Auftragsdetails

This Senior Consultant, Compliance and Quality Assurance (CQA) is responsible for independently managing clinical compliance-related projects and providing consulting and contract services for quality-related issues and regulatory/GCP nationwide, as needed. This position will be subject matter lead for assigned areas and clinical compliance projects within ProPharma Group. 

Essential Functions Include:

• Subject matter lead for specific quality assurance and clinical compliance projects within the company.
• Promote continual improvement regarding customer satisfaction with an emphasis on quality and compliance services.
• Keep pace with advances and technological changes in Compliance Services and promote those that will increase the company’s effectiveness and profits.
• Provide support to clients and all functional units of ProPharma Group as clinical quality and regulatory compliance issues such as deviations and non-conformances arise.
• Provide consultation for the implementation of proper CAPA to resolve deviations and non-conformances.
• Develop and optimize procedures and processes to help clients comply with GCP requirements and industry best practices for clinical quality operations.
• Help to ensure compliance of company operations to quality principles and GxP requirements, and participation in the development of internal quality systems through SOP writing and training.
• Promote Quality and Compliance subject expertise through publications and presentations through professional networks.
• Provide ongoing support and expertise to all personnel, assisting them in establishing goals, objectives, policies, and procedures for all applicable subsets of this business unit within the company.
• Ensure the Compliance and Quality Assurance practice is compliant with all applicable internal and external policies procedures and industry best practices.
• Support the generation of proposals for projects.
• Assist Operations in staffing client projects to enable the company to execute the strategic plan efficiently and effectively, and to meet revenue and profit goals based on personnel skills development and client needs.
• Audit projects for correct approach, consistency, and quality.
• Utilize expertise of GCP compliance to conduct audits and provide Gap analyses and risk assessments for clients.
• Perform customer service functions in response to client inquiries.
• Assist with interviews of ProPharma Group candidates.
• Other duties as assigned.

Qualified candidates must have:

• Required: BS/BA in a scientific discipline.
• Preferred: Graduate degree in a scientific discipline.
• 10 years’ quality management experience.
• 5 years’ managing a technology business or business unit, or applicable related experience.
• 5 years’ experience managing clinical quality operations, including GCP auditing, protocol and TMF review.
• Preferred: Experience as a Clinical Research Associate.
• Quality orientation and high attention to detail.
• Demonstrated ability to lead people and get results through others.
• Strong working knowledge of GCP regulations, ICH standards, and FDA guidance documents.
• Ability to interact in a professional and positive manner with clients and co-workers.
• 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 to translate those instructions into physical execution of tasks.
• Ability to manage and work with multiple individuals (where applicable); in company quality program and compliance-related activities.
• Ability to manage and execute multiple tasks associated within the compliance, quality assurance, and validation fields.
• Exceptional communicator with strong persuasion skills and presentations.
• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.
• Proven record with team leadership, problem-solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.
• Experience creating and working with high-performance teams.
• Ability to organize and manage multiple projects.
• Quality orientation and high attention to detail.
• Ability to think ahead and prepare action plans to achieve results.
• Supervisory experience, including employee hiring and retention, performance review and discipline.
• Ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.
• Excellent analytical skills and the ability to access 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.

• All candidates must be legally eligible to work in the United States.
• We are an equal opportunity employer. M/F/D/V
• ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***