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Let's push the boundaries together and make the most of your talents!

Quality Lead Canada

Location: 

Toronto, Ontario, Canada

Job Function:  Quality Assurance
Job ID:  69111

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

The Quality Lead is responsible for the local Quality Management System and maintenance of the GxP status of the Canadian affiliate in accordance with national and international GxP and legal requirements, assisting in the identification and mitigation of issues and risks, and highlight improvement opportunities and facilitate the development of solutions. This person will also be responsible for final market release of commercial products according to the local requirements including final evaluation of deviations with regards to their impact on the pharmaceutical quality of drugs.

 

You will contribute by: 


•    Facilitating, implementing, and maintaining an effective and compliant Quality Management System in line with the Regional Quality strategy and according to UCB policies, corporate quality standards, global SOP’s, cGxP and applicable local regulatory requirements
•    Facilitating, implementing, and maintaining Health Canada Drug Establishment License in accordance to regulatory requirements. 
•    Ensuring efficient information flow and effective communication of all relevant quality matters within the relevant Affiliate organization, from the Territory to the Global QA organization and vice-versa including but not limited to issue escalation and communication of new regulations via the Regulatory Intelligence Network (RIN)
•    Representing the area on RQ meetings, Regional/Global Quality projects and improvement initiatives, as requested 
•    Ensuring the execution, and having the oversight, of the local Quality Management System, e.g.
o    management of complaints, deviations, change controls and CAPA according to UCB corporate SOPs and using the relevant UCB electronic systems
o    the periodic Management Review to assure consistency and compliance with UCB procedures and local regulations, and to ensure escalation to management of (potential) issues
o    management of periodic Product Quality Review, stability, OOS/OOT, master batch record documents and validation in accordance with the MAH responsibility
o    quality oversight to Local GxP Vendors in compliance with UCB Quality Standards and ENG guidance (qualification, quality agreements, vendor management, divestment). Approving any subcontracted activities impacting GDP or GMP at the affiliate.
o    establishing and adherence to self-inspection and external audit plans
o    leading local recalls and all related correspondence with national competent authorities
•    Ensuring all Quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g. follow up and closure on all relevant complaints, deviations and CAPAs, change controls)
•    Maintaining the Site Master File and/or Quality Manual, as required
•    Ensuring the establishment of a business continuity plan for Quality activities
•    Actively engage in the Affiliate Risk to Value process, collaborate with key GxP and business stakeholders to identify and assess risks, and support the local risk champion in risk mitigation activities. Together with site management provide direction, formulate strategies and make decisions which ensure efficient Quality operations and Quality risk mitigation.
•    Ensuring compliance to GDP and ensure proper shipping conditions are implemented for secondary and tertiary distribution, as applicable, driving a QA decision on the disposition of the product in case of deviations (including excursions)
•    Ensuring appropriate systems in place at the Affiliate to ensure product traceability of all product
•    Ensuring suppliers and customers of the affiliate are qualified
•    Ensuring readiness for all cGxP internal, external and regulatory inspections
•    Addressing any deficiencies identified through audits or other means by providing guidance for identification and timely implementation of appropriate corrective and preventive actions 
•    Maintaining competence in GDP and GMP through regular training
•    Ensuring that within the affiliate a local GxP training program is established and its effectiveness checked.
•    Ensuring information and documents are maintained in the appropriate UCB tools and that appropriate local archiving system are in place
•    Ensuring that the Intra-group quality agreement with Global QA and associated appendices are complete and up to date
•    Keeping records of any delegated GDP or GMP duties at the affiliate as needed
•    Ensuring compliant final disposition of returned, rejected, recalled or falsified products and authorization of return to saleable stock of any returned medicinal products
•    Ensuring any additional requirements imposed on controlled or un-licensed medicinal products by national law are adhered to
•    Ensuring that coordinated contact is maintained with the local Regulatory Authorities and the local partners (suppliers, third parties, licensees, and distributors)
•    Maintaing list of all local licenses and certificates in collaboration with RA
•    Interfacing with authorities in collaboration with RA as appropriate.

 

Interested? For this position, you’ll need the following education, experience and skills

 

Minimum Qualifications:

•    Bachelor’s degree required
•    5+ years of experience working with international GMP/GDP requirements 
•    5+ years of experience interacting with regulatory bodies and/or third-party organizations with respect to Quality systems and regulatory inspection preparedness
•    Good quality auditing mindset, root cause and risk management/assessment skills.

 

UCB Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.


Why you should apply:

Do you want to contribute in bringing real value to patients living with severe diseases while driving innovation forward? Join UCB’s dynamic, inspiring and innovative environment. You will be recognized for impactful performance via a competitive compensation and benefits package and you will enjoy ample personal development opportunities.

 

Tell us what makes you the perfect match to our team and join one of the most dynamic & forward-looking organizations in the world. 
To apply, please go to www.ucb.com/careers.  
 

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. 

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