Senior QA GCP Manager

5 days ago

Alameda, California, United States Clinovo Full time
Job Title: Senior QA GCP Manager

Clinovo is seeking a highly skilled Senior QA GCP Manager to join our team. As a key member of our Quality Assurance department, you will play a critical role in ensuring the highest standards of quality and compliance in our GCP and PV operations.

Key Responsibilities:
  • Develop and implement QA systems and activities supporting GCP and PV operations
  • Assist in planning and conducting audits of vendors and associated documentation activities
  • Provide direct support to clinical study teams and participate in QA planning and implementation to support study operations
  • Participate in the development and approval of the CQA audit schedule, including the contracting of PV and GCP audits to contractors and conducting complex audits
  • Develop, track, and manage periodic management reports, including key Clinical and PV Compliance and QA metrics
  • Participate in and support various development teams
  • Manage and/or participate in complex audits and regulatory inspections
  • Independently determine approach to complex compliance issues and report findings to management with recommendations for resolution and verify appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented
  • Support, train staff, and oversee GCP/PV consultants
  • Implement policies and/or procedures within CQA
  • Partner with other groups, including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provide compliance guidance to all audited parties
  • Maintain knowledge of current regulation requirements and inform Clinical Development stakeholders of potential impact on the organization
  • Provide support during external audits and regulatory authority inspections
  • Participate in the development and delivery of GCP training internally
  • Represent CQA in internal presentations on quality issues, initiatives, and projects
Requirements:
  • Demonstrated knowledge of the drug development process
  • Demonstrated audit conduct and management experience, particularly in GCP and PV disciplines
  • 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 skills
  • Ability 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 processes
  • Has 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 Client project/program goals are met
  • Minimum 6+ years of progressive related experience
  • Experience in the biotech or pharmaceutical industry is preferred
  • BS/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 - $199K

Please 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.

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