Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as Manager, GMP Quality Systems at our Cambridge, Massachusetts office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, GMP Quality Systemsworking on the Quality Assurance team, you will be empowered to make meaningful contributions and a typical day will include:
The Quality Systems manager is accountable for management of the quality systems, including documentation, training, deviation/OOS/CAPA, product complaint, change control and LIMS processes supporting the Takeda Vaccines Business Unit (VBU). The position requires collaboration with numerous functions within the business unit, global Takeda, as well as third party vendors and business partners.
Quality Systems works with functional management and other quality colleagues to ensure that all GxP systems are in a state of compliance and inspection readiness. Quality Systems manages the business unit s electronic Learning and Documentation Management System (DMS/LMS), including administration, as well as training and document compliance for all GxP users. Management and administration of other Quality Systems is shared across Takeda Global Quality.
The position provides key leadership in the development, design, and implementation of global and cross-functional GxP systems, and associated processes and procedures. Provides strategic direction for alignment of implementation and support strategies for quality processes and supporting technology, and ensures the integrity, consistency, and harmonization of these processes and systems across the business unit in alignment with global Takeda.
With oversight from Quality Systems management and VBU Quality leadership, provides guidance and expertise necessary to direct quality system support activities for the business unit, including but not limited to:
- Facilitate and disseminate cross-functional and regional globalization of the systems and processes that support Takeda Quality Management System (QMS)
- Provide leadership for the implementation of QMS, to including global and local procedures, and associated training content and delivery ensuring target employees have adequate training assignments
Support daily operations of VBU quality systems.
- Responsible for the overall compliance of training activities and expertise for GxP and guidance for Non-GxP audiences
- Act as primary contact and support for training and documentation related questions and issues
- Design, develop, and administer the training in support of regulated activities
- Provides key leadership by developing strategies to ensure best practices are incorporated into the development of documented procedures and specified required training (globally, cross-functionally and regionally)
- Provide direction and expertise to employees to ensure the development, management and implementation of controlled documented procedures and business critical policy and procedures with associated training
- Responsible for quality oversight of VBU GxP document lifecycle states in the DMS
- Responsible for management of VBU GxP training assessments and assignments to applicable personnel
- Coordinate quality events/processes (deviation, change control, etc) and support review board activities as applicable
- Support quality metric reporting and periodic assessment of the health of VBU quality systems
- Support the product complaint triage process to ensure compliance with procedures/processes
- Support process and technology initiatives for VBU and Takeda quality systems; participate in continuous improvement projects
- Administer training for quality systems, which may include VBU specific user training or training globally within Takeda
- Author and maintain procedures supporting quality systems maintaining compliance with regulations and Takeda policies
- Generate reports, monitor training compliance and perform tracking and trending of relevant training data. Identify and evaluate gaps and develop corrective actions to close gaps.
- Ensure new personnel have appropriate GxP training assignments and provide new hire training for applicable quality systems
Contribute to create and communicate an employment culture and values which attract, retain, and develop the most effective people
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
- Bachelor s degree in a scientific discipline with 7 years of experience and 5 years working in Quality Compliance or Systems within the pharmaceutical or related industry, including 5 years in a GMP Quality Assurance role. Experience may be substituted for a degree.
- Experience in administration and/or management of GxP documentation, training and quality event/process systems
- Must have ability to utilize knowledge and interpersonal skills to provide leadership, direction and development cross-functionally and regionally, at all organization levels
- Well organized and detail-oriented; must be able to effectively prioritize work
- Eager to learn, interact cooperatively and effectively with others in a team environment
- Possess advanced word processing, data entry and data presentation computer skills
- Excellent communication skills, both oral and written
- Experience in Labware, Trackwise, Assurx, QUMAS, NetDimensions, SAP or related systems a plus
- Ability to influence and work effectively with various business partners in multiple regions and cultures
- Strong project management skills
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Lifting and moving supplies and equipment (up to 25 pounds).
WHAT TAKEDA CAN OFFER YOU:
401(k) with company match and Annual Retirement Contribution Plan
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
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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