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 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 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
• 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:
• Ensures compliance with 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

Our Most Successful Principal Scientist QC Compliance has:

• 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

Minimum Requirements for this Role:

• Legally authorized to work in the job posting country
• Bachelors degree in Chemistry Microbiology Pharmaceutical Sciences or related field required
• Masters 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

Any 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 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
• 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: $113754 - $177695 Annually

Quva 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 Pharmas multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners 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. Quvas 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. Quvas 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.

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Required Experience:

Staff IC