Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference.
Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives. Role Objectives: The WEP Clinical GMDP Quality Assurance Manager will be responsible for the leadership and operational execution of the site quality assurance function regarding the distribution and manufacturing (secondary packaging & labelling) activities.
They will oversee and drive day-to-day site operations, driving compliance to regulatory Good Manufacturing and Distribution Practice standards and operational improvements. The GMDP Quality Manager will also act as a primary expert and interface between supply chain and logistics, project management and other departments to drive delivery of client solutions with respects to Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.
The Ideal Candidate:
- Attention to detail
- Process-driven
- Accountable
- Collaborative
What You'll Do:
- Serve as GCP quality systems SME across global clinical operations.
- Provide QA oversight to Clinical Operations, Nursing, Project Management, Medical Affairs, Pharmacovigilance, Regulatory Affairs, and other operational teams.
- Lead investigations for non-conformances, complaints, protocol deviations, quality events, and compliance issues.
- Independently manage complex CAPAs from investigation through effectiveness checks and closure.
- Lead risk assessments for new services, processes, vendors, systems, and operational changes.
- Review clinical and GCP documentation, including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents.
- Oversee decentralized clinical trial activities, including nursing, home healthcare, source documentation, IP handling, and related processes.
- Support QMS records and documentation, including deviations, CAPAs, complaints, change controls, risk assessments, SOPs, forms, templates, and guidance documents.
- Review change controls, support approvals, and lead post-implementation effectiveness reviews.
- Support vendor qualification, audits, requalification, Quality Technical Agreements, and ongoing vendor performance monitoring.
- Support audits and inspections by managing readiness, documentation, responses, corrective action plans, evidence, and commitment tracking.
- Review quality metrics, identify trends and risks, drive improvements, support validation/qualification activities, mentor QA staff, represent Quality on cross-functional projects, escalate significant risks, and promote a culture of quality and compliance.
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- 3 to 5 years of experience in a quality-related role within a CRO, pharmaceutical, biotechnology, or healthcare organization
- Experience supporting global clinical trials and decentralized clinical trial activities
- Experience supporting Sponsor audits, regulatory inspections, internal audits, and/or supplier audits
- Practical experience with quality investigations, CAPAs, root cause analysis, quality risk assessments, and continuous improvement
- Experience with eQMS, eTMF, Microsoft Office, and quality management software applications
- Working knowledge of GCP regulations and global regulatory expectations, including ICH E6(R3), FDA, EU Clinical Trial Regulation, MHRA, GDPR where applicable, and related requirements
- Strong understanding of Quality Management Systems, risk-based quality management principles, and computerized system validation or validation lifecycle principles
- Practical understanding of GDP, warehousing, logistics, and clinical trial supply processes is advantageous
- Strong analytical, organizational, communication, stakeholder management, mentoring, and influencing skills, with the ability to manage multiple priorities, handle confidential information professionally, and apply a proactive, solutions-focused mindset