Senior GMDP Quality Assurance Manager

WEP Clinical; Morrisville (NC); Sur place; USD 170 000 - 230 000; Plein temps

Avantages offerts par ce poste

Medical, dental, and vision insurance

401K match

Résumé du poste

WEP Clinical is seeking a Senior GMDP Quality Assurance Manager to lead the site QA functions for US distribution and manufacturing activities, ensuring regulatory compliance and continuous improvement across GDP/GMP operations. You will partner with supply chain, project management, and other departments to deliver compliant client solutions.

The ideal candidate will bring 7+ years in pharma QA, strong leadership, and deep knowledge of GDP/GMP, data integrity, change control, and CAPA

Qualifications

• Bachelor’s degree or higher in a pharmaceutical, life sciences, or engineering field.
• Experience with GMP/GDP regulations and quality systems.
• Proven leadership and cross-functional collaboration abilities.
• Strong decision-making under time-sensitive conditions.

Responsabilités

• Oversee day-to-day site quality operations and ensure timely completion of critical quality records.
• Lead the Quality Management System and maintain GDP/GMP compliance.
• Own site quality performance metrics and drive data-led CAPAs and improvements.
• Provide hands-on QA oversight of warehouse, distribution, manufacturing, and packaging activities.
• Conduct risk assessments and act as escalation point for GxP issues.
• Oversee deviations, investigations, change controls, and product disposition.
• Coordinate with EU/UK Qualified Persons on communications and batch certification.

Connaissances

Attention to detail

Proactive and self-motivated

Calm under pressure

Leadership

Formation

Bachelors or higher in pharmaceutical, life sciences, or engineering

Outils

Microsoft Outlook

Microsoft Word

Microsoft Excel

Description du poste

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 Site US Senior GMDP Quality Assurance Manager will 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.

The Ideal Candidate

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

What You'll Do

• 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.

What You'll Need

• 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

Location eligibility applies. Candidates must reside in a U.S. state where the company is authorized to hire. This role is not eligible for residents of: California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia.

What We Offer

• Medical, dental, and vision insurance
• FSA, HSA
• Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance
• Group short-term and long-term disability insurance
• Group Life Insurance
• 401K safe harbor plan and company match
• Paid vacation, holiday, sick and volunteer time
• Paid maternity & paternity leave

What Sets Us Apart

WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalized service of a specialized provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.

We're Committed To Our Team

WEP has many initiatives to encourage wellness, growth and 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.

How We Work At WEP Clinical

At WEP Clinical, we look for individualswho are conscientious, exercise sound judgment, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives - and we are committed to helping our people grow and succeed in an inclusive, supportive environment.

Our Services Include

• Access Programs
• Clinical Trial Services
• Patient Site Solutions
• Clinical Trial Supply
• Market Access and Commercialization

Data Privacy Notice

WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.

Privacy Policy: https://www.wepclinical.com/privacy-policy/

Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/

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.