Sr. Associate/Principal Associate

Purpose
The purpose of the Senior Associate/Principal Associate – Pharmacovigilance Global Medicines Quality Organisation (GMQO) representative is to support the development and implementation of quality systems and activities to support business goals and objectives.
This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas.
This Quality role will support the Global Patient Safety team ensure the benefits and risks of a medication are continuously monitored and well-understood by regulators, health care providers and patients.
This involves quality management oversight of collection, monitoring, evaluation and communication of safety information.
An element of this Quality role will also provide Business Quality Assurance support to projects, ensuring Quality is built into automation and innovation.
Primary Responsibilities
The following list summarizes general responsibilities for the role:
1. Implement and Manage Quality Systems
Contribute to the development of Global Patient Safety procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents.
Recommend new quality system documents or changes to existing quality system documents where applicable.
Advise on appropriate training for implementation and documentation.
Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
Provide input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
Complete self-inspections and drive improvements that are meaningful and actionable.
Ensure local implementation of the quality systems as necessary.
Provide support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
2. Provide Quality Oversight for business area(s)
Monitor for compliance to quality system documents.
Anticipates gaps and proactively proposes solutions.
Communicates and escalates to management as appropriate.
Ensure implementation of Quality Plan(s) as necessary.
Monitor progress of actions.
Provide updates to quality and business owners.
Seek and implement simplification and process improvement.
Coordinate quality improvement initiatives.
Review metrics and trending to improve processes and compliance, as assigned.
Compile compliance metrics and maintain metrics.
Analyze trends, identify areas of weaknesses/gaps and recommend corrective actions.
Monitor completion of deviations, change controls, CAPA, audit responses.
3. Audits and Inspections
Provide support for audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions).
Ensure completion of audit corrective action plans and timely resolution.
Lead and/or support readiness activities in collaboration with business partners.
4. Partnership with other area(s)
Functions as the initial point of consultation for business areas on quality related questions.
Partner with the business area(s) to strengthen and ensure appropriate quality controls are in place.
Share key learning to drive simplification and replicate best practices.
Collaborates with other quality groups as appropriate and develops quality network.
Establishes good working relationships with assigned business area(s).
Actively participates in team, business and quality related meetings.
Supports issue resolution including escalation.
Utilize a risk-based approach in guiding business areas.
Support key projects as assigned.
Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.
Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.
Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.
Minimum Qualification Requirements
Bachelor's Degree in a science/health care related field or equivalent work experience
Demonstrated ability to apply quality systems within a regulated work environment
Effective project and time management skills
Knowledge of GCP, ICH, FDA and other regulatory requirements
Demonstrated ability to communicate effectively, both written and verbal, and to influence others
Demonstrated ability to prioritize and handle multiple concurrent tasks
Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
Strong interpersonal skills with demonstrated flexibility in varying environments/geographies
Effective organization/self-management skills
Other Information/Additional Preferences
Minimum of three years' experience in clinical trials and/or pharmacovigilance
Strong understanding of pharmacovigilance regulations and guidelines
Proficiency in pharmacovigilance software and databases
Expertise in a quality control/quality assurance role
Experience in defined functional business areas, for example safety management
Knowledge of quality systems
Ability to work independently and as part of a team
Demonstrated ability to work in a global environment
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