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Senior Manager R&D QA

Posted on Sep 14, 2021 by Puma Biotechnology Inc

Los Angeles, CA 90189
Immediate Start
Annual Salary

This position will work to ensure the quality and compliance of Puma-sponsored clinical trials and other clinical activities. This will be done primarily through Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GPvP) oversight of clinical quality across the company. The successful candidate will be able to: (1) oversee responsibilities of GCP consultants and external auditors; (2) coordinate, schedule and prepare for audits in accordance with established QA goals and objectives; (3) communicate with internal departments of upcoming audits and schedule the audits in cooperation with personnel from Clinical Operations and other relevant internal departments/functions, as well as external vendors and investigator sites; (4) effectively conduct the audits, draft Audit Reports, and submit these Reports to QA management for review and input; (5) assist in inspection readiness activities; (6) attend Clinical Trial team meetings; (7) remain current with new/revised global regulations/guidelines; and (8) develop and conduct GCP training.

Major Duties/Responsibilities
- Maintain a working knowledge of current FDA and ex-US (eg EU and ICH) regulations and guidance governing GCP, GLP, and GPvP
- Coordinate, develop, maintain, and/or deliver GCP training programs
- Assist QA management in ensuring the quality and compliance of Puma's clinical development and clinical operations activities with respect to internal procedures and global (eg FDA, ICH, EU and other country-specific) regulations
- Communicates significant deviations or other compliance issues to QA management
- Establishes contract agreements and Statement of Work (SOW) documents with contract auditors according to the internal processes
- Conducts QA review of draft protocols, Informed Consent Forms, Clinical Study Reports, and other clinical trial-specific documents
- Conduct or coordinate audits of central labs, specialty labs (eg biomarkers, ECG [central] readers), other vendors (eg CROs, pharmacovigilance-specialty and EDC vendors,) and investigator site audits
- Create, review, and follow internal SOPs
- Support the preparation, coordination, and management of regulatory agency inspections, including sponsor/monitor inspections and clinical investigator site inspections, and provide expertise and assistance to other departments, as required
- Represent Quality Assurance at meetings, and communicate requirements for compliance with applicable regulations and quality best practices
- Provide support to Clinical Operations at Investigator Meetings
- Evaluate and utilize trends and available metrics to identify gaps or opportunities for improvement; track and provide reporting on CAPA execution and other available metrics
- Support the organization in maintaining a work environment focused on quality and that fosters respect, open communication, collaboration, and teamwork

Skills and Abilities
- At least 8 years of proven experience in clinical compliance or clinical quality assurance, including the conduct/coordination, reporting and closing audits (vendor, document, database, and investigator site)
- Effective written and verbal communication skills, with the ability to communicate clearly and concisely
- Good understanding of the Clinical Development Process
- Strong SOP writing experience within the GCP area
- Strong interpersonal skills, team player, and flexible without compromising quality
- Comprehensive knowledge of global regulations related to the clinical development process, including GCP, GLP and GPvP regulatory requirements, and their practical implementation
- Ability to take ownership of specific projects, and to effectively work with cross-functional team members on projects
- Skilled in methods of discovery, root cause analysis, improvement/correction planning and implementation
- Ability to travel domestically and internationally for conducting audits of clinical vendors and clinical investigator sites
- Ability to establish collaborative working relationships with internal and external stakeholders
- Self-motivated and able to effectively prioritize and manage multiple projects and tasks in a fast-paced environment, with the ability to meet fast-track timelines
- Excellent time and project management skills

Physical Demands
- Ability to be productive and successful in a busy work environment
- Subject to extended periods of sitting, reading, computer work, and moderate noise levels
- Requires travel, both domestic and international, typically 30% or more as business needs dictate

Job Qualifications
B.S. degree in a scientific discipline

8-10 years of demonstrated experience working within the clinical, regulatory, or quality environment in the pharmaceutical or biotechnology industry, with specific experience in GCP/GLP/GPvP quality assurance auditing and their respective regulations
Comprehensive working knowledge of local, state, federal, and international regulations pertaining to GCP, ICH guidelines, and HIPAA requirements
Complete and thorough understanding of global GCP regulatory requirements (eg US FDA, European Union etc.)

Special Training
- Auditor training or certification
- Prior experience in regulatory inspections

Reference: 1319639310

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