Senior Consultant - Compliance
Parexel International Corporation
USA - Any Region - Home Based
Bring your Quality and Compliance expertise to Parexel's highly regarded Regulatory Consulting team!
If you love travel, are solutions focused and have previous experience in GxP inspections, QMS audits, GMP surveillance, PAIs, and excellent technical writing skills, we'd love to speak with your regarding this amazing opportunity!
A Senior Consultant must have a comprehensive understanding of the organization’s consulting models and methodologies, as well as, profound knowledge within a business context of Quality and Compliance services provided. A Senior Consultant develops specialist knowledge of a particular subject matter or market in Quality systems, Quality Assurance, Compliance and may have education and experience in pharma or device manufacturing.
A Senior Consultant provides a broad range of consulting services and works w/in project guidelines to identify, refine, and address client issues and to achieve project objectives serving either as an individual contributor, a workstream lead or provides overall project leadership. A Senior Consultant provides guidance to project team members on technical/process issues. A Senior Consultant ensures the timely performance of work w/in a project scope to the quality expectations of PC and the client. A Senior Consultant anticipates next client need and qualifies opportunity with the client or obtains introduction to other client decision makers.
-Works w/in a team environment or individually based on the project needs
-Works w/in broad project guidelines and facilitates issue and conflict resolutions
As a Project Leader, provides overall project leadership:
-Responsible for project planning and set-up and routinely
-interacts w/ the assigned Project Specialist or Project Manager to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)
-Functions as the main client contact and ensures accurate project reporting
-Ensures that the project team delivers to meet the client expectations for quality and timeliness
-Ensures that appropriate risk identification and issue-escalation procedures are in place, and leads issue and conflict resolutions
-Ensures project specific training compliance of the project team
-Manages project financials and accurate revenue forecasts
-Ensures that the project team works w/in the scope of the contract
-Identifies new opportunities or add-on business from existing work
-Ensures timely project close-out activities are completed
-May prioritize the work load of the project team to achieve the project scope
-Capitalizes on opportunities to improve project efficiency, results or team performance and takes action
- Leverages information from previous projects to complete assigned project activities and to facilitate business decisions
-Produces quality work that meets the expectations of Parexel and the client.
-Reviews the work of colleagues to ensure the expectations of the client and Parexel are met
-Provides guidance to project team members and mentors junior staff
Consulting and Relationship Management
-Demonstrates the use of the organization’s consulting models and methodologies and uses experience to suggest possible developments/improvements
-Provides a full range of technical and/or business consulting services w/in personal area of expertise dealing mainly in areas where policy or precedent is clear
-Completes activities and may delegate activities w/in project scope and objectives in a timely manner with an understanding of issues which may impact project profitability, quality, and client satisfaction
-Facilitates client decision making by framing issues, presenting options and providing objective business advice
-Collaborates and facilitates resolution of problems or conflicts.
-Provides guidance to junior colleagues on appropriate methods of executing project activities
-Acts as a trusted advisor to clients and/or project team on technical and/or process issuesQualificationsKnowledge and Experience:
8 - 12 extensive years of experience in an industry-related environment such as Quality Assurance, Quality Control, Quality Systems within Pharmaceutical, Biopharma or Medical Device; experience with a regulatory agency (such as FDA, MHRA) is a plus
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
-High-level consulting skills
-Critical thinking and problem-solving skills
-Project leadership and management knowledge
-Excellent interpersonal and intercultural communication skills, both written and verbal
-Client-focused approach to work
-Teamwork and collaboration skills
-Proficiency in local language and extensive working knowledge of the English language
-Self-confidence and control
The ability to travel up to 90% domestically and/or internationally is required EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.