Clinovo
Senior QA GCP Manager
Clinovo, Alameda, California, United States, 94501
Senior QA GCP Manager
Senior QA GCP Manager will assist in the development, implementationand maintenance of QA systems and activities supporting GCP and PV operations. Provides assistance with planning and conducting audits of vendors and associated documentation activities.
Responsibilities:
Responsible for assisting in the development of internal processes and systems related to GCP and PV QA activitiesProvides direct support to clinical study teams and participates in QA planning and implementation to support study operationsParticipates in the development and approval for the CQA audit schedule including the contracting of PV and GCP audits to contractors and conducting complex auditsResponsible for developing, tracking and managing periodic management reports including key Clinical and PV Compliance and QA metricsParticipates in and support various development teamsManages and/or participates in complex audits and regulatory inspectionsIndependently determines approach to complex compliance issues and reports findings to management with recommendations for resolution and verifies appropriate corrective actions and preventative actions (CAPAs) have been implemented and documentedSupports, trains staff and oversees GCP / PV consultantsImplements policies and/or procedures within CQAPartners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance to all audited partiesMaintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organizationProvides support during external audits and regulatory authority inspectionsParticipates in the development and delivery of GCP training internallyRepresents CQA in internal presentations on quality issues, initiatives and projects.Requirements:
Demonstrated knowledge of the drug development processDemonstrated audit conduct and management experience, particularly in GCP and PV disciplines is required.Working knowledge of supporting preparation and submission activities, specifically in relation to GCP and PV Quality, for global regulatory filings.Excellent verbal and written communication skillsAbility to influence others as part of a collaborative team and negotiate effective solutions, strong interpersonal and social skills.Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.Develops technical solutions to complex problems.Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.Guides the successful completion of major programs, projects and/or functions.Interprets, executes and recommends modifications to companywide policies and/or divisional programs.Has complete understanding and wide application of technical principles, theories, concepts and techniques.Detailed oriented and committed to precision in execution of tasks and processesHas knowledge of other related disciplines.Must be proficient in Word, Excel, PowerPoint and Visio.Minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training.Qualifications:
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.Able to multi-task (review and analyze study site and/or vendor audit reports and provide support to manage open CAPAs to closure).Works on complex issues where analysis of situations or data requires an in-depth knowledge of the clinical research and PV processes and corporate goals.Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.Work with various CROs and team members to ensure Clients project/program goals are met.Minimum 6+ years of progressive related experienceExperience in the biotech or pharmaceutical industry is preferredBS/BA degree in related discipline and a minimum of nine years of related experience; or, MS/MA degree in related discipline and a minimum of seven years of related experience; or, PhD in related discipline and a minimum of two years of related experience; or, Equivalent combination of education and experience.
Salary range: $140K - $199KPlease note, the hourly rate offered to the final candidate depends on relevant work experience, skills, and years of experience.
Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.
Senior QA GCP Manager will assist in the development, implementationand maintenance of QA systems and activities supporting GCP and PV operations. Provides assistance with planning and conducting audits of vendors and associated documentation activities.
Responsibilities:
Responsible for assisting in the development of internal processes and systems related to GCP and PV QA activitiesProvides direct support to clinical study teams and participates in QA planning and implementation to support study operationsParticipates in the development and approval for the CQA audit schedule including the contracting of PV and GCP audits to contractors and conducting complex auditsResponsible for developing, tracking and managing periodic management reports including key Clinical and PV Compliance and QA metricsParticipates in and support various development teamsManages and/or participates in complex audits and regulatory inspectionsIndependently determines approach to complex compliance issues and reports findings to management with recommendations for resolution and verifies appropriate corrective actions and preventative actions (CAPAs) have been implemented and documentedSupports, trains staff and oversees GCP / PV consultantsImplements policies and/or procedures within CQAPartners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance to all audited partiesMaintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organizationProvides support during external audits and regulatory authority inspectionsParticipates in the development and delivery of GCP training internallyRepresents CQA in internal presentations on quality issues, initiatives and projects.Requirements:
Demonstrated knowledge of the drug development processDemonstrated audit conduct and management experience, particularly in GCP and PV disciplines is required.Working knowledge of supporting preparation and submission activities, specifically in relation to GCP and PV Quality, for global regulatory filings.Excellent verbal and written communication skillsAbility to influence others as part of a collaborative team and negotiate effective solutions, strong interpersonal and social skills.Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.Develops technical solutions to complex problems.Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.Guides the successful completion of major programs, projects and/or functions.Interprets, executes and recommends modifications to companywide policies and/or divisional programs.Has complete understanding and wide application of technical principles, theories, concepts and techniques.Detailed oriented and committed to precision in execution of tasks and processesHas knowledge of other related disciplines.Must be proficient in Word, Excel, PowerPoint and Visio.Minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training.Qualifications:
Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.Able to multi-task (review and analyze study site and/or vendor audit reports and provide support to manage open CAPAs to closure).Works on complex issues where analysis of situations or data requires an in-depth knowledge of the clinical research and PV processes and corporate goals.Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.Work with various CROs and team members to ensure Clients project/program goals are met.Minimum 6+ years of progressive related experienceExperience in the biotech or pharmaceutical industry is preferredBS/BA degree in related discipline and a minimum of nine years of related experience; or, MS/MA degree in related discipline and a minimum of seven years of related experience; or, PhD in related discipline and a minimum of two years of related experience; or, Equivalent combination of education and experience.
Salary range: $140K - $199KPlease note, the hourly rate offered to the final candidate depends on relevant work experience, skills, and years of experience.
Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.