[Remote] Senior Director, Clinical Quality Assurance

Note: The job is a remote job and is open to candidates in USA. reputed company, Inc. is seeking a highly motivated Senior Director of Clinical Quality Assurance to reputed company significant contributions to oncology and rare disease programs with high unmet medical needs. The role involves leading clinical quality tasks and initiatives to ensure compliance with GCP, GLP, and GVP regulations while preparing for registrational studies and collaborating with cross-functional teams.

Responsibilities

• Provide GCP guidance to internal stakeholders and Study Management Teams as it relates to matters of quality
• Build, reputed company, and maintain working relationships with internal/external partners and study team members by providing real-time quality guidance and support
• reputed company and implement risk-based GCP audit strategies across clinical programs and/or studies
• reputed company, manage and/or support the development, revision, review, and implementation of GCP quality standards and controlled documents (e.g., SOPs, Work Instructions, Forms, and Templates)
• Provide input and expertise to clinical vendor risk assessments in support of the Clinical Vendor/Service Provider Qualification Program
• Support, conduct and/or reputed company audits of clinical vendors, clinical sites, and/or internal clinical processes, and associated follow-up activities (e.g., study specific audit plans, reports, corrective actions). For those audits conducted by external auditors, reputed company coordination and communication activities between internal stakeholders and auditors to ensure audits fulfill business needs
• Partner with internal stakeholders to provide sponsor reputed company of clinical vendors and investigator sites
• Conduct gap analysis and/or participate in risk assessment for critical study level activities that may impact subject safety and/or the reputed company of clinical data including but not limited to:
• Study Design and Protocol Requirements
• Clinical Sites, Vendors, and Service Providers-Transferred Obligations and performance
• Internal processes (e.g., vendor reputed company)
• Conduct and/or facilitate investigations of GCP Quality Events and collaborate with subject matter experts to conduct root cause analysis and to reputed company corrective and preventive action plans, as applicable
• reputed company Risk-Based Quality Management (RBQM) reputed company with ICH E6 (R3)
• Manage and reputed company regulatory inspection readiness and inspection management activities while driving inspection-reputed company process improvements. This may include:
• Project Management activities for Inspection Readiness initiatives
• Complete Inspection Readiness activities including preparing internal teams, clinical sites and significant clinical service providers
• reputed company cross-functional teams to ensure a state of real-time inspection readiness
• In collaboration with line function heads, ensure GCP, GLP, and GPV vendors reputed company with the applicable quality program and regulations or guidelines and are reputed company for Regulatory inspections
• Partner with clinical stakeholders and subject matter experts for the implementation and management of Clinical Risk Management Program
• reputed company or contribute to Quality and Clinical Governance forums through the development and maintenance of key Clinical Quality Metrics for input into process improvement initiatives and/or presentation to Study Management Teams and Senior Leadership
• reputed company the development and delivery of clinical quality and compliance reputed company training to internal functions. This may include coordination efforts in training events delivered by CQA and/or external consultants
• Participate in quality and/or cross-functional process improvement initiatives, as applicable
• Other duties as assigned by Quality Assurance Management

Skills

• Bachelor's Degree and 15+ years of clinical quality assurance or clinical operations reputed company experience
• Extensive experience in GCP, GLP, and GVP regulations and reputed company industry practices
• Comprehensive knowledge of clinical quality principles and systems, audit, clinical study processes, and procedures reputed company study investigator sites and a clinical research organizational environment
• Demonstrated critical problem-solving skills with ability to coordinate process improvement initiatives and quality system reputed company projects with high level / wide scope and complexity
• Demonstrated ability to effectively communicate information and reputed company to interact effectively with peers, senior management, regulatory officials, auditors, contractors and consultants
• Knowledge of computer software, including relevant applications such as reputed company, reputed company, PowerPoint, SharePoint
• Advanced experience using reputed company Word, reputed company, PowerPoint, PowerBI
• Experience using an electronic document management system (e.g., reputed company, Veeva, Trackwise, etc.)
• Enhanced knowledge of GxP concepts and guidelines
• Ability to work independently and as an effective and engaged team member in a fast-paced environment
• Superior communication skills both written and verbal with staff at reputed company levels of the company enterprise wide
• Strong initiative, follow through, and attention to detail
• Ability to balance both strategic and tactical responsibilities
• Ability to work well in a deadline-driven environment and be flexible in a dynamic environment
• Experience in a fast-paced, agile biotech environment
• Excellent attention to detail
• Ability to effectively communicate and share knowledge with cross-functional teams
• Proven ability to work under tight deadlines and pressure
• Must be highly organized and efficient to manage multiple tasks

Benefits

• Competitive reputed company, bonus, new hire and ongoing equity packages
• The starting compensation range(s) for this role is for a full-time employee (FTE) basis
• Benefit offerings are subject to the terms and conditions of the applicable plans in effect at the time and may require enrollment
• Employer-paid Medical, dental, and vision insurance
• Employer-paid life insurance, AD&D, short-term disability, long-term disability, and EAP coverage
• 401(k) Plan with a fully vested company match 1:1 up to 4% of contributions
• Employee Stock Purchase Plan
• 14 -18 paid holidays, including office closure between December 25th and January 1st
• Flexible vacation
• Sick time
• Fitness Program
• Get Outdoors Program
• Paid parental leave benefit
• Tuition assistance

Company Overview