Job details
Salary $120,000 - $150,000 a year
Full job description
Description:
The quality assurance gcp manager is responsible for arranging, conducting and reporting on gcp audits of clinical research organizations, vendors, and systems as well as oversight of the clinical operations and viridian clinical trialsParticipates in cross-functional teams providing guidance and risk-based optionsReviews study documents and checks for consistency and appropriate standards and practicesAssists in the creation and maintenance of audit toolsWhen appropriate, prepares and/or revises gcp sops and work instructionsWorks with cross-functional teams to provide gcp adviceMaintains good working relationships and communication with gcp customers and staffEssential duties include:
Ensures clinical operations and viridian clinical trials are complaint with fda and row regulatory expectations
Arranges, conducts and reports on gcp audits of clinical research organizations, investigators, vendors, and systems
Collaborate with other compliance/quality functions to ensure alignment and comprehensive compliance support for translational science and clinical operations.
Ensure escalation of significant compliance matters to director of quality and appropriate oversight bodies
Develops and maintain quality procedures aligned with gcp concepts
Works within cross-functional teams, ensuring compliance to regulatory guidance and internal document standards;
Acts as a qa representative in program and protocol team meetings.
Works directly with cro’s and other external contractors and collaborators, managing the chain of communication related to gcp compliance;
Performs quality control (qc) of clinical and non-clinical data as well as clinical documents
(protocol, ib, etc.) as requested;
Approximately 5-10% travel per year
Requirements:
Qualifications:
Suitable candidates will possess a bachelor’s degree in a life science or engineering, and 5+ years of quality assurance experience in the biotechnology and/or pharmaceutical industryExtensive knowledge of clinical trials in the us and eu and regulatory standards at all phases of drug development is preferred.
Required skills:
Clear record of success as a qa manager in a biopharma or pharmaceutical environment;
Clear understanding of fda and international regulatory requirements;
Experience in the area of therapeutic antibodies highly desired, rare disease experience a plus.
Adept at prioritizing and completing tasks in a high-pressure environment;
Proven leadership within a cross-functional project team;
Ability to persuasively and effectively interact with partners, collaborators and cro’s;
Demonstrated ability to anticipate and address issues;
Exceptional oral and written communication skills including excellent technical writing abilities.
Compensation: the salary range for this position is $120,000 – $150,000 and commensurate with experienceViridian offers a comprehensive benefits package including:
Medical, dental, and vision coverage with 100% of premiums paid by viridian for employees and their eligible dependents.
Short- and long-term disability coverage
Group term life insurance
Medical and dependent care fsa
401(k) company match
Employee stock purchase plan
