Listing Info

TheSr. Quality Auditoris an experienced quality professional who will take a leading role in revising and improving internal policies and procedures as they related to quality assurance and regulatory compliance needs.The Sr. Auditor will utilize their strong interpersonal skills to focus on problem solving, listening objectively and openly to others' ideas and contributing to building a positive team spirit.As a change agent, the Sr. Quality Auditor will use their ability to build group consensus and commitments to goals and objectives.The ability to express oneself clearly, concisely and tactfully will be used in establishing effective working relationships with all employees of the organization and relevant external parties.The Sr. Quality Auditor will be focused on continual quality and process improvement.

Major Responsibilities

• Work closely with the Director, Quality & Regulatory Compliance in revising/improving internal policies and procedures as they relate to quality assurance/regulatory compliance needs
• Assist in the development, implementation, and administration of corporate quality and compliance SOPs ensuring the operations of the organization are in compliance with all applicable regulations and corporate requirements and expectations
• Manage external audits (including; investigational sites, system or operational qualifications and audit of HD preferred vendors) according to client expectations and SOPs
• Act as lead auditor and GCP Consultant for assigned projects
• Plan and ensure audits are scheduled as required by contracts and timelines
• Conduct audits to identify non-conformities in adherence to protocols, SOP, regulations, GCP, and expectations for data accuracy and completeness
• Effectively communicate findings to various staff levels and ensure clear understanding of deficiencies (verbal and written)
• Collect, report, and track responses;corrective actions and/or preventive actions
• Ensure closure of audits is documented appropriately
• Host client and regulatory audits to ensure that auditors/inspectors receive access to needed documentation and staff with minimal disturbance to day-to-day HD operations. Provide requested information while preserving the sensitive confidential information of the organization
• Manage assigned studies/projects and provide consultative services to all HD support staff regarding compliance issues and provide proactive recommendations/suggestions while assuring adherence to regulatory requirements. Serve as a contributing member of HD project teams providing consultation on quality control methodology, and providing regulatory compliance and quality assurance services
• Work closely with clients, vendors and HD staff; extending superior customer service while facilitating their needs and representing the organization with a high level of integrity and professionalism
• Plan and deliver the training for new hires, existing staff and clients as needed/contracted
• Stay abreast of current government requirements and industry practices related to GCP practices by attending seminars, training sessions, reading journals and GCP reference materials and/or obtaining required certifications. Interpret regulations and guidance documents governing GCPs and serve as expert to staff and clientsResearch published information, interacts with other QA/regulatory compliance professionals to maintain knowledge of current expectations, new trends and proposed changes to regulations
• Perform other duties as required and assigned by Director, Quality and Regulatory Compliance. These may, on occasion be unrelated to the position described above

• Bachelor's degree in related field required
• Minimum of 8 years total experience in the pharmaceutical industry required
• At least 3 years of QA Auditing experience required; to include experience in assessing regulatory compliance of clinical documentation, investigational sites and vendors
• Practical knowledge of federal regulations concerning GCPs; 21 CFR Parts 11, 50, 56, 312, 45 CFR Parts46, 160, 164, ISO 14155 guidelines and FDA, OHRP, DoD,ICH,, regulatory requirements
• Must have intermediate to advanced proficiency in MS Office
• Must possess excellent verbal and written communication and presentation skills
• Ability to multitask, work in demanding situations, meet strict deadlines and work independently

• Ability to travel up to 30%