Senior QC Compliance Scientist — cGMP & Data Integrity Lead

QuVa Pharma, Inc.; Northern (KY); Hybrid; USD 114,000 - 178,000; Full time

Benefits offered by this job

Health insurance

401k retirement program

PTO/PLP and holidays

Job summary

Quva Pharma, Inc. is seeking a Principal Scientist, QC Compliance to lead laboratory compliance and data integrity across analytical chemistry and microbiology. This role partners with QA, Manufacturing, Technical Services, and Regulatory Affairs to strengthen quality systems and drive continuous improvement.

It is an on-site position based in Bloomsbury, NJ, USA. The candidate will oversee complex investigations, CAPAs, and inspection readiness while guiding training and SOP development to

Qualifications

• Legally authorized to work in the job posting country
• 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; No visa sponsorship

Responsibilities

• Serve as SME for QC compliance across analytical chemistry and microbiology
• Ensure QC activities comply with cGMP, GDP, SOPs, and regulatory requirements
• Oversee laboratory equipment life cycle management, computer system validation and data integrity standards
• Lead initiatives to enhance compliance frameworks, inspection readiness, and audit outcomes
• Own and monitor QC laboratory dashboards and KPIs
• Perform trend analysis of lab events, deviations, and investigations
• Drive improvements in laboratory efficiency and Right First Time performance
• Lead complex laboratory investigations (OOS, OOT, deviations) and customer inquiries
• Ensure investigations are scientifically sound and completed on time
• Identify recurring issues and implement robust CAPAs
• Support QC inspection readiness and regulatory inspections
• Act as SME during FDA, customer, and internal audits
• Ensure audit findings are addressed with compliant corrective actions
• Oversee development and implementation of QC training programs
• Mentor QC scientists and analysts on compliance expectations
• Drive data integrity and continuous improvement across QC labs
• Support capacity planning and utilization optimization
• Lead strategic projects (e.g., specification harmonization)
• Author, review, and approve SOPs, protocols, and reports

Skills

cGMP knowledge

GDP knowledge

Data integrity

Regulatory inspections

Lab operations

Analytical chemistry

Cross-functional leadership

Communication with regulators

Project management

LIMS/Empower

JMP

Minitab

Education

Bachelor's in Chemistry or related field

Master's or PhD preferred

Tools

LIMS

Empower

JMP

Minitab

Job description

Quva Pharma, Inc. is seeking a Principal Scientist, QC Compliance to lead laboratory compliance and data integrity across analytical chemistry and microbiology. This role partners with QA, Manufacturing, Technical Services, and Regulatory Affairs to strengthen quality systems and drive continuous improvement.

It is an on-site position based in Bloomsbury, NJ, USA. The candidate will oversee complex investigations, CAPAs, and inspection readiness while guiding training and SOP development to