$100K — $150K *
As a QA professional, provides oversight of day-to-day clinical trial operations activities, partnering with the Clinical Trial teams to provide a strong GCP perspective and identify and address issues and risks. Escalates issues in a timely fashion so proper steps can be taken to secure patient safety and management of the clinical data. Ability to audit clinical operations as well as scheduling and documenting audits. Provides a high level of independent judgment in managing and executing quality assignments.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Maintains the CQA programs, policies, and procedures to ensure GCP compliance.
• Assist in developing internal processes and systems related to GCP QA activities
• Provides direct support to clinical study teams and participates in QA planning and implementation to support study operations;
• Participation in the development and approval for the CQA audit schedule including the contracting of GCP audits to contractors and conducting complex audits;
• Responsible for developing, tracking and managing periodic management reports including key Clinical and QA metrics that track and trend the quality health of the GCP activities.
• Manage and/or participate in audits and regulatory inspections;
• Review and approve Corrective and Preventive Actions (CAPAs)
• Implementation of policies, procedures and controlled documents related to 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
• Represent CQA in internal presentations on quality issues, initiatives and projects
• Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner.
• Participate in identifying and implementing process and system improvements.
• Minimum of Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field)
• Minimum 8 years of relevant experience in pharmaceutical/biotech
• Minimum 6 years GCP Quality Assurance experience preferred
• Experience in assisting the development of business strategies, metrics, and continuous improvements
• Demonstrated knowledge of the drug development process
• Demonstrated audit conduct and management experience in GCP disciplines
• Working knowledge of supporting preparation and submission activities, specifically in relation to GCP Quality, for global regulatory filings
• Working knowledge of key Health Authority rules and regulations as well as international standards.
• 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.
• 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
• Detailed oriented and committed to precision in execution of tasks and processes
• Evaluates and generates data to support Key Performance Indicators.
• Implements technical solutions within quality requirements to complex problems.
• Excellent verbal and written communication skills
• Proficient in MS Office and Visio (preferred).
Valid through: 12/24/2020