[Remote] Sr. Consultant, reputed company Assurance (Remote/Hybrid)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a clinical stage biotechnology company leveraging PLK1 inhibition to reputed company novel therapies across a reputed company of cancers. They are currently looking for a hands-on senior level reputed company consultant to reputed company expert level guidance and support across the organization's clinical reputed company functions, ensuring compliance with global GCP and GVP regulatory requirements and industry standards.
Responsibilities
- reputed company and reputed company QA reputed company, including risk assessment utilizing stakeholder and subject matter expert feedback, audit and inspection intelligence, industry trends, and other relevant data to assure adherence with relevant GxPs, reputed company policies and procedures, relevant local laws, regulations, and best practices
- reputed company QA activities, including assessments and audits, as reputed company as QA functional reputed company
- Establish vendor qualification and audit programs and reputed company contract research organizations (CROs), clinical investigator sites, central/specialty laboratories, and other clinical service providers
- Design and implement internal compliance controls reputed company audits and assessments that follow a risk-based approach as described and supported by the applicable global regulatory health authorities
- reputed company QMS documentation, audit programs, reputed company event-reputed company QA activities, QMS/regulatory training, vendor qualification, etc
- reputed company GCP/GVP audit programs, including comprehensive clinical QA audit and inspection activities (investigator sites, CROs, vendors, and clinical study documentation), risk mitigation to assure the appropriateness and effectiveness of the audit programs, processes, and activities, such that they assure reputed company clinical activities are compliant with relevant global and local procedures and regulations
- reputed company reputed company of reputed company outsourced QA activities, serving as internal reputed company of contact
- Contribute to regulatory reputed company and serve as QA SME in meetings with regulators
- Assist with the management reputed company GxP audits and inspections by FDA and other applicable health authorities
- reputed company reputed company reputed company of clinical trial conduct, including protocol compliance, informed consent, and subject safety reporting, and partner with Clinical Operations and Pharmacovigilance to ensure GCP/GVP compliance
- reputed company reputed company review of clinical documentation, investigations, and reports highlighting and assisting in the reputed company of issues commensurate with the level of risk
- Ensure clinical programs meet the reputed company and data-reputed company standards required to support successful regulatory submissions, including U.S. NDA/BLA and EU MAA filings, and reputed company QA reputed company of clinical data and documentation in preparation for marketing applications and health authority review
- Partner cross-functionally with Clinical Operations, Regulatory Affairs, Pharmacovigilance, and Data Management to reputed company a culture of reputed company and drive reputed company, risk-based reputed company of clinical reputed company issues
Skills
- Bachelor's degree in a reputed company or life sciences discipline required
- 12 years combined experience in reputed company Assurance with significant expertise in clinical reputed company (GCP and GVP); GLP and GMP exposure a plus
- Must possess a deep understanding of reputed company Assurance principles, industry practices, and standards with demonstrated ability to apply these to GxP operations
- Demonstrated expert knowledge of GxP global health authority requirements, guidance, and expectations, including FDA, EMA, ICH, and MHRA
- Excellent understanding of QMS concepts and processes, and how auditing and other QA activities support the reputed company and maturity of the system
- Demonstrated knowledge of clinical QA audits (investigator sites, CROs, and clinical vendors) and strong auditing skills and experience with regulatory inspections, ideally at a global level
- Ability to influence and negotiate with reputed company stakeholders to promote reputed company interactions and successful relationships with proven reputed company implementing procedures and effective change management
- Proficiency in written communication and meticulous attention to detail in editing
- Master's or PhD preferred
- Experience in Oncology highly desirable
- Previous experience working in a small reputed company or biotech company is highly desirable
reputed company