Job Summary
The Senior Clinical Compliance Consultant position is responsible for independently managing compliance-related projects and providing consulting and contract services for quality-related issues. This position will be the subject matter lead for assigned areas and compliance projects within Quality Confidential.
Essential Duties
Responsible for independently managing compliance-related projects and providing Quality/GCP/Regulatory consulting and contract services to clients.
Develop, optimize, and/or manage client Quality Management Systems.
Author and/or review documents for cGxP compliance.
Keep pace with advances and technological changes in clinical trial execution and the pharmaceutical/medical device/biotech industries.
Recognize and provide quality and regulatory support for deviations/non-conformances/CAPA.
Responsible for ensuring compliance of client operations to quality principles and GCP requirements.
Support the development of policies and procedures for all applicable business units within the company.
Ensure client compliance with all applicable internal and external policies procedures and industry best practices.
Utilize expertise in quality systems and GCP compliance to support the performance of audits, gap analyses, and risk assessments for clients.
Essential Duties and Minimum Requirement
Required: BS/BA in a scientific discipline.
Preferred: Graduate degree in a scientific discipline.
Minimum 15 years of clinical quality experience.
Minimum 5 years managing clinical quality operations, including GCP auditing, protocol, and TMF review.
Strong working knowledge of international GCP regulations, ICH standards, and regulatory guidance documents.
Quality orientation and high attention to detail.
Ability to interact in a professional and positive manner with clients; earn and maintain client confidence through appropriate planning, organizing, and directing of a project.
Strong editorial skills for the review and approval of GxP documentation, including protocols, reports, SOPs, etc.
Effective written and oral communication skills; ability to write, type, express or exchange ideas by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and translate those instructions into physical execution of tasks.
Ability to manage and execute complex compliance projects.
Ability to think ahead and prepare action plans to achieve results.
Excellent analytical skills and the ability to assess and resolve difficult business situations.
Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment.
Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift reasonable weights (approximately 35 lbs.), read, prepare and analyze data for development of reports; ability to sit and type for long periods of time; ability to read and assemble documents as required.
Extensive travel may be required.
About the Company
Quality Confidential engages the industry’s best talent to offer customized compliance solutions to clients in the pharmaceutical, biopharmaceutical, and medical device industries. We work with our specialized consultants to provide personalized project planning to ensure client project goals are met. Quality Confidential prioritizes partnering with consultants who are highly skilled, experienced, and passionate about problem-solving.
OUR CULTURAL BELIEFS
Authentic Communication - I speak up to create transparent, thoughtful, and timely dialogue.
Service Excellence - I value every client experience and its impact on results.
Passionate Work Ethic - I hold myself accountable and maintain high standards.
Integrity Over Profit - I act with our clients’ best interests in mind.
Creating Partnership from the Heart - I partner with anyone, anywhere to achieve results.