Quality Manager - Middle East

By clicking the "Apply" button, I understand that my employment application
process with Takeda will commence and that the information I provide in my
application will be processed in line with Takeda's Privacy Notice and Terms
of Use. I further attest that all information I submit in my employment
application is true to the best of my knowledge.

Job Description

Are you looking for a patient-focused, innovation-driven company that will
inspire you and empower you to shine? Join us as Quality Manager - Middle
East in our Dubai, UAE office.
Here, you will be a vital contributor to our inspiring, bold mission.
PRIMARY ROLE
* Deployment of Takeda global quality management system across Middle East (ME) Cluster fulfilling applicable local laws and regulations, provide feedback to management on quality performance and quality risk management, and to support continuous improvement of our GxP activities.
* Ensures safe and effective Takeda product delivery to Takeda 's patients in ME countries through integrated and well established GxP suppliers qualification programs fulfilling Takeda quality standards and local regulations.
PRINCIPAL ACCOUNTABILITIES
* Manage GxP-regulated activities in ME Countries to ensure compliance to Takeda requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner.
* Implement Takeda QMS and ensure ongoing compliance to the quality standards and procedures at the ME. These include but are not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.
* Ensure all relevant ME colleagues performing GxP/quality-related tasks are appropriately trained prior to performing activities.
* Implement Supplier Quality Program at the ME using a lifecycle management approach which would encompass the selection & qualification of new suppliers, ongoing quality performance monitoring and exit of suppliers which provide materials and services with GxP/product quality impact.
* Establish and maintain internal and external Quality Agreements.
* Provide quality oversight of local GMP/GDP activities, e.g. local (re)labelling/(re)packaging, cold chain management, temperature excursion management, method transfers, etc.
* Perform batch releases &/or duty of care releases, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country. This includes import testing where required under local regulations.
* Review PQRs to ensure acceptability to the requirements of the market.
* Establish and lead internal audit / self-assessment program at the ME, to evaluate compliance with product quality systems & processes in ME, and to identify improvement opportunities.
* Lead regulatory inspections at the ME for GMP/GDP/Product quality related activities and ensure that regulatory commitments are duly completed on time.
* Develop and execute Annual Country Quality Plan at the ME. This will include the following:
* Establish and maintain the local risk register. Engage the key ME stakeholders to proactively identify GMP/quality risk areas, and establish appropriate risk mitigations and risk monitoring program at the ME.
* Ensure local Quality Council / Management Review is conducted on a regular basis.
* Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions.
* Main point of contact for the investigations and resolution of all product quality issues discovered or originating in the ME and for interacting with the relevant local stakeholders (such as Regulatory Affairs, Medical, BU) and GMS on such issues.
* Management of product-related complaints in the ME, and quality investigations at the LOC. Report suspect counterfeit cases and support GPP investigations.
* Drive timely implementation of CAPAs where required at the ME and verify CAPA effectiveness.
* Initiate Notification to Management / escalation report for notifiable events in accordance with Takeda Global Procedure.
* Execute local recall/market action once the decision is endorsed by Market Action Committee (MAC) and ensure timely completion of the required actions.
* Lead, or support health authority communications on Product Quality issues impacting the ME countries.
* Lead the implementation of GxP-enterprise system(s) in the ME, ensuring that CSV and data integrity requirements are met.
* Drive and strengthen the Quality Culture at the ME
* Gather local regulatory & quality intelligence. To communicate and raise awareness of upcoming and new regulations within Takeda.
* Provide quality support for product launches
* Perform customer bona fide checks, to ensure the appropriate & valid authorizations and licenses are in-place.
* Ensure responsibilities and duties of RP/QP
EDUCATIONAL, BEHAVIOURAL COMPETENCIES AND SKILLS
* University degree in Pharmaceutical Science, Pharmaceutical Technology, Microbiology, Chemistry or equivalent
* Minimum of ‎5-‎7 years in a QA/QC position in pharmaceutical industry
* Possesses appropriate quality and technical experience, and RP qualifications (latter as required under local regulations)
* Prior experience managing external GMP/GDP suppliers
* Ability to make sound and effective quality decisions under pressure
* Skilled at leading GMP/GDP audits
* Able to work independently
* Strong GMP knowledge and experience
* Familiarity with local and international GMP / GDP regulations
* Critical-thinking skills
* Adept in leading investigation and problem-solving
* Strong communication and stakeholder management skills.
* Fluent in written and spoken English.

Locations

Dubai, UAE

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time