Senior Quality Assurance Specialist

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Job Description

OBJECTIVES/PURPOSE

• Support the achievement of business success with regards to GMP and quality related activities in the Canada LOC. As a key member of Takeda Canada QA department, contribute to ensure that Takeda Canada is compliant with local GMP and GDP requirements for Medicinal Products and Medical Devices.

• Responsibilities cover GxP-regulated activities including in-country disposition, distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing / packaging / analytical testing quality oversight, and medical device activities.

• Work in collaboration with other GxP and non-GxP functions focusing on patient’s needs, regulatory compliance, as well as internal standards and SOPs and continuous improvement.

• Key stakeholders support in the Canada LOC on quality matters and initiatives. Contribute to the achievement of business success.

• Supports a consistent and harmonized quality approach across the Canada LOC, including R&D QMS maintenance.

ACCOUNTABILITIES

• As a key member of Takeda Canada QA department, contribute to ensure that LOC is compliant with local GMP and GDP requirements for Medicinal Products (mainly biologics) and Medical Devices. Contribute to prepare for, host and respond to External and Internal inspections.

• Responsible for the compilation of annual Health Canada submissions in support of Takeda’s Medical Device Establishment License. Ensure that the licence remain current to support the importation and distribution of products.

• Accountable for timely product disposition, while assuring product quality and compliance. Reviews and approve PQRs for responsible products. Provide support for launching of new products in Canada: create list of documents needed for release, update/ create quality agreements, initiate CCs, liaise with RA, manufacturing, release & packaging sites for gathering all documents in alignment with HC requirements. Collaborate and participate in launch planning team.

• Support the effective implementation of Takeda Canada Quality Systems: own local SOPs, and work on CAPA, Deviations, Complaints and Change Controls.

• Establish relationship and work collaboratively to resolve quality issues with Contract Distributors (CDOs), Distributor partners, Contract laboratories and Customers. Participate to establish Internal and External Quality Agreement as directed by the QA Director. Participate and support audits and self-inspections.

• Ensure there is quality oversight of local GVP/Devices/Medical related activities, such as for local studies (e.g., Investigator Initiated Trials (IITs), Collaborative studies, Interventional studies (NI), Non-Interventional Studies (NIS) & activities impacting the PV system, e.g PV, Regulatory Affairs activities.

• Provide Quality support to the local operation, for both the existing business and the new product launches.

• Demonstrate digital fluency by effectively navigating and utilizing digital tools to enhance productivity and efficiency.

• Review and approve all data generated in accordance with current Canadian GMP Regulations.

• Provide technical support globally to external suppliers in order to ensure Takeda's commercial products are manufactured in compliance of GMPs.  

• Support and assist in coordinating Global Commercial Quality activities in compliance with local regulations and Takeda Quality Management System.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Strong knowledge of the regulations in the Geographic Scope.

• Deep understanding of LOC/Commercial Quality requirements, including in-country disposition, distribution, controlled substance compliance, supply chain quality, and local quality surveillance (returns, recalls, complaints, deviations), and contract manufacturing quality oversight.

• Meet other Legal local requirements for being Qualified Person and delegate for Medical Device Establishment Licence.

Leadership

• Ability to collaborate and partner well locally, within Canada Quality Team & cross-functionally with stakeholders.

• Ability to drive change by influence.

• Strategic enterprise thinking, finding innovative ways to serve patients, build reputation and trust.

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 Health Authority communications in the region once the decision had been aligned. 

Interaction

• Key interactions with LOC QA, Supply Chain, RA PV and Medical Affairs colleagues to improve performance & maintain compliance.

• Key interactions with key stakeholder groups including Regulatory Affairs and Drug Safety to stay abreast with business and LOC strategy and respond promptly to evolving business needs.

Innovation

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

Complexity

Regulatory framework and medical device requirements, and a wide diversity of products. Understanding of regulatory affairs registration maintenance.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Science degree (BSc)

• 5 years on job experience in Pharmaceutical company in QA environment.

• Experience and proven track record in quality assurance and deep understanding of Canada laws, regulations and Industry codes related to QA.

• Experience of working in a matrix management environment.

• Fluent in written and spoken English.

Core Competencies / Skills

• Critical Thinking

• Investigation and problem solving

• Good communication and stakeholder management skills

• Ability to manage complexity & balance priorities.

• Risk identification, evaluation, and management.

• Continuous improvement

Leadership Behaviors

• Enhanced enterprise thinking, finding innovative ways to serve patients build reputation and trust.

• Creating an environment that inspires and enables people.

• Focusing on the few priorities and provide superior results.

• Elevating capabilities for now and the future.

ADDITIONAL INFORMATION

Travel across LOC as needed, USA and EU countries (for training if needed)

Takeda Canada encourages applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial accessibility legislation, please advise us if you need accommodation in order to participate in the recruitment process. Any information you provide relating to accommodation will be addressed confidentially.

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