Supervisor- Pharmaceutical Quality & Reporting

Covance Inc Located in: Chantilly,  Virginia
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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.
  • 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.
  • 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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Covance Inc. is proud to be the only drug development company with a full range of research and development services—from lead optimization, to commercialization and life cycle management. Covance, headquartered in Princeton, NJ, is the drug development business of LabCorp with global operations in more than 30 countries.


Seniority Level:
Experienced - Not Management
  Quality,  R&D / Science,  Laboratory
Preferred Industry Background:
Managing a team of:
Required Travel:

Base Salary:
Other Compensation: