- Entry level
- No Education
- Salary to negotiate
- San Diego
Company in the Laboratory sector
- Lead and direct GXP processes for CAPA, complaints, change management, training, audits, deviation management anddocument & archival management.
- Drive education of best practices for Quality Management Systems, ensuring regulatory compliance and use of risk based processes.
- Partner with key functional areas in the organization to enhance the use of the electronic Document Management System andelectronic Learning Management System to ensure consistent application of documentation practices.
- Maintain appropriate computerized systems validation procedures and evidence of validation of all GXP systems in use atPrometheus.
- Lead the process for Management Review associated with CAPA, deviations, document management, training, and change control and ensure appropriate escalation of adverse trends.
- Lead the trending and metrics programs for Quality Systems related metrics; assess each functional area for trends and opportunities for improvement.
- Assure that deviations to procedures are captured and an impact assessment is conducted as appropriate.
- Ensure a robust CAPA program is in place with robust and timely processes for root cause analysis, verification of actions and effectiveness checks.
- Lead the process for reporting, investigating and trending of product complaints.
Ensure procedures are established to identify if a product complaint is reportable under applicable worldwide regulations and document the decision process.
- Drive the GMP/GDP change management program and implement efficient processes for the notification, assessment and implementation of changes to support program timelines
- Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness.
Participate in the development of responses to agency observations or deficiencies and ensure CAPAs are completed timely with appropriate effectiveness verification.
- Ensure Quality and Technical Agreements are strategically aligned with QMS requirements for notifications and delegation of responsibilities.
- Develop the QMS team with identification and on-boarding of key positions in oversight of quality management systems and applicable regulations.
- Provide estimates for budget planning as needed to identify audits, travel requirements, training and development of employees, systems, head count and other areas where financial resources are necessary.
- A minimum of a BA/BS degree preferably in life sciences.
- Minimum 15+ years of increasing responsibility in bio/pharmaceutical industry.
- Minimum of 8+ years' relevant experience in a Quality Assurance and/or Quality Management Systems role or an equivalent combination of education and experience.
- Demonstrated ability to interact with Global Health Authorities.
- Experience in quality metrics reporting, analysis and Operational Excellence tools and techniques.
- Demonstrated knowledge with the following regulations and guidance; 21 CFR, ICH Q10, EU GDP/GMP, MDSAP, Part 11/Annex 11, ISO, and CAP/CLIA.
- Prior experience with the design, validation and maintenance of Veeva or other Quality Management automated systems.
- Prior experience with the design, validation and maintenance of MasterControl or other Quality Management automated systems
- Strong leadership, team building, organizational, communication and interpersonal skills.
- Ability to work independently and to make decisions based on experience.