OBJECTIVES / PURPOSE
• This role performs a direct quality oversight of LOCs in ICMEA region.
• Responsibilities cover in-country distribution quality, local quality surveillance and local contract manufacturing/packaging quality oversight.
• This role drives the alignment of the strategies wih the Quality Roadmap, and builds quality capability of the LOCs.
• Provide technical guidance and expertise to LOCs on quality matters.
• Drive timely resolution for quality matters in the LOCs and support escalation/communication within Takeda.
• Execute initiatives to drive sustainability and compliance to Takeda QMS and local regulatory requirement in LOCs. Monitor compliance sustainability and performance.
• Lead the implementation of quality improvement programs, risk management programs and compliance education initiatives in the region.
• Lead the regulatory surveillance & intelligence in region for new or emerging regulations.
• Identify areas of opportunities in the region for quality capability building and lead the initiatives to strengthen the quality decision making.
• Drive the implementation of continuous improvement initiatives and implementation of best practices for quality and compliance related areas across the region.
• Provide guidance and support inspection readiness of LOCs in the region.
DIMENSIONS & ASPECTS
Technical/Functional (Line) Expertise
• Strong knowledge of regulations pertaining to pharmaceutical manufacturing, quality assurance and distribution in the region.
• Understanding of LOC/Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (re-turns, recalls, complaints), and contract manufacturing quality oversight.
• Ability to collaborate and partner well regionally & cross-functionally with stake-holder groups
• Ability to drive change by influence
Decision-making and Autonomy
• Responsible to anticipate potential problems and risks related to quality system / regulatory expectations and implement solutions.
• Responsible for timely execution of market actions and HA communications in the region once the decision had been aligned.
• Key interactions with LOC QA colleagues in region to improve performance & maintain compliance
• Key interactions with regional business, e.g. GMS/GSC to stay abreast of business and network strategy.
• Key interactions across manufacturing and Quality regional and operating unit teams to enable timely issue resolution
• Understanding of industry, scientific and regulatory trends in the region, and its market conditions and requirements.
• Multiple countries, supply & distribution models covering high number of Wholesaler Distribution Authorizations, regulatory frameworks and a wide diversity of products.
EDUCATION, BEHAVIOURAL COMPETENCIES & SKILLS
• Scientific degree (BSc, MSc)
• >10 years of increasing management responsibility in the pharmaceutical industry including Quality Assurance, combined with a strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements).
• In-depth knowledge of global pharmaceutical operations, supply chain / distribution management, CMO management, Quality.
• Strong interpersonal skills including conflict management.
• Ability to work in an international environment cross functional with remote teams and stakeholders
• Experience include successful examples of managing and leading by influence - without direct resource control.
• Previous regional quality experience and/or Commercial Quality experience is preferred.
• Fluent in written and spoken English.
Core Competencies / Skills
• Critical Thinking
• Investigation and problem solving
• Strong communication skills
• Ability to influence and work effectively across the region and with different cultures
• Risk identification, evaluation and management
• Continuous improvement
• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust
• Creating the environment that inspires and enables people
• Focusing on the few priorities and provide superior results
• Elevating capabilities for now and the future
• Takes an optimistic and constructive stance when challenges arise and driving solutions
ARE - United Arab Emirates Remote