The Role

Leadership and functional management of suppliers and their performance in alignment with GCP and applicable regulations. Management of subcontractor management plans. Responsible for overseeing the site’s Supplier Approval process and assuring its continued compliance with applicable global regulations, standards, and global company policies and procedures. Build and maintain strategic partnerships with suppliers through the supplier governance framework. Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role. Ownership of planning and execution of supplier audits related to clinical projects. Responsible for management of vendor findings to ensure timely responses are provided. Supporting the provision and development of efficient and effective Quality Assurance (QA) systems for clinical and scientific research studies Serves as a QA resource to provide input and guidance to cross-function teams on supplier quality issues and conduc t peer review of documentation, as necessary. Interprets and provide guidance, coaching, and mentoring to other functions and, where necessary, to customers on supplier regulatory requirements and expectations. Responsible for Reviewing all QMS documentation associated with equipment and the quality management of external Suppliers Documentation for Maintenance, Service and Calibration. Responsible for the archiving process of study/non-study documentation for the site. Ensure that data is stored in accordance with regulations and in a manner that always prevents deterioration or loss. To comply and adhere to GCP guidelines and regulations as required of this role.

Main tasks and responsibilities

Management of Supplier Key Performance Indicators, supplier licensure and accreditation, data trending and service relationships. Provide strategic and practical management of selection of to ensure continued compliance with the required regulatory standards. Perform vendor audits and assessments covering a wide range of suppliers and subcontractors that provide clinical laboratory testing services, clinical trial material, IT services, and other GxP related products and services. Assure supplier audits are conducted by qualified individuals per company requirements to support business goals.  Authors and Negotiates Customer and Supplier Quality Agreements in collaboration with QA management. Influence peers through routine communication and interactions to ensure compliance with internal SOPs and regulatory requirements. Participate in SCAR investigations for quality issues.  Assure that root cause(s) are identified, and effective corrective actions are implemented in a timely manner for risk mitigation. Initiates and/or maintains a supplier quality assessment and approval programme in accordance with Supplier Selection, Qualification, and Approval Policy. As needed, supports audits to monitor compliance of internal operations with internal procedures and regulatory requirements (GCP), including regulatory, site internal audits, and customer inspections. Assists on preparing supporting documentation and data for these events. Accountable for the management and oversight of the site archiving processes. Production and maintenance of the site Electronic Archiving system. Responsible for the Site electronic archiving process. Ensures records are controlled, protected, backed up (electronic) and maintained to ensure their validity and integrity throughout their lifecycle (paper or electronic). Ensures that records submitted for archiving correspond to the description (paper or electronic) and that orderly storage and retrieval of records is facilitated/indexed (paper or electronic). Ensures proper transfer and tracking of on-site archived boxes and data to long term storage supplier. Controls and provides authorized access to the paper/electronic archive and archived records. Responsible for oversight of record retrieval/return process. Ensures that records are properly disposed once they have been retained for their required lifetime in accordance with customer agreement and applicable regulatory requirements. Perform other duties as required

The Candidate

Bachelor’s Degree in a scientific field or related. Minimum 2 years relevant experience and knowledge of supplier selection, approval and management processes within a GXP regulated environment. Experience of managing change and implementing systems and procedures across the company. Competent in the use of Microsoft Office packages including Word, Excel, and other systems like eQMS, eQDocs and eDCS Previous experience of working in a clinical research environment or equivalent experience in another role. Knowledge of the regulatory framework around clinical trials and GCP Detail oriented with excellent problem solving and organizational skills. Ability to perform multiple tasks and prioritize work to assure business and compliance objectives are met.

Job Demands

The job may involve the following:

Very high concentration of work Strict and tight deadlines Having to juggle a range of tasks/issues simultaneously Working outside normal working hours Needing to respond to client requests in a timely manner