Associate Director, GRA QMS Quality
Company: Takeda Pharmaceutical
Posted on: January 24, 2023
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The Associate Director GRA QMS Quality is responsible for the
strategic and operational activities pertaining to Global QMS
Quality elements (Deviations, CAPA, Change Control) and initiatives
and within Global Regulatory Affairs. He/she ensures alignment with
global strategic initiatives related to regulatory quality and
compliance. Develop a Quality Risk Management Program designed to
assure minimal risk is assumed while aligning to key learning
Principal responsibilities include but are not limited to:
- Development and leadership of the following activities at a
global level in collaboration with Head of GRA Compliance QMS:
- Lead the GRA support and oversight of Deviations, CAPAs and
Change Control partnering with the GRA functions (Labeling, CMC,
Operations, TAU), Quality R&D and Global Quality.
- Responsible for strategic Quality and Risk Management
initiatives and activities, leading the development of a risk
management process to prioritize and support continuous
improvement, change interventions which support QMS/Compliance and
- Responsible leading the development and evolution of a "Quality
Culture" within GRA, including follow up on audits and inspections,
driving mitigation strategies and organizational performance.
- Lead GRA performance improvement initiatives through process
and human performance improvement, identifying learning
interventions, and enabling organizational and regulatory
- Lead GRA Quality efforts, developing process, structure, and
tools that ensure communications are comprehensive across GRA,
including LOCs, and Partners as required.
- Drive the overall evaluation and effectiveness of quality
processes and systems throughout the global regulatory organization
and its partners through:
- Metrics Management & improvement recommendations
- QMS process & systems effectiveness
- Evolve Process Owner concept (define overall processes)
- Quality & Risk Management - program development across GRA
- Continuous Improvement
- Audit and Inspection support
- Drive organizational improvement in partnership with GRA
Leadership, and its functions.
- GRA Non GxP records Mgt. (CV/BOPs/Non GxP Docs/forms)
- GRA Data Analysis - QMS
- R&D Quality and Global Quality partnership and
- Establish & Lead GRA SME Network
- Actively represent GRA as QMS Governance SME
- Develop and sustain structure of GRA Compliance QMS ensuring
connectivity and compliance within LOCs.
- Employ appropriate methodologies for implementing QMS processes
across GRA and its partners (ie. LOC RA and partners).
- Leads the development of a Quality Risk Management program for
GRA projects. Applying pre-determined risk measures to GRA
processes and procedures to mitigate risk and continuously improve
- Leads the monitoring, interpretation, and communication of
regulatory QMS processes and metrics requirements including
- Partners to develop relevant GRA metrics to track key QMS and
compliance initiatives, including partnering with cross-functional
Takeda partners and LOCs on strategic initiatives and planning,
then communicates issues/trends to GRA leadership.
- Ensures all inspection and audit questions or findings related
to GRA QMS are addressed appropriately.
- Supports LOCs inspections/audits relating to GRA QMS
- Responsible for GRA QMS related corrective and preventative
action plans (CAPAs).
- Program Management and dashboarding:
- Lead the ongoing management and continuous improvement of QMS
tools (and dashboards) that support learning, documentation
processing, non-conformance program, and CAPA management
- Provide input on training requirements related to GRA overall
- Escalate issues/problems to senior management as needed
- Provides input on budgets for the group as appropriate.
- Maintains strong knowledge of current regulations, legislation,
best practices and guidelines relating to Regulatory Affairs as
well as GxP Learning and Quality Risk Management (QRM).
- Represents Takeda at relevant Industry Forums e.g. GMPTEA,
AGxPE EDUCATION AND EXPERIENCE REQUIRED:
- 7-10 years and a proven track record with Quality management,
organizational development, quality risk management, and learning
initiatives, including organization design. Able to design,
implement and achieve expected results from these initiatives
- Bachelor's degree (or equivalent) required. Masters
- Substantial experience in Pharmaceutical industry, with good
exposure to Regulatory Affairs, research and development and
quality assurance / compliance.
- Familiarity with inspections and audit procedures and risk
- Strong knowledge of business area and interactions with strong
regulatory environment and ability to identify and proactively the
interactions necessary for achieving business goals and
- Ability to identify proactively and anticipate risk of
non-compliance in a complex environment
- Practical operational experience of working across disciplines
and across multiple regions. Experience working within a global
team framework and a multi-cultural environment.
- Acts as a positive change agent and is highly adaptable to
changes in the work environment; manages competing priorities and
- Strong learning and development orientation and mindset
including facilitation, content development, organizational
diagnosis and measurement, driven to grow and develop self and
- Excellent interpersonal, communication (written and verbal),
and advanced presentation and facilitation skills
- Excellent meeting management skills, including design,
preparation and facilitation
- Excellent organization, time management and project management
skills, able to balance multiple projects and initiatives Skills
and Knowledge Desired:
- Systems Knowledge - extensive knowledge of Quality Management
Systems, including eDMS, Deviation (Trackwise), LMS systems and QRM
(Quality Risk Management)
- Regulatory Familiarity - extensive knowledge of European, US
and international regulations relative to activities covered in
- Industry Knowledge - strong understanding of the pharmaceutical
industry and pharmaceutical companies' operations processes and
strategies including Regulatory Affairs processes.
- Takeda Operations - in-depth understanding of Takeda's
operating philosophy, structure and methods including a thorough
knowledge of the foreign owned parent company and any affiliates.
Ability to work effectively with any internal and external Takeda
- Analytical Skills - ability to identify the critical issues of
problems or opportunities using appropriate information; determines
the causes and possible solutions to the problem.
- Communication - ability to express oneself clearly and
concisely to a variety of audiences. Ability to
understand/analyze/synthesize and communicate to internal/external
- Team Working - Ability to work with team members in a friendly,
professional manner. Motivate and empower others. Manage teams to
work productively in a high pressure environment
- Knowledge Sharing - ability to capture knowledge within (and
from outside) the organization; offer solutions, improve processes
and deliverables through use of information; improves information
capital by contributing experience, deliverables and models for
others to use.
- Interpersonal Flexibility - ability to adapt to other
personalities in a respectful manner that is conducive to goal
- Must be able to lead cross-functional and cross regional teams
and deliver results in a matrix organization. Excellent
organizational skills and ability to prioritize.
- Project Management abilities LICENSES/CERTIFICATIONS:
- ASQ Manager of Quality Organizational Excellence
- ASQ Pharmaceutical GMP Professional
- RAPS Regulatory Affairs Certification (RAC) TRAVEL
- 10%, some international required. ADDITIONAL US SPECIFIC
INFORMATION (FOR US RECRUITMENT ONLY):
- Bachelor's degree (or equivalent) required. Masters
- 7 + years experience in Pharmaceutical industry, with 5 years
in Regulatory Affairs, research and development or quality
- A minimum of 3 years of QMS experience. Experience in the
development, implementation and maintenance of a QMS as well as GxP
and QRM. EEO Statement
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 . click
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Keywords: Takeda Pharmaceutical, Clifton , Associate Director, GRA QMS Quality, Executive , Clifton, New Jersey
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