Role Objectives: The Clinical Quality Assurance Associate supports the day-to-day management of GCP-related items within the Quality Management System (QMS) across all clinical activities, including decentralised clinical trials (DCTs) involving nursing services and in-home patient care. This role ensures that all clinical and nursing operations are conducted in accordance with ICH GCP, applicable regulatory requirements, and internal SOPs.
The Ideal Candidate:
- Proactive and solutions-driven
- Critical thinker
- Cross-functional collaborator
- Adaptable
What You'll Do:
- Ensure GCP compliance and promote best practices across all regulated activities.
- Initiate and contribute to deviations, complaints, CAPAs, risk assessments, and validation protocols.
- Investigate deviations and complaints, and follow up on CAPAs to ensure timely resolution.
- Review clinical trial documents (e.g., protocols, ICFs, eCRFs) and essential records for accuracy.
- Review eTMF for completeness and accuracy, working with staff to resolve any deficiencies.
- Support clinical and nursing operations in managing QMS records, including change controls and risk management.
- Identify root causes of quality issues and recommend appropriate solutions.
- Assisted staff in training on QMS components and relevant procedures.
- Provide daily support on quality-related queries and maintain GxP documentation.
- Support vendor qualification and requalification, including audit preparation and participation.
- Contribute to internal audits and regulatory inspections as a subject matter expert.
- Generate quality metrics, analyse trends, and support process improvements and validation strategies.
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 0-3 years of experience in a Quality-related role, with practical exposure to GCP activities.
- Familiarity with eTMFs (e.g., Veeva Vault) and proficiency in Microsoft Office.
- Strong organisational skills with keen attention to detail.
- Knowledge of ICH GCP guidelines and relevant regulatory requirements (e.g., FDA).
- Effective verbal and written communication skills.
- Self-motivated and proactive, with strong interpersonal and critical thinking skills.
- Able to manage multiple tasks and deadlines with accuracy.
- Discreet and trustworthy with confidential information.
- Experienced in cross-functional collaboration for investigations, root cause analysis, and process improvement.
What sets us apart:WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
We're Committed to Our Team:WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.
We're Committed to DEI:At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone's unique identities.
Our services include:Access Programs Clinical Trial ServicesPatient Site SolutionsClinical Trial SupplyMarket Access and Commercialisation
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
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