Director, Quality Assurance-BBQA

Job Description

Job Description

Director, Quality Assurance-BBQA

About Quantive Intelligence

Quantive Intelligence (“QI”) is a Decision Sciences platform providing specialized biometrics expertise across biostatistics, statistical programming, and data management functions, supporting clinical development processes for pharmaceutical and biotechnology sponsors. QI was formed through the acquisitions of TechData Service Company, LLX Solutions, and R Square Technology. Collectively, these three founder-led organizations have 40+ years of operating history servicing 14 of the top 20 Large Pharma sponsors and the biotech community, supported by over 700 global employees, largely concentrated in the U.S. along with critical mass in China. QI operates as the intelligence layer between complex data and confident submissions, helping transform clinical trial data into clear, actionable insights that support regulatory approvals. Headquartered in King of Prussia, Pennsylvania, with additional presence in Waltham, Massachusetts, China, Taiwan, and India, QI serves a diversified base of pharmaceutical and biotechnology customers globally.

Director, Quality Assurance – Job Description

Reporting Line: Vice President, Quality Assurance

Position Summary

The Director, Quality Assurance – Biometrics is a senior individual contributor role responsible for leading quality assurance strategy, compliance oversight, and audit execution across biometrics programs and clinical operations. Reporting directly to the Vice President of Quality, this role serves as the subject matter expert for GCP/GxP compliance within biometric data management, ensuring the integrity and regulatory readiness of all biometrics-related deliverables.

This is a hands-on role requiring direct engagement in audits, inspections (if they occur), and cross-functional quality initiatives. The Director will collaborate closely with Biometrics colleagues, internal IT colleagues, and external vendors to embed a culture of quality and continuous improvement across the organization.

Key Responsibilities:

Quality Oversight & Compliance

● Serve as the primary QA liaison for Biometrics functions, including biostatistics, data management, statistical programming, and internal IT as well.

● Monitor and support GDPR compliance requirements through audits, process reviews, and corrective actions to ensure adherence to regulatory and quality standards; coordinating the completion of questionnaires by various groups (IT, Biostats, Data Management).

● Ensure all biometrics activities comply with applicable regulations and guidelines, including ICH E6(R3), 21 CFR Part 11, FDA, EMA, and other relevant global standards.

● Provide strategic quality guidance and oversight across the full Biometrics lifecycle, from protocol development through final study reports, if applicable.

● Demonstrate familiarity with AI-enabled technologies and automation tools, assessing their use within biometrics processes to support quality, efficiency, data integrity, and regulatory compliance.

Audits & Inspections

● Plan, lead, and observe audits of biometrics processes, systems, and deliverables, including CDISC standards (SDTM, ADaM), statistical analysis plans, and clinical databases.

● Conduct vendor and partner audits for EDC vendors, and other third-party providers supporting biometrics activities.

● Host new client qualification audits and re-qualification audits.

● Prepare and support the organization during regulatory inspections; support our clients during the audit process.

● Author, review, and track audit reports, findings, CAPAs, and risk assessments.

Integration & Cross-Functional Collaboration

● Lead quality integration activities for biometrics in the context of mergers, acquisitions, or organizational transitions, ensuring seamless alignment of systems, SOPs, and compliance standards.

● Partner with IT to drive end-to-end integration of quality frameworks across platforms and data flows.

● Champion cross-functional process improvement initiatives and serve as a key stakeholder in the development and maintenance of biometrics-related SOPs, work instructions, and quality metrics.

Quality Systems & Continuous Improvement

● Contribute to the ongoing development and maintenance of the Quality Management System (QMS) as it pertains to Biometrics operations, in partnership with IT.

● Support training programs and quality awareness initiatives for Biometrics staff.

Qualifications:

Education & Experience

● Bachelor's degree required in life sciences, statistics, or related field; advanced degree (MS, PhD) preferred.

● Minimum of 10 years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry.

● Minimum of 5 years of direct experience in biometrics QA, with deep expertise in data management, biostatistics, or statistical programming quality oversight.

● Hands-on experience with 21 CFR Part 11, and qualifying EDC vendors.

● Experience supporting or leading quality integration activities in a corporate transaction or organizational change context is a strong plus.

Skills & Competencies

● Deep knowledge of GCP/ICH/GDPR regulations and global regulatory requirements applicable to biometrics and clinical data.

● Strong audit execution skills with the ability to identify compliance gaps, write clear findings, and drive CAPAs to resolution.

● Excellent written and verbal communication skills; ability to present complex quality issues to senior leadership and cross-functional stakeholders.

● Proven ability to work independently and manage multiple priorities in a fast-paced environment.

● Collaborative, solutions-oriented mindset with strong influencing skills in a matrix organization.

● No direct reports; operates as a senior individual contributor with high organizational impact.

Location – preferred locations include the greater Boston or New England Area. Office is in Waltham, MA. For an ideal candidate they can be based in the Philadelphia areas.