QA Program Manager

Headwater Science•Research Triangle Park, NC

6d•Hybrid

About The Position

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.

Requirements

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 Haves

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.

Responsibilities

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.