Senior GMDP Quality Assurance Manager

WEP Clinical•Morrisville, NC

88d•Onsite

About The Position

WEP Clinical is seeking a Senior GMDP Quality Assurance Manager to provide senior leadership and accountability for the site quality assurance function supporting distribution and manufacturing activities, including secondary packaging and labelling. The role will oversee day-to-day site quality operations, ensure continued compliance with regulatory Good Manufacturing and Distribution Practice standards, and drive effective, risk-based decisions and operational improvements. The Senior GMDP Quality Assurance Manager will act as a senior quality subject matter expert and escalation point, partnering with supply chain and logistics, project management and other departments to enable compliant delivery of client solutions across Post Approval Named Patient/Expanded Access Program and Clinical Trial supply service lines for the site.

Requirements

Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
7+ years of relevant pharmaceutical or life sciences quality assurance experience, including substantial responsibility within both GMP and GDP operations
Proven senior leadership and people management capability, with experience setting direction, influencing cross-functional stakeholders and making sound quality decisions in complex or time-critical situations
Experience with UK, FDA, and EU regulations related to manufacturing and distribution operations
Extensive applied knowledge of GMP and GDP, including data integrity, label control, secondary packaging, risk-based quality management, deviations, change control, supplier/customer management, and QMS processes
Experience reviewing and approving deviations related to secondary packaging activities
Strong ability to make independent, risk-based decisions while balancing business needs and quality requirements
Highly organized and able to manage multiple priorities to strict deadlines with accuracy, adaptability, and sound judgment under pressure
Strong communication and stakeholder management skills, with the ability to explain complex quality issues to quality and non-quality personnel
Ability to support cross-functional projects, investigations, root cause analysis, process improvements, QMS/business process development, and proactive escalation of quality, business, or client-related risks
IT literate, including Microsoft Outlook, Word, and Excel
Willing to be on-site 5 days a week, if required

Nice To Haves

Attention to detail
Proactive and self-motivated
Calm and logical under pressure
Strong leadership mindset

Responsibilities

Accountable for day-to-day site quality operations, ensuring critical quality records and activities are completed on time while protecting patient safety and product quality.
Lead the effective operation and continual improvement of the site Quality Management System, ensuring compliance with GDP/GMP, procedural standards, and applicable regulatory requirements.
Own and report site quality performance indicators, identify trends and systemic risks, and drive timely, data-led corrective and improvement actions.
Provide hands-on quality oversight of warehouse distribution, manufacturing, secondary packaging, and related supply chain/logistics activities.
Complete or oversee risk assessments, support compliant decision-making, and act as the escalation point for site-specific quality issues or GxP-critical events.
Ensure timely and effective completion of quality records, including deviations, complaints, CAPAs, change controls, customer verification, investigations, and root cause analyses.
Oversee secondary packaging quality activities, including packaging strategy, specification review/approval, executed batch record review, QA oversight, and product disposition.
Complete critical warehouse reviews as Responsible Person, Deputy Responsible Person, or Equivalent Delegate, including maintenance, pest control, cleaning, calibration, and related records.
Partner with EU/UK Qualified Persons on communications, GMP queries, batch certification activities, and associated processes where applicable.
Lead site inspection readiness, self-inspections, client audits, regulatory inspections, audit responses, CAPAs, and sustained remediation of findings.
Lead, coach, develop, and line manage the QA site operations team, including resourcing, capability, succession planning, training, performance feedback, and technical development.
Provide quality leadership for client communications, Quality Technical Agreements, recalls, continuous improvement projects, business initiatives, and a strong quality culture across the organization.