Quality Leader (LOC Canada)

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):

• Coordinate, lead and execute quality assurance activities supporting the Canadian Rx Commercial business (Importation/ Distribution).
• Coordinate, review and approve changes impacting products/processes for the Canadian Rx market, including new product introductions
• Implements and maintains the GSK quality management system
• Review batch records and associated documentation, releasing or rejecting batches per Health Canada Regulations for Imported / Distributed products.
• Review and summarize Periodic Product Reviews; escalate product performance trends
• 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
• Revise and approve Quality SOPs for the Canadian Rx business.
• May be required to participate in Product incident events, communicate with Regulatory authorities and assist with product recalls.
• Lead or participate in improvement projects for Quality systems and other special projects and initiatives
• Act as a Subject matter expert in Quality processes, provide training as required and leadership to team members.
• 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.
• Maintain product specifications in line with registered requirements.
• Oversee product trend data, interpret data, and escalate trends as required. Present trends to commercial business teams as required

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

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

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

#LI-GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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 . Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

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