems Databases such as TrackWise or similar systems highly desirable.
Proactiveness ability to anticipate potential problems and risks related to quality system expectations and regulatory compliance, formulate action plans, and implement solutions
- Must have a fundamental understanding of the drug development process, scientific methods and thought processes.
Requires approximately 20% travel, both domestic and international.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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Learn more at takedajobs.com.
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