Quality Leader (Loc Canada)

Site Name: Canada - Ontario - Mississauga
Posted Date: Jul 21 2023
Are you energized by the challenge of providing leadership and working on improvement projects? This could be the job for you!
Job Purpose:
As a Quality Leader, you will provide quality technical leadership for investigations or major quality initiatives/ improvement products and/or provide supervision and leadership of quality staff
Details (Your Responsibilities):

• Act as a Subject matter expert in Quality processes, provide training as required and leadership to team members.
• Coordinate, lead and execute quality assurance activities supporting the Canadian Rx Commercial business (Importation/ Distribution).
• Review batch records and associated documentation, releasing or rejecting batches per Health Canada Regulations for Imported / Distributed products.
• Lead or participate in improvement projects for Quality systems and other special projects and initiatives
• Participate in all types of inspections including roles such as audit preparation, hosting, audit room support, performing audits. Liaise with 3rd party customers, logistics providers, providing support, direction and oversight as required.
• May be required to participate in Product incident events, communicate with Regulatory authorities and assist with product recalls.
• Revise and approve Quality SOPs for the Canadian Rx business.
• Oversee product trend data, interpret data, and escalate trends as required. Present trends to commercial business teams as required
• Review and summarize Periodic Product Reviews; escalate product performance trends
• Coordinate, review and approve changes impacting products/processes for the Canadian Rx market, including new product introductions
• Maintain product specifications in line with registered requirements.
• Implements and maintains the GSK quality management system
• Lead or participate in investigations of complaints, deviations and product incidents ensuring that all investigations are thorough, complete, identify root cause and assign appropriate CAPAs

Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

• Minimum 3 years leadership skills
• Demonstrated risk-based decision-making skills
• Strong knowledge of QA systems, processes, and related regulatory requirements (cGMPs)
• Minimum 5 years pharmaceutical industry experience
• Demonstrated proficiency in computer systems. Expertise in multiple SAP transactions is required
• Bachelor of Science or Engineering degree or equivalent
• Understanding of manufacturing and packaging processes, as well as supply chain an asset

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

• “Can do” attitude and improvement mindset
• Excellent organizational and communication skills (verbal and written)
• Ability to work alone and in cross functional teams
• Ability to take a complex problem and drive a solution with minimal direction
• Demonstrated ability to prioritize work, adapt to change, meet objective / deadlines.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
GSK is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals to apply to our career opportunities. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected]. Please do not send resumes to this e-mail and instead apply through the online application process of this posting.
As a health and science-based organization, GSK is committed to following the recommendations as set out by Health Canada and taking all necessary steps to help curb the spread of COVID-19 which includes getting the COVID-19 vaccine. We feel strongly that this is the best way to help protect those we value most: our employees, families, communities and the patients and consumers we serve. To that end, we are taking an important step to ensure the safety of our employees during this global public health crisis.
Only employees who are fully vaccinated against COVID-19 may attend our Mississauga and Laval corporate offices. In addition, all customer-facing employees who, as part of their job, attend healthcare settings such as hospitals, pharmacies, doctors’ offices and dentists’ offices will need to be fully vaccinated against COVID-19. Notwithstanding the foregoing, employees may seek an accommodation for human rights-related reasons, including medical or disability-related conditions, or religious beliefs.
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