The purpose of the Clinical Trials Quality, Senior/Principal Associate is to partner with the EMEA Trial Capabilities Team in the development and implementation of quality activities. This includes execution of quality system deliverables (e.g., deviation management, root cause investigations, and supporting CAPA implementation), providing quality oversight, supporting audit and inspection readiness and response activities, and collaborating cross-functionally to ensure compliance and drive continuous improvement.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

1. Implement and Manage Quality Systems

Contribute to the development of area-specific procedures and required tools, resource documents, and supplemental materials, including review and content approval (as assigned) of quality system documents. Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned.
Recommends 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, and 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.
Provides input into risk assessments, audit planning, and/or quality plans based on identified signals/risks/gaps.
Complete self-inspections and drive improvements that are meaningful and actionable.
Ensure local implementation of the quality systems as necessary.
Provides 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 regional and/or affiliate 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.
i. Compile compliance metrics and maintain metrics process (for example, periodic report metrics).
ii. Analyze trends, identify areas of weaknesses/gaps, and recommend corrective actions (for example, assessment reports).
iii. Monitor completion of deviations, change controls, CAPA, and 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.
Leads and/or supports 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.
Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.
Shares key learnings to drive simplification and replicate best practices.
Collaborates with other quality groups as appropriate and develops a 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.
Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.
i. Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
ii. Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of the Regulatory Quality division.
iii. 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 or healthcare-related field or equivalent work experience (e.g., Pharmacist, Nurse, or equivalent).
At least 5 years' experience working in a GCP environment.
Demonstrated experience working with medical quality systems within a regulated work environment.
Effective project and time management skills.
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:

Master's Degree.
Experience in a quality control/quality assurance role.
Experience in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management.
Ability to work independently and as part of a team.
Demonstrated ability to work in a global environment.

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