Site Name: Mississauga Milverton Drive, GSK House Posted Date: Oct 8 2024 Job posting expires on Tuesday, October 1 at 23:59 EST Are you fueled by a passion for quality, driven by a fast-paced environment, and eager to leave your mark on the world? If so, we’ve got the perfect opportunity for you Join us on our mission to deliver unparalleled products and uphold GSK's unwavering commitment to excellence. This is more than just a job—it's your chance to make a significant impact and elevate your career to new heights. Dive in with us and be part of a team that’s shaping the future with every step The role offers a hybrid work arrangement, combining remote work with in-office presence in any of: Canada, US, UK, Europe based GSK sites. POSITION PURPOSE You'll be a key player in safeguarding GSK's reputation, driving excellence through meticulous quality and regulatory conformance and compliance activities. This role offers a unique opportunity to forge strong partnerships with key contacts within External Manufacturing and close collaboration with other internal teams to ensure seamless integration and flawless execution. If you're passionate about quality, thrive in a fast-paced environment, and are eager to make a significant impact, this is the perfect role for you Join us in our mission to deliver top-notch products and uphold GSK's commitment to excellence. Primary Responsibilities Ensure regulatory conformance and compliance is managed through flow of regulatory information as governed by SOPs and Quality Agreements. Liaise with key contacts to ensure relevant and applicable outcomes from quality & manufacturing systems, such as change controls, are robust to ensure product quality and regulatory compliance. Monitor the quality performance of the systems governing third parties driving action where necessary. Monitor and assess key performance indicators, such as change controls and regulatory actions, as a mechanism to proactively propose continuous improvement initiatives or manage Quality improvement plans. Partner with Quality, Technical and Supply (PQTS) and other functions to assure that potential quality and compliance issues are identified, communicated and promptly resolved in order to assure a secure source of supply of quality product. Where required, support External Manufacturing by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions. Support, review and respond to regulatory inspections on matters that involve activities related to GSK products. Ensure timely communication of regulatory compliance and conformance topics and coordinate and track any activities related to these. Apply appropriate Risk management tools, escalating and tracking significant risks requiring resolution through appropriate corporate governance processes. Basic Qualifications: Degree in a Science or related discipline with minimum 5 years experience in a Quality oriented role Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced pharma environment. Experience in commercial focused external supply with a strong focus on regulatory conformance and compliance (i.e. change control processes) Excellent verbal and written communication skills; with strong presentation skills Ability to adapt, anticipate issues, work under ambiguity, and accommodate flexible work demands. Preferred Qualifications: Continuous improvement experience Strong Project Management skills and delivery Working knowledge of Veeva systems HYBRID 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 canada-recruitmentgsk.com. Please do not send resumes to this e-mail and instead apply through the online application process of this posting. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.