Suppliers, please ensure any candidate submitted to this req receives the below in its entirety:
This position will be responsible for the oversight and the conduct of audits as they relate to Good Clinical Practice (GCP) and Good Laboratory Practices (GLP), to ensure compliance of Specialty Brands clinical trials with all established regulatory guidelines as well as company policies and procedures. The position currently reports to the Vice President Quality, ARD.
o Develop Quality Assurance Plans for assigned Clinical Programs/Projects; Understand the phases, processes and techniques used to execute a Quality Assurance Plan
o Represent GCQ in assigned Project Team Meetings.
o Manage and perform audits of Investigational sites, as well as, assessments/qualification of vendors (such as Contract Research Organizations (CRO), Specialty Vendors, Laboratories for Non-Clinical (GLP), including associated documents, according to plan.
o Perform audits of Investigator Brochures, Study Reports, Clinical Investigational Sites, and Study/Trial Master Files to assure compliance with study procedures, GCP, and regulatory standards.
o Communicate audit outcome with applicable Clinical Operations team member(s) to include request for additional information for clarification, secure incomplete data items and resolution of discrepancies.
o Effectively and accurately document audit findings by generating an audit report, or other Quality Assurance summaries and obtain responses in a timely fashion.
o Follow-up on all open audits until closure.
o Evaluate audit responses for compliance with applicable guidelines, regulations, and Standard Operating Procedures/Policies.
o Discuss remediation when responses are unacceptable with manager. Execute the remediation plan as applicable.
o Follow up on corrective and preventive actions to ensure continuing effectiveness.
o Create and maintains audit files for GCQ.
o Review clinical trials data for consistency, and completeness. Communicate and discuss findings with manager to ensure accuracy.
o Provide QA Review of Regulatory documents being submitted to Regulatory Authorities to ensure compliance to the standards of Good Documentation Practices (GDP), GCP and applicable regulations.
o Provide departments with industry updates, by use of internet, publications, references, etc.
o Assist with hosting regulatory agency inspections (e.g. Runner, Scribe).
o Capable of contributing to effective SOPs, Checklists, Templates, Quality Assurance Reports and training materials.
o Bachelor degree required.
o Minimum of five years pharmaceutical clinical research, monitoring, medical writing and/or data management experience.
o Clinical QA auditing experience, GCP/GLP auditing experience is desired
o Sound awareness and understanding of the pharmaceutical business, especially with regard to the Quality, Compliance and regulatory requirements of clinical development
o Demonstrated proficiency within ICH GCP E6/8 (Good Clinical Practices (GCPs)), 21 CRF, Good Laboratory Practices (GLP), quality systems (SOPs) and audit procedures.
o Familiarity with current and pending FDA regulations.
o Knowledge of other Regulatory Authorities regulations are a plus (e.g. EMEA, MHRA, TGA, etc.) Knowledge of Good Manufacturing Practices (GMP), Good Pharmacovigilance (GPvP), EU Directives, Health Canada or other non-USA Regulations, is a plus
o Thorough understanding of clinical practices ( Clinical Trial Phases (Phase I, II, II and IV))
o Possesses the necessary science education and knowledge to manage related clinical trials and to assure ethical treatment of subjects.
o Understands medical terminology and is familiar with standards of care and disease states.
o Has some knowledge of applying principals of 21 CFR Part 11 to clinical systems.
o Must be able to manage and coordinate all tasks assigned and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
o Good organizational skills
Must be able to prioritize work effectively to meet timelines.
o Proficient computer skills
Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members.
o Good mathematical and analytical skills.
o Attention to detail.
RELATIONSHIP WITH OTHERS:
o Ability to work without supervision.
o Ability to work across functions and with team members not co-located
o Possess the ability to work in a team-based environment, either as the lead or support auditor. Alternatively, the candidate will have worked within Clinical Operations and have interacted with GCQ auditors and have a full understanding of the expectations, and differences.
o Communicate with other Auditors and Clinical Operations team member(s) to resolve discrepancies in data, request clarification and secure incomplete data items
o Must professionally, clearly, concisely and consistently communicate to external and internal customers via phone, e-mail, fax, and written documents. Must also be able to demonstrate professional presentation skills to deliver fair balanced presentations and, when applicable, facilitate resolution of differing opinions.
o Must be able to adapt to other personalities in a respectful manner that is conducive to goal achievement and team building
o Must be able to be driven, engaging, trustworthy, collaborative and quality driven individual with a high regard to integrity.
o Ability to travel primarily domestic travel - Minimum 25%
o Ability to multitask and adapt to changing priorities
Capable of planning activities to meet GCQ objectives
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering