{"id":3323092,"url":"https://alion.io/job/onequva-principal-scientist-qc-compliance","title":"Principal Scientist, QC Compliance","company":{"id":3832669,"name":"Onequva","domain":"onequva.com","url":"https://alion.io/company/onequva","size_band":"501-1000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"UltiPro","truth_index":null},"role":"Science & Research","role_family":"Science & Research","seniority":"lead","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Bloomsbury, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":113754,"max":177695,"currency":"USD","period":"year","gross":null,"usd_annual":177695},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"JMP","optional":false},{"name":"LIMS","optional":false},{"name":"Minitab","optional":false},{"name":"Machine Learning","optional":true}],"status":"live","first_seen_at":"2026-09-29T14:49:27Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-28T13:00:57Z","board_verified":true,"closed_at":null,"days_open":29,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":29},"description":"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.\nThis is an on-site role in Bloomsbury, New Jersey.\nWhat the Principal Scientist, QC Compliance Does Each Day:\nServes as the subject matter expert (SME) for QC compliance across analytical chemistry and microbiology laboratories\nEnsures all QC activities comply with cGMP, GDP, SOPs, and regulatory requirements\nProvides oversight for laboratory equipment life cycle management, computer system validation and data integrity standardsLeads initiatives to enhance compliance frameworks, inspection readiness, and audit outcomes\n\nOwns and monitors QC laboratory dashboards and KPIs, including:Performs trend analysis of lab events, deviations, and investigations to identify systemic issues and recommend corrective actions\nDrives improvements in laboratory efficiency, turnaround time, and Right First Time (RFT) performance\nLeads and provide technical oversight of complex laboratory investigations (OOS, OOT, deviations, and customer inquiries)\nEnsures investigations are scientifically sound, compliant, and completed within established timelines\nIdentifies recurring issues and implement robust CAPAs to prevent recurrence\nSupports QC inspection readiness efforts and internal/external regulatory inspections\nActs as SME, within areas of responsibility, during FDA, customer, and internal audits\nEnsures audit findings are addressed with compliant corrective actions\n\nOversees and provides guidance on:Ensures compliance with regulatory standards, industry best practices and internal quality standards\nSupports the development and implementation of QC training programs and technical training modules\nMentors and coaches QC scientists and analysts on compliance expectations and best practices\nDrives a culture of data integrity, quality ownership, and continuous learning\nLeads operational efficiency and process improvement initiatives across QC laboratories\nSupports capacity planning and utilization optimization\nDrives or supports strategic projects (e.g., specification harmonization, system enhancements)\nAuthors, reviews, and approves SOPs, protocols, and reports to ensure regulatory compliance\n\nOur Most Successful Principal Scientist, QC Compliance has:\nDeep expertise in cGMP, GDP, FDA 503B regulations, and laboratory compliance requirements\nWorking knowledge of CFR, Eudralex, FDA guidance documents, ICH, ISO and Compendia\nStrong analytical problem-solving skills with ability to interpret complex data sets\nDemonstrated experience leading investigations, deviation management, and CAPA effectiveness\nAdvanced understanding of analytical chemistry and microbiological testing principles\nProven ability to influence cross-functional teams and drive compliance improvements\nStrong communication skills, including interaction with regulatory agencies and auditors\nHigh level of attention to detail and commitment to data integrity\nExperience with LIMS, Empower, and laboratory data systems preferred\nExperience analyzing data and preparing data summaries using software, such as JMP and Minitab\nExperience working with project management software is a plus\nMinimum Requirements for this Role:\nLegally authorized to work in the job posting country\nBachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field\n10+ years of experience in pharmaceutical QC, QA, or compliance within a cGMP-regulated environment\nSignificant experience in analytical and/or microbiology laboratory operations\nDemonstrated leadership in regulatory inspections, audits, and compliance remediation\nExperience with method validation, stability programs, and lab investigations\n18+ years of age\nAble to successfully complete a drug and background check\nMust be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas\nAny of the Following Will Give You an Edge:\nMaster’s or PhD\nExperience in 503B outsourcing facilities or sterile manufacturing environments \nDEA compliance exposure (controlled substances) \nLean/continuous improvement certification or experience \nBenefits of Working at Quva:\nSet, full-time, consistent work schedule\nComprehensive health and wellness benefits including medical, dental and vision\n401k retirement program with company match\n12 PTO, 5 PLP paid days off plus 8 paid holidays per year\nOccasional weekend and overtime opportunities with advance notice\nNational, industry-leading high growth company with future career advancement opportunities\nThe 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 conditions\nRange: $113,754 - $177,695 Annually\nQuva 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.\nQuva 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. 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