*Only candidates currently living in Canada, with the legal right to work here will be considered for this position*

Are you energized by the challenge of being responsible for quality assurance activities supporting the Canadian Rx Commercial business (Importation/ Distribution)? If so, this may be the job for you!

Job Purpose

As Quality Specialist – LOC Rx, you will coordinate and support changes impacting products/processes for the Canadian Rx market, including product launches

Primary Responsibilities

• Negotiate, review, and approve Quality Agreements with supply sites,
• Manage and support the documentation repository, as required per local procedures, as the Documentation Administrator,
• Coordinate and support changes impacting products/processes for the Canadian Rx market, including product launches,
• Perform batch release activities per Health Canada Regulations for Imported / Distributed products,
• Maintain product specifications in line with registration details for Canada marketed products,
• Initiate deviation records and coordinate / conduct investigations identifying root cause and CAPA,
• Perform documentation archiving per local procedures,
• Revise and approve Quality SOPs for the Canada Rx business,

• Participate in improvement projects for Quality systems and other special projects and initiatives,

• Perform Self Inspection audits,
• Support regulatory or 3rd party audits with document preparation, control room support,
• Liaise with 3rd party customers, logistics providers, providing direction and support as required,

• Produce trending reports, KPIs on weekly / monthly basis and summarize trends,
• Perform duties of a Training Coordinator and Documentation Administrator per local procedures,

• Manage product quality complaints originating from Canadian market; review investigation reports from investigating sites; liaise with Drug Safety and Customer Service for complaints processing, trend and analyze complaints data, report conclusions and required actions,
• Retrieve, review, and summarize Periodic Product Reviews supporting Canada imported / distributed products; escalate product performance trends,
• Retrieve, review, and summarize Annual Stability Reports supporting Canada imported / distributed products; escalate out of trend and specifications results,
• Manage, support and trend training, as required per local procedures as the Training Administrator.

Why you?

Basic Qualifications:

• Bachelor of Science or Engineering degree or equivalent
• Minimum 3 years pharmaceutical industry experience (within Quality Assurance or Regulatory Affairs)
• Strong knowledge of QA systems, processes, and related regulatory requirements (cGMPs)
• Demonstrated risk-based decision-making skills
• Demonstrated proficiency in computer systems

Preferred Qualifications

• Strong understanding of the regulatory framework within Canada pertaining to Drug Products and Medical Devices
• Demonstrated results in a cross functional environment
• Excellent organizational and communication skills (verbal and written)
• Demonstrated ability to prioritize work, adapt to change, meet objectives / deadlines.
• Experience with software solutions for managing business operations for QA/GMP environments (e.g. SAP, VQMS, etc)
• Understanding of manufacturing and packaging processes, as well as supply chain, is an asset
• Ability to analyze data, trend, and determine corrective actions.

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.

Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together.

Our Pharmaceutical Supply Chain (PSC) business is responsible for making and supplying our pharmaceutical and biopharmaceutical products around the globe. The PSC organization is involved with every production stage from the infrastructure of the manufacturing sites, supply forecasting, regulatory inspections, and the product’s quality.

We operate across 28 sites in 16 countries. Over the past three years, we have become even more reliable and competitive, increasing our productivity by over 20%. We are building an agile network that delivers the next generation of medicines for patients, developing an exciting pipeline of specialty medicines and vaccines as technology transforms what is possible in pharmaceutical manufacturing. A pipeline of specialty medicines will require a different supply chain, which will demand the right capabilities and capacity. Automation and Robotics play a key role in all this, and we will increasingly have the tools at our disposal to work smarter and more efficiently.

We’re taking bold steps on inventory, productivity, and procurement to maintain a balanced scorecard and provide the cash needed to reinvest in innovation. Our ambition is to continue to advance our quality, safety, and supply standards, which enhance the trust patients, physicians, local communities, and regulators have in us.

Environmental sustainability is a vital part of our focused Environmental, Social, and Governance approach to support sustainable business performance. We’ve set new ambitious environmental sustainability goals: to be carbon net-zero and nature net positive by 2030.

• LI-GSK

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 impact the health of 2.5 billion people around the world in the next 10 years.

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 canada-recruitment@gsk.com. 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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