Covance

Supervisor- Pharmaceutical Quality & Reporting

US-VA-Chantilly
Job Number
2017-16067
Job Category
Other
Position Type
Full-Time

Job Overview

Covance is seeking a Supervisor- Pharmaceutical Quality & Reporting for their BioAnalytical department. The incumbent must have at least 1-2 years of people management experience and 5-6 years of related experience within the pharmaceutical industry.

 

This position is located in Chantilly, VA.

  • Schedules staff and assigns resources.
  • Drafts protocols, amendments, and study schedules, using proposal outline or client-supplied information.
  • Reviews study compliance against protocol, SOP and regulatory agency guidelines.
  • Communicates and interacts with study tACeam, other departments and clients as applicable.
  • Serves as the primary contact in communication and interaction with other departments and clients as applicable.
  • Suggests revisions to standard report/table templates.
  • Plans, prioritizes and manages team workload and other responsibilities as assigned.
  • Utilize project tracking systems as appropriate.
  • Leads or assists Project Manager with pre-initiation and other study related meetings as required.
  • Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
  • Manages increasingly complex projects and study designs and/or increased study load.
  • Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
  • Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
  • Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
  • Responsible for report production processes through finalization, including archival of data as appropriate.
  • Assists in meeting project goals within project, time and budgetary constraints.
  • Leads or assists with routine client visits as requested.
  • Actively promotes a team environment.
  • Leads or assists with team or departmental process improvement initiatives.
  • Manages data transfer to clients as requested.
  • Schedules study phases in coordination with PM and lab operations.
  • Responsible for departmental on-time reporting and cycle time metrics.
  • Assures staff compliance to SOPs and other regulatory agency guidelines.
  • Develops appropriate training plans to ensure staff is trained.
  • Acts as a mentor to other staff.
  • Reviews project hour estimates; compiles and provides revenue and forecast information to appropriate Covance staff, as applicable.
  • Performs general human resources responsibilities, including recruitment activities, performance evaluations, and progressive discipline.
  • Establishes and leads teams to identify process improvement opportunities, recommends solutions, and implements action plans.

Education/Qualifications

  • BS/BA degree in Science, or equivalent degree plus 5-6 years of related experience and 1-2 years management experience.
  • Experience may be substituted for education.
  • Knowledge of appropriate regulatory agency guidelines.
  • Demonstrates strong organizational and communication skills.
  • Ability to utilize word processing software, database, spreadsheet, and specialized software.
  • Skilled in concise writing. Writing should require little external review or edit.
  • Knowledge of grammar, punctuation, composition, and spelling.

Experience

  • Minimum of 5-7 years of study coordination experience or related experience.
  • Excellent communication, presentation, and interpersonal skills.
  • Excellent attention to detail.
  • Ability to prioritize and manage time.

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