Takeda Pharmaceuticals Area Commercial Quality Head in Dubai, United Arab Emirates
Provide quality oversight of GMP/GDP activities performed by local operating companies (LOC) within the NEMEA region.
Implement CMO management model within the region by applying risk-based approach, and harmonize practices across the region to be consistent with global ES quality standards and Takeda global quality requirements. Measure, analyze and influence CMO performance measures to ensure contractor and product quality performance.
Support the implementation of Takeda QMS in the LOCs, and ensure that LOC commercial quality activities are compliant with Takeda’s global quality requirements and current local regulatory expectations.
Strengthen Quality awareness and knowledge in the LOCs across the region by developing and deploying strategic quality projects and initiatives, in collaboration with LOC QA colleagues, and regional & global stakeholders.
Deliver and drive continuous improvement, collaboration and engagement across the LOC QA network, and with Regional & Global Quality teams.
Provide leadership, and technical support on Product Quality /GMP/GDP matters raised by LOCs within scope of responsibility and by contract manufacturing organization (CMOs) in the NEMEA region.
Evaluate the level of cGMP compliance and risks for products manufactured, packaged, tested and/or released by CMO(s) in the region through key performance indicators and quality performance indicators. Provide guidance to CMOs and LOCs to minimize compliance risk for products.
Ensure that contractors are periodically audited, and appropriate QA agreements are in place with the external GMP/GDSP partners.
Ensure timely resolution of quality issues, and the development of effective and sustainable CAPA plans
Actively engage with Area and Country Leadership to ensure appropriate Quality staffing is in place at LOCs to manage activities with QA/GMP/GDP impact.
Support capability-building of LOC QA colleagues to meet Takeda’s business needs.
Provide quality support for the deployment of global enterprise/electronic solutions to the LOCs as required.
Drive implementation of inspection readiness plans/pre-audit preparations with the LOCs (where applicable) to assure successful outcomes of company and external Health Authority (HA) inspections.
Be a role model for Takeda-ism and demonstrate Leadership Behaviours when dealing with internal and external partners.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Bachelor’s Degree in Chemistry, Pharmacy, Biology, or related Science discipline.
At least 12 years relevant professional working experience in pharmaceutical industry, including quality assurance, quality control or drug regulatory affairs. Familiar with cGMP/GDP, ISO and ICH requirements.
Prior experience managing CMOs is required; sterile manufacturing will be an added advantage.
Strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region.
Ability to influence and work effectively across the region and with different cultures
Strong interpersonal skills including listening, judgment, conflict management, ability to lead teams in a global environment.
Proven leadership in managing risks and resolving conflicts to achieve positive outcomes
Experience in leading GMP and GDP audits
Ability to anticipate potential problems and risks related to quality system / regulatory expectations including ability to formulate and implement solutions.
Demonstrated collaboration within and across functions, initiative and problem-solving skills.
Strong communication skills appropriate for regional and international collaborations.
Job: *Ethics & Compliance
Title: Area Commercial Quality Head
Requisition ID: 1701105