* The job is located in Mississauga, Ontario, so there is a strong preference to having the candidate living in this vicinity.

Are you excited by a job that maintains working relationships with the key contacts with CMOs and Suppliers? This will include Quality, Regulatory, Business Development, Production, Site Management and others!

Job Purpose:

This position is responsible for the Quality oversight of activities carried out by External Contract Manufacturing Organizations (CMO) or Suppliers of tolled materials for established and/or new product introductions (NPI) to ensure GSK’s product quality, compliance and reputation is protected. 

Details (Your Responsibilities):

• Lead Quality Agreement negotiations with External CMO or Suppliers of tolled materials and implement Quality Systems performance management with appropriate KPIs based on contractual parameters

• Ensure regulatory compliance is managed through flow of regulatory information to and from the releasing Sites as governed by Quality Agreements. 

• Monitor the quality performance of the CMO or Suppliers of tolled materials driving action where necessary.

• Monitor and assess key performance indicators, such as complaints and deviations as a mechanism to proactively propose continuous improvement initiatives

• Apply appropriate Risk management tools with each CMO or supplier, escalating and tracking significant risks requiring resolution, including Risk Management System (RMS) reporting to Quality Council, Local Incident Committee & Product incident Review Committee (LIC, PIRC) or other corporate governance processes, as required to drive routine GEMBA with purpose as defined in the GEMBA Plan in order to assess the CMO on the shop floor

• Partner with CMOs , Quality, Technical and Supply (PQTS+) 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

• Partner with appropriate network change project teams to ensure that quality deliverables (approve significant documentation such as validation, procedures, etc.) are met in alignment with the business initiative/GSK strategic priorities

• Liaise with key contacts at the CMO or Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality and regulatory compliance.

• Provide specific GMP training for contractors, where deemed necessary

• Drive periodic review of Quality Systems at the CMOs, to complement audit processes. Where required, support the CMO by conducting GEMBAs and root cause analysis reviews for investigation of issues and development of remedial actions

• Evaluate effectiveness of the CMOs Quality Unit and systems and influence promoting robust systems operating under self-sufficient organizations

• Escalate serious cGMP/Regulatory compliance issues following internal procedures.

• Support efforts that positively influence regulators on scientific and technical matters which impact GSK and ensure that regulatory intelligence is promptly distributed for incorporation in local action plans

• Actively participate on the External Supply Quality Review Meetings, identifying Quality related issues and continuous improvement opportunities, with proposals to address these

• Support, review and respond to regulatory inspections on matters that involve activities related to GSK products

• Assess impact of inspections and responses to Regulatory observations prior to submission to the associated agency

• Work with CMOs to establish effective CAPAs, in response to GSK audit observations and ensure the Suppliers manage these to acceptable closure

• Ensure timely communication of Quality Alert issues. Coordinate and track any continuous improvement / Quality Plans deemed necessary

• Support or lead internal/external audit processes where required

• Support or in some regions provide on time disposition of finished product or tolled materials as required by Quality agreement or SOP requirements

 Why you?

Basic Qualifications:

• Degree in a Science or related discipline with minimum 5 years’ experience in various Technical and Operational Quality roles

• Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment

• Strong interpersonal and negotiation skills; with demonstrated ability to influence stakeholders

• Change Management experience

• Continuous improvement exposure

• Strong Project Management skills and delivery

• Demonstrated ability to be assertive

• Demonstrated sense of urgency

• Breadth in quality systems principles and practical application

• Good knowledge and demonstrated application of quality and risk management principles and tools

• Demonstrated sound decision-making process; based on facts & data, and application of Risk Management principles

• Technical knowledge of multiple dosage forms

• Demonstrated ability to effectively multi-task

• Excellent verbal and written communication skills; with strong presentation skills

• Strong problem-solving skills

• Demonstrated ability to work independently, but also collaborate in cross-functional teams

• Excellent written and spoken language skills

• Demonstrated commercial acumen to effectively work with external companies

• Ability to adapt, anticipate issues, work under uncertainty and accommodate flexible work demands

Preferred Qualifications:

• Previous assignment experience promoting or requiring regional perspective desirable

• Commercial Pharma experience

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 [email protected].  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.