Principal Scientist, QC Compliance
About The Position
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.
Requirements
- Deep expertise in cGMP, GDP, FDA 503B regulations, and laboratory compliance requirements
- Working knowledge of CFR, Eudralex, FDA guidance documents, ICH, ISO and Compendia
- Strong analytical problem-solving skills with ability to interpret complex data sets
- Demonstrated experience leading investigations, deviation management, and CAPA effectiveness
- Advanced understanding of analytical chemistry and microbiological testing principles
- Proven ability to influence cross-functional teams and drive compliance improvements
- Strong communication skills, including interaction with regulatory agencies and auditors
- High level of attention to detail and commitment to data integrity
- Legally authorized to work in the job posting country
- Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field required
- 10+ years of experience in pharmaceutical QC, QA, or compliance within a cGMP-regulated environment
- Significant experience in analytical and/or microbiology laboratory operations
- Demonstrated leadership in regulatory inspections, audits, and compliance remediation
- Experience with method validation, stability programs, and lab investigations required
- 18+ years of age
- Able to successfully complete a drug and background check
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
Nice To Haves
- Master's or PhD preferred
- Experience with LIMS, Empower, and laboratory data systems preferred
- Experience analyzing data and preparing data summaries using software, such as JMP and Minitab
- Experience working with project management software is a plus
- Experience in 503B outsourcing facilities or sterile manufacturing environments
- DEA compliance exposure (controlled substances)
- Lean/continuous improvement certification or experience
Responsibilities
- Serves as the subject matter expert (SME) for QC compliance across analytical chemistry and microbiology laboratories
- Ensures all QC activities comply with cGMP, GDP, SOPs, and regulatory requirements
- Provides oversight for laboratory equipment life cycle management, computer system validation and data integrity standards
- Leads initiatives to enhance compliance frameworks, inspection readiness, and audit outcomes
- Owns and monitors QC laboratory dashboards and KPIs
- Performs trend analysis of lab events, deviations, and investigations to identify systemic issues and recommend corrective actions
- Drives improvements in laboratory efficiency, turnaround time, and Right First Time (RFT) performance
- Leads and provide technical oversight of complex laboratory investigations (OOS, OOT, deviations, and customer inquiries)
- Ensures investigations are scientifically sound, compliant, and completed within established timelines
- Identifies recurring issues and implement robust CAPAs to prevent recurrence
- Supports QC inspection readiness efforts and internal/external regulatory inspections
- Acts as SME, within areas of responsibility, during FDA, customer, and internal audits
- Ensures audit findings are addressed with compliant corrective actions
- Oversees and provides guidance on regulatory standards, industry best practices and internal quality standards
- Supports the development and implementation of QC training programs and technical training modules
- Mentors and coaches QC scientists and analysts on compliance expectations and best practices
- Drives a culture of data integrity, quality ownership, and continuous learning
- Leads operational efficiency and process improvement initiatives across QC laboratories
- Supports capacity planning and utilization optimization
- Drives or supports strategic projects (e.g., specification harmonization, system enhancements)
- Authors, reviews, and approves SOPs, protocols, and reports to ensure regulatory compliance
Benefits
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 12 PTO, 5 PLP paid days off plus 8 paid holidays per year
- Occasional weekend and overtime opportunities with advance notice
- National, industry-leading high growth company with future career advancement opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
