Sr. Mgr., Quality Management Systems
B
BridgeBioBiotechnology/Pharmaceutical
Remote - USAFull-TimeManager
Salary$147,700 — $176,500 USD
Apply NowOpens the employer's application page
Job Details
- Experience
- Minimum of 7 years of progressive Quality Assurance or related experience
- Required Skills
- Quality Assurance
Requirements
- Bachelor's degree in a scientific or technical discipline, or equivalent experience.
- Minimum of 7 years of progressive Quality Assurance or related experience in the pharmaceutical or biotechnology industry.
- Proven experience building, deploying, and improving a QRM program.
- Facilitation skills for cross-functional risk assessments using tools like risk ranking, hazard analysis, and FMEA.
- Working knowledge of GxP regulations and global regulatory expectations.
- Hands-on experience with Veeva Vault Quality applications, including QualityDocs, Training, and QMS.
- Experience with Computer System Validation (CSV) for GxP computerized systems.
- Experience with APQR/PQR activities, QRM metrics, or Management Review reporting.
- Ability to lead cross-functional initiatives and communicate risk-based quality guidance.
Responsibilities
- Lead the development, deployment, and continuous improvement of the QRM program, including procedures, templates, and tools.
- Facilitate cross-functional risk assessments using methodologies such as hazard analysis and FMEA.
- Serve as a trained backup for Document Control and GxP Training activities, maintaining inspection-ready records.
- Collaborate across functions to promote a quality culture and provide risk-based guidance.
- Support eQMS administration, optimization, and validation of GxP computerized systems.
- Maintain audit-ready QMS documentation and support regulatory inspection preparation and response.
View Full Description & ApplyYou'll be redirected to the employer's site
