QA Program Manager

Headwater Science; North Carolina; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Health, dental & vision coverage

401(k) with company match

Generous PTO & holidays

Parental leave

Job summary

Headwater Science, hybrid in Research Triangle Park, NC, seeks a QA Program Manager to oversee Regulatory Affairs and QA, develop and maintain quality systems, and mitigate compliance risks across the organization.

You will lead SOPs/WIs, review data for GDP, and ensure GCP/GPP compliance while partnering with cross-functional teams including FDA-inspections and CROs.

Qualifications

• Bachelor's degree in a Life Sciences discipline or related field with 5+ years of relevant experience.
• Experience working with pharmaceutical companies and CROs.
• Knowledge of evolving regulatory standards as they apply to Real World Evidence.
• Experience in real world evidence, registries, observational studies, third-party data analysis, or non-interventional research preferred.
• Ability to partner with and guide multi-disciplinary teams from project inception through completion, including FDA requirements, agency inspections, vendor audits, and corrective actions.

Responsibilities

• Serve as regulatory affairs and QA resource for all functional areas, esp. Real World Evidence.
• Act as consultant on regulatory strategy matters.
• Lead risk assessments and audits of processes and systems.
• Oversee all aspects of the Quality Management System (QMS).
• Review vendor data and quality records for GDP conformance.
• Lead development and management of SOPs and Work Instructions.
• Support teams in SOP/WI development for their areas.
• Develop and maintain GCP and GPP compliance processes.

Skills

Regulatory affairs

Quality assurance

GxP

Real World Evidence

FDA inspections

Education

Bachelor's degree in Life Sciences

Job description

QA Program Manager

Hybrid – 3 Days Onsite · Research Triangle Park, NC

About Headwater Science

Headwater Science (formerly NoviSci) is a data science and methods company specializing in principled, reproducible evidence generation for complex clinical and regulatory challenges. With deep expertise in comparative effectiveness, causal inference, healthcare utilization and expenditure research, and regulatory-grade analytical software, Headwater Science provides the methodological foundation that delivers reproducible analytic pipelines, novel epidemiologic and statistical methods, and regulatory-grade software validated to hold up under the most demanding scrutiny. The company works with life sciences organizations as a long-term scientific partner. Headwater Science is a Highlander Health company. Learn more at headwaterscience.com.

The Role

We are seeking a talented QA Program Manager to join our team. In this role, you will lead the Regulatory Affairs/Quality Assurance (QA) function to develop, implement, monitor, and maintain quality systems and policies, and to ensure compliance risks are identified and mitigated.

What You'll Do

• Serve as the regulatory affairs and quality assurance resource for all functional areas of the company, particularly as related to the use of Real World Evidence.


• Act as a consultant on regulatory strategy matters.


• Lead risk assessments and audits of processes and systems.


• Oversee all aspects of the Quality Management System (QMS).


• Review vendor-supplied data and quality records for conformance to Good Documentation Practices (GDP).


• Lead the development and management of company-wide Standard Operating Procedures (SOPs) and Work Instructions (WIs).


• Support functional teams in the development of SOPs and WIs specific to their areas.


• Develop and maintain Good Clinical Practice (GCP) and Good Pharmacoepidemiology Practices (GPP) compliance processes to control the quality of work.


• Maintain current knowledge of GCP/GPP guidance and regulations, and proactively inform management and program teams of relevant changes and compliance issues.


• Manage the internal SOP training program for all employees, ensuring organization-wide compliance and refining the program as needed.

What You'll Bring

• Bachelor's degree in a Life Sciences discipline or related field, with 5+ years of relevant experience.


• Experience working with pharmaceutical companies and Contract Research Organizations (CROs).


• Knowledge of evolving regulatory standards as they apply to Real World Evidence.


• Experience in real world evidence, registries, observational studies, third-party data analysis, or non-interventional research strongly preferred.


• Demonstrated ability to partner with and guide multi-disciplinary teams from project inception through completion, including FDA requirements, agency inspections, vendor audits, and corrective actions.

Nice to Have

• RAC (Regulatory Affairs Certification) or equivalent credential.


• Familiarity with FDA Real World Evidence guidance frameworks.


• Experience with 21 CFR Part 11 electronic records and signatures compliance.

What We Offer

• Hybrid work environment – 3 days onsite per week.


• Comprehensive health, dental, and vision coverage for you and your family.


• 401(k) with company match.


• Generous PTO and company holidays.


• Paid parental leave.

If you are ready to be part of a team where your work truly matters- where your expertise is valued, your growth is supported, and your contributions help shape the future of healthcare- Headwater Science is the place for you. We're building something meaningful together, and we'd love for you to be a part of it.

Headwater Science is an equal opportunity employer and seeks candidates from diverse backgrounds and abilities.