External Quality Assurance Manager
4 weeks ago
Site Name: Mississauga Milverton Drive, GSK House
Job Summary:
We are seeking a highly skilled External Quality Assurance Manager to join our team at GSK. As a key member of our quality assurance team, you will be responsible for ensuring regulatory conformance and compliance across our external manufacturing network. This is a unique opportunity to make a significant impact on our quality systems and contribute to the delivery of top-notch products.
Key Responsibilities:
- Ensure regulatory conformance and compliance through the 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 products.
- 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.
Requirements:
- 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.
Why GSK?
At GSK, we unite science, technology and talent to get ahead of disease together. We are a global biopharma company with a special purpose – to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns. 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).
We are 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.
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