Principal Scientist, QC Compliance

The Principal Scientist, QC Compliance serves as a senior technical and compliance leader within the Quality Control organization, providing strategic oversight of laboratory compliance, data integrity, and performance across analytical and microbiology functions. This role is responsible for ensuring QC operations consistently meet cGMP, GDP, FDA 503B, and regulatory expectations while driving inspection readiness, continuous improvement, and operational excellence. This position partners cross-functionally with Quality Assurance, Manufacturing, Technical Services, and Regulatory Affairs to strengthen quality systems, improve laboratory performance, and ensure sustainable compliance. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.This is an on-site role in Bloomsbury, New Jersey. What the Principal Scientist, QC Compliance Does Each Day:Serves as the subject matter expert (SME) for QC compliance across analytical chemistry and microbiology laboratoriesEnsures all QC activities comply with cGMP, GDP, SOPs, and regulatory requirementsProvides oversight for laboratory equipment life cycle management, computer system validation and data integrity standardsLeads initiatives to enhance compliance frameworks, inspection readiness, and audit outcomesOwns and monitors QC laboratory dashboards and KPIs, including:Performs trend analysis of lab events, deviations, and investigations to identify systemic issues and recommend corrective actionsDrives improvements in laboratory efficiency, turnaround time, and Right First Time (RFT) performanceLeads and provide technical oversight of complex laboratory investigations (OOS, OOT, deviations, and customer inquiries)Ensures investigations are scientifically sound, compliant, and completed within established timelinesIdentifies recurring issues and implement robust CAPAs to prevent recurrenceSupports QC inspection readiness efforts and internal/external regulatory inspectionsActs as SME, within areas of responsibility, during FDA, customer, and internal auditsEnsures audit findings are addressed with compliant corrective actionsOversees and provides guidance on:Ensures compliance with regulatory standards, industry best practices and internal quality standardsSupports the development and implementation of QC training programs and technical training modulesMentors and coaches QC scientists and analysts on compliance expectations and best practicesDrives a culture of data integrity, quality ownership, and continuous learningLeads operational efficiency and process improvement initiatives across QC laboratoriesSupports capacity planning and utilization optimizationDrives or supports strategic projects (e.g., specification harmonization, system enhancements)Authors, reviews, and approves SOPs, protocols, and reports to ensure regulatory complianceOur Most Successful Principal Scientist, QC Compliance has:Deep expertise in cGMP, GDP, FDA 503B regulations, and laboratory compliance requirementsWorking knowledge of CFR, Eudralex, FDA guidance documents, ICH, ISO and CompendiaStrong analytical problem-solving skills with ability to interpret complex data setsDemonstrated experience leading investigations, deviation management, and CAPA effectivenessAdvanced understanding of analytical chemistry and microbiological testing principlesProven ability to influence cross-functional teams and drive compliance improvementsStrong communication skills, including interaction with regulatory agencies and auditorsHigh level of attention to detail and commitment to data integrityExperience with LIMS, Empower, and laboratory data systems preferredExperience analyzing data and preparing data summaries using software, such as JMP and MinitabExperience working with project management software is a plusMinimum Requirements for this Role:Legally authorized to work in the job posting countryBachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field requiredMaster’s or PhD preferred10+ years of experience in pharmaceutical QC, QA, or compliance within a cGMP-regulated environmentSignificant experience in analytical and/or microbiology laboratory operationsDemonstrated leadership in regulatory inspections, audits, and compliance remediationExperience with method validation, stability programs, and lab investigations required18+ years of ageAble to successfully complete a drug and background checkMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visasAny of the Following Will Give You an Edge: Experience in 503B outsourcing facilities or sterile manufacturing environments DEA compliance exposure (controlled substances) Lean/continuous improvement certification or experience Benefits of Working at Quva:Set, full-time, consistent work scheduleComprehensive health and wellness benefits including medical, dental and vision401k retirement program with company match12 PTO, 5 PLP paid days off plus 8 paid holidays per yearOccasional weekend and overtime opportunities with advance noticeNational, industry-leading high growth company with future career advancement opportunitiesThe base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditionsRange: $113,754 - $177,695 AnnuallyQuva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva’s overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is “at will.”California Consumer Privacy Act (CCPA) Notice for Applicants and EmployeesJob SummaryRequisition Number: PRINC006096Job Category: 8000-QualitySchedule: Full-Time