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Salary
$80k – $162k per year (Estimated)
Location
Remote/Hybrid (Raleigh, United States)
Seniority
Senior · 3+ years exp
Employment
Contractor
Overview
Company
Impact
Profile match
ProPharma Group is a regulatory and compliance services company headquartered in Raleigh, North Carolina, and founded in 2001. The company provides pharmacovigilance, medical information call centres, regulatory affairs, quality assurance, and clinical research consulting to pharmaceutical, biotechnology, and medical device sponsors. It operates as a research consulting organisation rather than a trial running CRO, supporting products from development through post-market surveillance worldwide.

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

We are seeking a Sr. Business Analyst to support the global Quality & Compliance function of a major pharmaceutical client. This role sits at the intersection of requirements analysis, laboratory systems, and quality assurance, supporting the end-to-end process from requirements discovery through system verification.

The team researches and assembles Data Packets that support requirements gathering and serve as the foundation for Design Specifications. These Design Specifications are then used to configure the LabVantage LIMS platform. Once configurations are complete, the team performs formal verification activities to ensure the system has been implemented accurately and in accordance with approved specifications.

Success in this role requires strong analytical thinking, attention to detail, and the ability to interpret user requirements to determine what information is relevant, complete, and necessary. This is not a generic business analyst role. It combines requirements analysis, regulated documentation, system configuration support, and verification within a GxP-controlled environment.

Our client lead has called this team "ninjas" for how quickly we cross-train, adapt to new assignments, and maintain a high standard of quality while working across multiple workstreams. That's the bar for this hire.

What You'll Do

  • Research and assemble Data Packets by reviewing Jira user stories and identifying the appropriate Veeva-controlled documents, specifications, protocols, and supporting materials needed to support system design and configuration.

  • Analyze requirements and source documentation to determine relevant content, reconcile information across systems, and ensure Data Packets are complete and accurate.

  • Support the development of Design Specifications by organizing and documenting requirements in a structured, traceable manner.

  • Verify LabVantage LIMS configurations against approved Design Specifications, documenting results and identifying discrepancies, defects, or implementation gaps.

  • Partner with developers, configuration specialists, project team members, and client stakeholders to investigate and resolve verification findings.

  • Maintain high-quality documentation and adherence to GxP, quality, and validation standards.

  • Communicate proactively with teammates and client stakeholders to drive clarity, alignment, and timely resolution of issues.

What We're Looking For

  • 3-7 years of experience in pharmaceutical, biotechnology, laboratory, quality, validation, or regulated systems environments.

  • Bachelor's degree required; Life Sciences, Computer Science, Information Systems, or related field preferred.

  • Experience working with LIMS platforms; LabVantage experience strongly preferred.

  • Familiarity with Veeva, Tableau, ELN, LES/MES, eQMS, or other regulated laboratory and quality management systems.

  • Experience gathering, analyzing, and documenting business or system requirements.

  • Experience with software testing, system verification, validation, or quality assurance activities in a regulated environment.

  • Prior business analyst, validation, quality systems, or project coordination experience preferred.

How You Work

  • Highly detail-oriented with a strong quality and compliance mindset.

  • Able to analyze ambiguous requirements and apply sound judgment when determining what information is relevant and necessary.

  • Fast learner who can work across multiple functions and quickly adapt to changing priorities.

  • Self starter who can work independently, seeking opportunities to stay billable.

  • Confident communicator who can effectively partner with client stakeholders, vendor teams, and internal colleagues.

  • Curious, coachable, and committed to continuous learning.

  • Collaborative, humble, and willing to contribute wherever the team needs support.

  • Proactive in identifying risks, raising questions, and driving issues to resolution

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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