Job details
Job type contract number of hires for this role 1
Qualifications
Us work authorization (preferred)
Full job description
Senior manager, quality assurance need to manage document control, also veeva-certified
About the role:
Provides oversight for the development and maintenance of quality programs, systems, processes, and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelinesProvides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure complianceWorks directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelinesManage and coordinate in-house sponsor inspection activities and implement strategic policies when selecting methods, techniques, and evaluation criteria for generating results.
Manages and provides direction for day-to-day quality assurance (qa) document control activities (i.e., system administration, inspection readiness, controlled documents, records management, and gxp training) in support of research and commercial projects across multiple therapeutic areasProvides quality assurance (qa) support and training to ensure adherence with applicable regulatory requirements and company policies/proceduresManages the development, implementation, and maintenance of quality assurance systems and activitiesManages creation, revision, and obsolescence of gxp controlled documentsProvides oversight and risk-based assessments in the maintenance of the veeva vault qualitydocs electronic document management system (emds) and quality management system (qms), and compliancewire learning management system (lms)Provides technical support and acts as the system owner for the edms and qms.
Your contributions (include, but not limited to):
Quality assurance document control:
Develop, modify, and execute company qa policies and programs ensuring that organizational products and processes meet established quality standards
Drives the development, implementation, and administration of an organizational quality management system and monitors progress against strategic quality-related goals
Manage the work of a team that collects data identifying potential quality failures, evaluates quality of materials, processes, or operations, and implements and measures the impact of corrective actions
Solicit internal and external feedback with the goal of continuously improving processes or products
Facilitate and support the creation, revision, and obsolescence of gxp controlled documents, to include reporting, periodic review, and trending
Inspection readiness:
Manage and coordinate in-house sponsor inspection activities and implement strategic policies when selecting methods, techniques, and evaluation criteria for generating results
Oversee the development, maintenance, and coordination of the inspection schedule, files, personnel, system tools, and processes
Study team support:
Oversee and provide support as archivist for clinical studies managed in the electronic clinical trial management system (ectms)
Assist in the assignment, tracking, and recording of gcp training requirements
Quality systems:
Lead and collaborate with a multidisciplinary team to help standardize commercial or development activities within and across programs through preparation of sops and personnel training
Implement quality systems, processes, and procedures within qa
Apply risk-based decision making and integrate into quality systems/quality processes, as appropriate
Conduct trend analyses of gxp quality system metrics for management reporting
Proactively identify areas for improvement and collaborate with qa and gxp departments on continuous improvement initiatives
Analyzes and develops process improvement initiatives in applications, not limited to edms, qms, and lms
Deploy and manage quality system attributes for hosted, cloud-based, as well as on-prem systems
Qa department support:
Identify, implement, and train all departments that utilize gxp principles on improvements and applicable regulations and guidelines
Lead the qa management to ensure compliance to regulations, guidelines, and gxp controlled documents
May work on other projects within qa not related to gxp
Gxp training:
Identify curricula, and lead process improvement initiatives in the lms
Oversee enterprise-wide management and implementation of gxp training requirements, deployment strategy, risk-based assessments of releases and configuration enhancements under change control
Lead implementation of training curricula, smart curricula, competency assessments, and annual gxp training requirements
Manage administration and support activities for service now (snow) tickets of gxp training items
Requirements:
Bs/ba degree in chemistry, biology, or related field or rn and 12+ years of in scientific or health care field and pharmaceutical industry experience, including 5+ years of cqa experience in drug developmentProven track record and experience in searching, review and implementation of regulatory requirements and guidelines including research of principal investigator regulatory histories or
Masters degree in chemistry, biology, or related field and 10+ years of similar experience noted above
Previous managerial / functional management experience also required
Clinical quality assurance
Expert knowledge of all clinical trial fda regulations and ich guidelines, and experience with international gcp regulations and guidelines is desired
Ability to create a comprehensive audit program and carry out audits of investigator sites and research vendors for phase i-iv studiesRequires an in-depth knowledge of auditing principles, techniques, and communication skills to convey findings and report deficiencies clearly and efficiently to investigator sites as well as the company’s management
Quality operations; quality manufacturing
Expert knowledge of fda regulations and ich guidelines, and experience with international gm regulations and guidelines is desired
Ability to manage quality systems / processes and perform risk analyses and create a risk-based programs, as appropriate
Ability to carry out audits of external vendors for development and commercial productRequires an in-depth knowledge of auditing principles, techniques, and communication skills to convey findings and report deficiencies clearly and efficiently to investigator sites as well as the company`s management
Quality general
Ability to identify and escalate problems and follow-through with the corrective actions
Ability to work closely with both internal and external personnel to increase the level of compliance and cooperation while creating opportunities to improve operations and effective implementation to reduce errors
Ability to manage the relationship between sponsor companies and contract manufacturers
G&l scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or raceWe recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&l is committed to everyone having the right to work in an environment free from threat of discrimination, intimidation, harassment, and abuseAll employees at g&l share the responsibility to challenge discriminatory behavior and promote equality of opportunity.
(jt: 1139)
Job type: contract
Schedule:
Monday to friday
Experience:
Cqa experience in drug development: 1 year (preferred)
Work remotely:
Yes
