Senior Quality Assurance Associate at WEP Clinical in Morrisville, NC

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 Senior Quality Assurance (QA) Associate plays a critical role within the Quality team, ensuring that pharmaceutical distribution and manufacturing activities are conducted in compliance with applicable regulatory standards (e.g., UK/EU/FDA GMP, GDP, and national health authority requirements). The role focuses on the daily oversight, execution, and improvement of quality processes and supporting client project delivery for the Post-Approval Named Patient (PA-NPP), Expanded Access Progamme (EAP), Commercial and Clinical Trial supply service lines.

The Ideal Candidate:

• Solutions-driven
• Critical thinker
• Strong communicator
• Adaptable

What You'll Do:

• Ensure GMP and GDP compliance across all regulated activities, maintaining best practices at all times.
• Prioritize and oversee compliance activities related to Wholesaler and Manufacturing Licenses/Authorisations in line with regulatory expectations.
• Manage key quality processes, driving operational compliance and identifying risks to patient safety, product quality, or regulatory adherence with effective mitigation strategies.
• Monitor, trend, and analyze quality incidents and metrics, proposing improvements to prevent recurrence and support management review.
• Lead and coordinate investigations for deviations, non-conformances, and complaints, ensuring robust root cause analysis and effective CAPA implementation.
• Initiate and support risk assessments, validation protocols, periodic reviews, and other quality system activities, including post-effectiveness checks for CAPAs and Change Controls.
• Drive timely completion and closure of critical quality records, ensuring appropriate supporting evidence is in place.
• Lead and support change controls, assessing impacts and risks and implementing necessary mitigating actions.
• Coordinate product recalls and mock recalls as required.
• Create, maintain, review, and archive GxP documentation, ensuring controlled document updates and effective document lifecycle management.
• Develop and execute validation and qualification strategies for shippers, equipment, facilities, IT systems, and warehouse operations, ensuring GMDP compliance.
• Support product disposition from quarantine, perform batch reviews, line clearances, quality inspections, label reviews, and secondary packaging oversight in accordance with SOPs.
• Support batch certification activities, including completion of Product Specification Files and escalation of quality issues to the Qualified Person as needed.
• Provide quality oversight and support for commercial, clinical trial, and supply chain projects, including client calls, technical agreements, audits, and regulatory inspections.
• Contribute to internal and external audits, supplier and vendor qualification, training, and continuous process improvements while promoting collaboration across the global Quality team and wider business.

What You'll Need:

• Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
• 2-5 years of experience in a Quality-related role within a regulated environment
• Practical experience in GxP Supply Chain, Production, and Quality Assurance, with knowledge of GMP, GDP, and the supply of unlicensed medicines (including distribution supply chains and unlicensed pathways preferred)
• Strong understanding of core Quality Management System processes, including risk assessments, deviations, change control, and supplier/customer management
• Ability to apply a risk-based approach to prioritize tasks effectively in day-to-day activities
• Proven ability to work cross-functionally on new processes, investigations, root cause analysis, and continuous improvement initiatives
• Strong critical thinking and analytical skills, particularly in conducting and reviewing investigations
• Excellent organizational, planning, time management, and administrative skills, with high attention to detail and accuracy under strict deadlines
• Effective verbal and written communication skills, with the ability to manage stakeholders, drive projects independently, and communicate business needs with minimal supervision
• Highly self-motivated, adaptable, solutions-oriented, and able to work independently under pressure, with strong interpersonal skills and proficiency in Microsoft Office, particularly Excel

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.

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