--- title: 'Senior GMDP Quality Assurance Manager at WEP Clinical' canonical: 'https://feeny.ai/job/senior-gmdp-quality-assurance-manager-wep-clinical-morrisville-north-carolina-hkg40f1ze5ks' type: 'job' last_seen: '2026-09-13' --- # Senior GMDP Quality Assurance Manager at WEP Clinical - **Company:** WEP Clinical - **Location:** Morrisville North Carolina, United States - **Employment:** full-time - **Work type:** hybrid - **Posted:** 2026-08-14 - **Last confirmed live:** 2026-09-13 - **Apply:** https://jobs.lever.co/wepclinical/3015d54c-1a18-4b75-9b18-3417a49cd710 ## Job description 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 individuals who 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/ How to Apply: To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English. Important Note: To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page. For Your Safety, Please Note: We will never communicate with you via Microsoft Teams or text message We will never ask for your bank account information at any stage of recruitment 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. #LI-Fulltime #LI-hybrid ## About WEP Clinical ## Company Overview - **One-liner**: WEP Clinical is a specialist Clinical Research Organization (CRO) that designs, manages, and executes clinical trials, expanded access programs (EAPs), and commercialization solutions for biotech and pharmaceutical sponsors worldwide. - **Entity Type**: Private (Privately Held) – most recent funding: Private Equity Round (Nov 2021, led by TJC) - **Headquarters**: London, United Kingdom (with significant US presence in Morrisville, North Carolina) - **Founded**: 2008 - **Founders**: Not publicly available ## Core Business - **Primary industry**: Clinical Research Organization (CRO) / Research Services - **Target customers**: B2B – biotech and pharmaceutical companies (sponsors) of all sizes - **Mission statement**: “With Every Patient” – connecting patients, physicians, and industry stakeholders to broaden treatment access worldwide, providing hope to those with life-threatening diseases. ## Products & Services - **Clinical Trial Management**: Full-service CRO covering planning, initiation, patient recruitment, monitoring, data management, and study close-out. - **Expanded Access Programs (EAPs)**: Managing pre-approval access to investigational therapies for patients with unmet medical needs. - **Post-Approval Named Patient Programs**: Facilitating access to approved therapies in countries where they are not yet commercially available. - **Market Access Solutions**: Supporting sponsors with market entry, regulatory strategy, and commercialization planning. - **Mobile Research Nursing Services**: Home-visit nursing for clinical trials, enabling decentralized trial options for patients across the US and UK. - **Clinical Trial Sourcing**: Procurement and supply chain solutions for investigational products. ## Market Standing - **Valuation / Market Cap**: Not disclosed (private company) - **Key Metric**: Annual Revenue of **$65M** (2025 estimate); Total Funding – Private Equity round led by **TJC** (2021, amount undisclosed) - **Notable Investors / Partners**: Lead investor: **TJC** (formerly The Jordan Company); key talent source partners include Thermo Fisher Scientific, ICON plc, Syneos Health, IQVIA, Fortrea - **Growth Signals**: 283 employees (with monthly headcount growth of +2.0%); presence across 15 countries; 210+ clinical programs completed; 12,500+ patients served; 500+ sites in 35+ countries; recent job postings indicate continued hiring (10 open roles as of Sept 2025) ## Competitive Advantages - **Patient-centric model**: Focus on access and patient convenience (home nursing, expanded access programs) - **Global reach**: Operations in 35+ countries with strong US-UK base and growing European presence - **Specialist expertise**: Deep experience in advanced therapies, autoimmune, CNS, cardiology, and other therapeutic areas - **Agility and flexibility**: Tailored solutions for biotech clients needing nimble, responsive CRO partnerships ## Strategic Focus - Expanding mobile nursing and decentralized trial capabilities to improve patient access and trial efficiency - Growing market access and commercialization service lines alongside traditional CRO offerings - Scaling team and infrastructure to support increasing global clinical programs (10 active job postings at time of research) - Deepening regulatory expertise to help sponsors navigate complex approval pathways ## Why Work Here - **Culture**: Emphasizes collaboration, innovation, and patient impact; values diverse experiences and perspectives. - **Work Flexibility**: Hybrid and remote roles available (e.g., fully remote Clinical Research Associate positions in the US, hybrid roles in Morrisville, NC and London, UK). - **Perks & Benefits**: Comprehensive private health insurance, generous personal development allowance, summer hours, education assistance, monthly office lunches/breakfasts, team outings, and summer/winter parties. - **Growth Opportunities**: Rapid expansion (monthly headcount growth +2%); career advancement potential with training, onboarding support (first 90 days+), and internal mobility. - **Professional Development**: Personal development allowance, ongoing training, and exposure to cutting-edge clinical projects. - **Global Team**: Diverse workforce across 15 countries with inclusive environment. ## Sources 1. [wepclinical.com – CRO Services Page](https://www.wepclinical.com/cro/) 2. [wepclinical.com – Careers Page](https://www.wepclinical.com/careers/) 3. [LinkedIn Company Profile – WEP Clinical](https://linkedin.com/company/we-pharma-ltd) 4. [CB Insights – WEP Clinical Profile](https://www.cbinsights.com/company/wep-clinical) 5. [Lever Jobs Board – WEP Clinical Openings](https://jobs.lever.co/wepclinical) ## Other roles at WEP Clinical - [HR Intern](https://feeny.ai/job/hr-intern-wep-clinical-morrisville-north-carolina-ss1pq0kbza7b) — Morrisville North Carolina, United States - [Responsible Person](https://feeny.ai/job/responsible-person-wep-clinical-dublin-dzr4mg1yajts) — Dublin, Ireland - [Associate Director, Regulatory Affairs](https://feeny.ai/job/associate-director-regulatory-affairs-wep-clinical-chiswick-london-2736wwwsc49j) — Chiswick London, United Kingdom - [Clinical Quality Assurance Manager](https://feeny.ai/job/clinical-quality-assurance-manager-wep-clinical-united-states-thbradrrcxwc) — United States - [cGMP Production Manager](https://feeny.ai/job/cgmp-production-manager-wep-clinical-dublin-p5abxmdxnge1) — Dublin, Ireland - [Senior Clinical Quality Assurance Associate](https://feeny.ai/job/senior-clinical-quality-assurance-associate-wep-clinical-united-states-fhk4t0h45kfc) — United States - [Bank Mobile Research Nurse - Oxford/Reading/Basingstoke – Adult Nurse](https://feeny.ai/job/bank-mobile-research-nurse-oxford-reading-basingstoke-adult-nurse-wep-clinical-wvf7kknj5mhp) — United Kingdom - [Clinical Research Nurse - Home Visits (PRN); Milwaukee, Wisconsin](https://feeny.ai/job/clinical-research-nurse-home-visits-prn-milwaukee-wisconsin-wep-clinical-1g1xj8npa1ee) — Milwaukee, WI - [Clinical Trial Project Manager](https://feeny.ai/job/clinical-trial-project-manager-wep-clinical-united-states-3rrz016xybmb) — United States - [Senior Clinical Research Associate](https://feeny.ai/job/senior-clinical-research-associate-wep-clinical-united-states-7ge7j3g5htax) — United States