Principal Scientist, QC Compliance

About the role

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.

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
• Led initiatives to enhance compliance frameworks, inspection readiness, and audit outcomes
• Owes 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
• 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
• Acts as SME, within areas of responsibility, during FDA, customer, and internal audits
• Ensures audit findings are addressed with compliant corrective actions
• Supports QC inspection readiness efforts and internal/external regulatory inspections
• Owns 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
• 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
• Acts as SME, within areas of responsibility, during FDA, customer, and internal audits
• Ensures audit findings are addressed with compliant corrective actions
• 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

Qualifications

• 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
• 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

Requirements

• Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or related field required
• Master’s or PhD preferred
• 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

Pay

The 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.
Range: $113,754 - $177,695 Annually

Schedule

Set, full-time, consistent work schedule