External Quality Manager

3 weeks ago

Mississauga, Canada GSK Full time

**Site Name**: Canada - Ontario - Mississauga

**Posted Date**: Mar 13 2023Are 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
- 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
- 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
- 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

LI-GSK

**_ Why GSK?_**

By 2031, we aim to deliver more than £33 billion in annual sales - a step-change in performance and growth which will significa

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