The GCP Auditor serves as an in-house expert on audit-related matters, maintaining an up-to-date awareness of internal programs and external trends. The incumbent will perform a broad range of audit-related duties (e.g., planning audits, performing audits, providing QA project management, ensuring follow-up on findings, providing formal reports, and collaborating with global colleagues as needed on projects).ResponsibilitiesMaintains keen awareness of all audit-related matters (e.g., internal clinical program status, SOPs and other internal guidance, regulatory changes, industry trends): Possesses an awareness of current and planned clinical programs within. Performs QA project management to deliver agreed QA coverage of projects and activities related to assigned compound(s) Actively provides QA input to working groups and system(s) development as appropriate Provides advice on QA and GCP matters to staff Serves as primary liaison with Regulatory Affairs Dept in maintaining an awareness of ongoing regulatory changes Attends relevant conferences and seminars to maintain awareness of external QA activities Delivers the QA contribution to internal and external meetings (e.g. investigator meetings) as appropriate As requested, develops QA SOPs Provides QA review and approval of SOPs and Work Instructions Reads and maintains awareness of applicable SOPs relevant to functionPerforms Wide-ranging Audit Activities Prepares audit plans for clinical and other projects as applicable Liaises with relevant parties to arrange audits or reviews required by QA audit plans Performs audits of internal systems Prepares reports of audits performed, per SOP(s) timelines Follows up on audit observations to agreed conclusions Provides audit certificates for relevant audits Distributes relevant audit reports and documents in accordance with QA PolicyLiaises as required with internal/external counterparts on global activities and programs: Provide local US perspectives in relation to global activities and systems Liaises as required with QA representatives in other markets Hosts \"GXP\" related audits and inspections Performs other duties as requiredQualifications Bachelors degree (science major is preferred) At least seven (7) years experience as a QA Auditor of the drug development process In-depth experience with Good Clinical Practices (e.g., leading GCP audits and/or training staff in GCPs) is required Highly analytical and detailed approach; proven ability to detect and correct errors and/or inconsistences Comprehensive understanding of FDA regulations; knowledge of ICH guidance is required Excellent interpersonal and communication skills; ability to build effective relationships within a team/collaborative environment, while demonstrating a high level of professionalism Good written communications skills, including SOP/other technical writing Able to travel as required within a global work environment (approximately 10%)Physical Demands Ability to sit or stand for long periods of time Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer Ability to carry, handle and reach for objects Ability to lift and pull up to 15 poundsWhen it comes to recruiting, you need to partner with a firm that understands the current market conditions and will identify top candidates quickly. You have no time to waste and partnering with the right firm is critical to your recruitment project's success.We deliver a cost-effective, time-sensitive approach that is guaranteed!What people say about our services: \"When working with HireResources, their representatives offer centralized management of your account, which translates to a consistent, dependable and smooth partnership. They establish key performance metrics, ideal employee profiles, and fee agreements in advance so there are no surprises along the way\".
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.