Director, Quality Systems
New
J
JobgetherPharmaceutical biotechnology
Fully remote within the continental United States.Full-TimeDirector
SalaryBase salary: $220,000–$235,000 USD annually, depending on experience, skills, qualifications, and internal equity. Annual incentive: Eligible for an annual target bonus. Equity compensation: Eligible for equity compensation, subject to the compensation committee's determination.
Apply NowOpens the employer's application page
Job Details
- Experience
- At least 8 years of experience in GxP Quality within the biotechnology or pharmaceutical industry, including experience across both GMP and GCP environments.
- Required Skills
- GCPRisk Management
Requirements
- Hold a bachelor's degree in a scientific discipline or related field; an advanced degree is an advantage.
- Have at least 8 years of GxP Quality experience in the biotechnology or pharmaceutical industry.
- Bring experience across both GMP and GCP environments.
- Have demonstrated experience leading quality professionals and building, implementing, or managing a comprehensive QMS.
- Have strong knowledge of enterprise QMS processes, including deviations, CAPA, change control, document control, training, and risk management.
- Have expertise in computerized system validation or computer software assurance, including lifecycle management, risk-based validation, and data integrity practices.
- Have direct experience supporting regulatory inspections, including Pre-Approval Inspections (PAIs).
- Have strong communication, leadership, and stakeholder management skills for cross-functional and external collaboration.
- Have experience in a growing or evolving organization and the ability to establish structure while adapting to changing business needs.
- A quality-related professional certification is preferred.
- Experience scaling quality systems for organizational growth, commercialization, or launch readiness is an advantage.
Responsibilities
- Develop, implement, maintain, and continuously improve an integrated QMS covering GxP activities across GMP and GCP.
- Own and optimize deviations, CAPA, change control, document control, training, risk management, CSV, and CSA processes.
- Provide quality oversight and approval of computerized system validation deliverables and related quality events.
- Establish quality metrics, prepare quarterly dashboards, lead Quality System Management Reviews, and track corrective actions.
- Oversee complaint intake, documentation, investigations, outsourced vendor coordination, and recall procedures.
- Lead inspection preparation and support regulatory inspections and audits, including Pre-Approval Inspections.
- Maintain an effective audit schedule and program.
- Partner with internal stakeholders, GMP and GCP quality leaders, and external service providers to integrate quality requirements into business processes.
- Build scalable, risk-based quality processes and lead quality professionals in fostering quality ownership and continuous improvement.
View Full Description & ApplyYou'll be redirected to the employer's site
