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Commercial Quality Lead - ICMEA

Apply Now Email Me Job ID R0011826 Date posted 11/26/2019 Location: Abu Dhabi, United Arab Emirates

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Job Description

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.

ACCOUNTABILITIES

  • 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.

Leadership

  • 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. 

Interaction

  • 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

Innovation

  • Understanding of industry, scientific and regulatory trends in the region, and its market conditions and requirements.

Complexity

  • 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

             Leadership Behaviors

  • 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

Locations

ARE - United Arab Emirates Remote

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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