Senior Compliance Consultant (REF7179Q)

Job Description

This Senior Compliance Consultant position is responsible for independently managing compliance related projects and providing consulting and contract services to clients for quality related issues and regulatory/GMP, as needed. This position will be subject matter lead for assigned quality assurance and regulatory/GMP compliance projects within ProPharma Group.

Essential Functions Include:

1. The Sr. Compliance Consultant will be subject matter lead for specific quality assurance and regulatory/GMP compliance projects within the company.2. Promote continual improvement regarding customer satisfaction with emphasis on quality and compliance services.3. Keep pace with advances and technological changes in Compliance Services and the pharmaceutical / device / biotech industries, and promote those that will increase the company’s effectiveness and profits.4. Provide support to clients and all functional units of ProPharma Group as quality and regulatory compliance issues such as deviations and non-conformances arise. Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for helping to ensure compliance of company operations to quality principles and GMP requirements, and participation in the development of quality systems through SOP writing and training.5. Promote Quality and Compliance subject expertise through publications and presentations through professional networks.6. 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.7. Help to ensure the Compliance practice is in compliance with all applicable internal and external policies procedures, and industry best practices.8. Generate of proposals for Compliance-related projects.9. 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. Includes candidate interviewing skills.10. Audit projects for correct approach, consistency, and quality.11. Understanding of the criteria for selection for compliance consulting services in the pharmaceutical, medical device and biotech industries.12. Knowledge of the sales process in these industries.13. Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.14. Quality orientation and high attention to detail.15. Demonstrated ability to lead people and get results through others.16. Strong working knowledge of cGMP regulations, USP standards, and ICH and FDA guidance documents.17. Utilize expertise of quality systems and GMP compliance to conduct audits and provide Gap analyses and risk assessments for clients.18. Perform Customer Service functions in response to client inquiries.19. Provide support to clients and all functional units of ProPharma Group as quality issues such as deviations and non-conformances arise. Also, provide advisement for the implementation of proper CAPA to resolve deviations and non-conformances.20. Assist with interviews of ProPharma Group candidates.21. Extensive travel required.22. Other duties as assigned.

Qualifications

1. B.S./B.A in scientific discipline as a minimum. A graduate degree in a scientific discipline is preferred.2. Minimum 10 years’ quality management experience in related industry.3. Minimum 5 years’ managing a technology business or business unit or applicable related experience.4. Ability to interact in a professional and positive manner with clients and co-workers.5. Strong editorial skills for the review and approval of GMP documentation, including protocols, reports, SOPs, etc.6. 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.7. Ability to manage and work with multiple individuals (where applicable); s in company quality program and compliance related activities.8. Ability to manage and execute multiple tasks associated within the compliance, quality assurance and validation fields.9. Exceptional communicator with strong persuasion skills and presentations.10. Excellent interpersonal and communication skills.11. High level of understanding of the criteria for selection for compliance consulting services in the pharmaceutical, medical device and biotech industries.12. Knowledge of the sales process in these industries.13. Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and directing of a project.14. Proven record with team leadership, problem solving, project tracking and budgeting, and facilitation of efficient communication between the client and the team.15. Knowledge of standard office policies, procedures and standards.16. Experience creating and working with high performance teams.17. Ability to organize and manage multiple projects.18. Quality orientation and high attention to detail.19. Demonstrated ability to lead people and get results through others.20. Ability to think ahead and prepare action plans to achieve results.21. Supervisory experience, including employee hiring and retention, performance review and discipline.22. Ability to balance and achieve positive results in the areas of safety, quality, productivity, cost and employee relations.23. Excellent analytical skills and the ability to access and resolve difficult business situations.24. Ability to take initiative, to maintain confidentiality, to meet deadlines, and to work in a team environment.25. 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.

Additional Information

Candidate 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.