Job Title: Senior Executive – Supplier Assurance
Department: Quality
Role Holder:
Reports to: Manager – Supplier Assurance (London)

 

Main purpose of role:
The Supplier Assurance Team is responsible for the Quality related aspects of Supplier Management, ensuring Quality Technical Agreements are in place and maintained.
Ensuring Self inspection program is in place and executed, with necessary corrective and preventive actions implemented.
This role provides a good opportunity to gain exposure and knowledge of a range of functions and activities in the Pharmaceutical industry. The role requires cross-functional/departmental interaction working closely with Supply Chain, Supplier Alliance, Regulatory, Operational Projects, New Product Introduction and Quality.
Deputise for Manager- Supplier Assurance as required.
Key responsibilities (In Points):
Coordinate GMP/GDP Quality Technical agreements for approximately 400 third party manufacturers, distributors, laboratories and other GxP vendors. Ensure all elements of GMP / GDP/ MDR responsibility are correctly assigned through consultation with Supply Chain, Legal and Quality teams and ensure that scheduled review periods are assigned and met.
Liaise with the third-party GxP vendors to gain agreement and approval for the Quality Technical agreements and assist in resolving any queries.
Ensure risks associated with supplier issues are risk assessed and are appropriately classified and communicated/escalated where the continued use of the suppliers is justified.
Review and maintain the vendor master list, ensuring supplier details are up to date and in the correct status with appropriate qualification activities assigned. Liaise with other vendor master list end users to periodic review and maintain the vendor master list.
Perform change control impact assessments for quality technical agreement area on request of Manager- supplier assurance.
Support executives in the role.
Support as action owner for Due Diligence/Integrations, Pipeline and New Product Introductions.
Develop Quality Technical Agreements (or templates) in response to business requirement not fully defined by procedure.
Preparing and presenting metrics to senior leadership on behalf of the supplier assurance team.
Representing the supplier assurance team in case of external inspection or audit.
Act as deputy for Manager- Supplier assurance as required.
Prepare, communicate, maintain, manage and report GMP/GDP/MDR/GCP self-inspection annual audit program. Co-ordinate with internal lead auditors to ensure Internal auditor qualification summaries are in place, timely conduction of the audit plan, write up of reports, response from auditee received and initiation of CAPA plan.
Maintain SOP and WIs for Technical Agreements, Self-Inspection, Supplier Management and Supplier Notifications.
Assist with corrective and preventative action plans (both internally and with external suppliers).
Other activities as may be required, at the discretion of management.
Requirement Essential Desirable Qualifications:
Graduate in Science related subject or equivalent
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Experience & Competences:
Fluent in written and spoken English
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Experience of working within a Pharmaceutical company
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Experienced in the outsourcing of GxP activities in a virtual environment
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Experience of coordinating or administering processes with external
parties.
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Experience of conducting or coordinating audits or inspections
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Capable of working to deadlines
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Proven ability to organize and prioritize multiple task
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Ability to work on own initiative and juggle priorities
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Advance understanding of the GxPs / regulations associated with the role
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Ability to lead improvement projects in the area
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Ability to communicate/escalate identified issues to mitigate risk and minimize business impact
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Ability to effectively conduct investigations in subject and associated areas, identify root cause and appropriate CAPA
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Ability to work effectively as part of a team
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Experience of supporting and supervising others within a team
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Knowledge & Skills:
Requirement Essential Desirable
Knowledge of GMP and GDP requirements
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Knowledge of one of the following areas requirements; MDR, sterile manufacturing, biologics, local GxP requirements of specific countries or clinical GxP
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Strong attention to detail
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Ability to communicate effectively with internal and external customers
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Proactive nature with focus on prevention of possible issues. Sound problem-solving skills
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Excellent organization and time management skills
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Personal Qualities:
Strategic mindset, prolific communication skills, results driven, stakeholder centric focus at all times, team player and willing to take accountability
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Helpful and flexible with strong team spirit