Quality and Training Specialist
- Maintain Audit & Inspection readiness.
- Deliver and maintain the quality system to the highest level of compliance and rigor for sharing quality medical information (MI) and customer interactions.
- Subject Matter Expert for MI quality and regulatory related activities including MI service improvements.
- Liaison between Quality and Compliance functions across the organization.
- Delivery onboarding staff training and Customer Experience programs to ensure excellent customer experience, including related quality documentation management.
- Maintain the quality management system (including Standard Operating Procedures, policies and resource tools) to ensure inspection readiness for all relevant affiliates, recommending improvements where necessary.
- Maintain MI service delivery Quality Agreement(s).Determine key processes/procedures for quality controls.
- Ownership of MI quality records retention and management of documents.
- Responsible for the Self-Inspection process for Medical Information, in conjunction with the MI analysts’ and agents’ teams.
- Investigates Deviations and creates quality records or reports.
- Develops audit readiness training and awareness initiatives for organization.
- Provides support in audit/inspection backroom and/or front room including preparation, requests and close-out activities.
- Drives the closure and implementation of corrective and preventative and quality deliverables actions.
- Acts as a primary contact for documenting and updating quality reports and trackers for quality related tasks.
- Makes decisions independently, after due diligence and stakeholder consultation, and suggests alternative solutions, if necessary.
- Maintains knowledge of current competitive and European MI regulatory environment, including relevant local and regional regulations, business codes or guidance that influence or impact MI practice or processes.
- Deliver the MI related reconciliation process of adverse events or product quality complaints, creating regular reconciliation reports for Pharmacovigilance or Product Quality respectively.
- Deliver quarterly self-monitoring reports to ensure quality standards in MI request handling.
- Support cross-functional activities to resolve quality problems with solutions that translate into service improvements, liaising with the Manager, Contact Center Operations.
- Work with relevant MI stakeholders to identify service quality/efficiency/operational issues or areas of risk.
- Ensure proposed MI service improvements in processes, quality or omnichannel delivery successfully address potential compliance or regulatory conflicts through risk management.
- Provide quality and regulatory subject matter expertise for MI Europe projects to ensure regulatory compliance.
- Help resolve immediate customer problems that affect compliance. Uses professional judgement to identify underlying issues, affiliate problems and related local regulatory requirements
- Uses quality management perspective to help reduce system or organizational redundancies and inefficiencies, implementing any quality systems improvements required.
- Deliver internal and external educational programs relevant to the MI quality or regulatory issues within a contact center environment.
- Maintain and improve onboarding and brand or process updates training programs for all Medical Information Europe team members to improve customer experience, ensure compliance, increase morale and drive employee retention.
- Streamline the MI training curriculum to deliver core content for regulatory compliance whilst balancing required competency standards against the risk of lost core competencies.
- Maintain training records for all MI personnel to meet quality and compliance standards.
- Regularly assess training needs in collaboration with the team managers and leads to develop necessary training interventions (coaching, job shadow, secondment, courses etc).
- Partners with business partners, including Regional Pharmacovigilance, Regional Product Quality and Medicines Quality organization to understand quality requirements, ensure regulatory compliance and quality control management.
- Liaises with Hub Consultants or appropriate external professional organizations to maintain knowledge of local or regional regulatory or code of practice and their business relevance or impact on MI processes or compliance.
- Partners with GBS HR Learning & Development personnel to deliver required onboarding training for MI personnel.
Minimum Qualification Requirements:
- Bachelor or advanced degree in natural sciences, pharmacy or a related biomedical/clinical discipline.
- 3+ years pharmaceutical industry experience, preferably in quality, patient safety or regulatory with relevant business experience.
- Medical Information experience an advantage.
Permanent, Full Time
Additional Salary Info
- Industry Sector Science