CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Research Quality Assurance GVP Manager

Company: Akebia Therapeutics, Inc.
Location: Cambridge
Posted on: April 6, 2021

Job Description:

Under the direction of the Director--RQA -GVP the Research Quality Assurance Manager--provides administrative support to the Research Quality Assurance activities. Primary duties include: Word Processing-Formatting-Development of Controlled Documents (SOPs, Policies, Forms, Templates, etc.), audit reports, and training presentations; Event Coordination of Audits (internal and external), system access training sessions, general orientation, travel coordination; Administrative Support including filing of essential documents in print and electronic format, review of files for completeness and QC review checklists, maintaining department schedules and trackers for metrics, regulatory inspections and commitments, investigations, etc. Participating in cross training activities to include but not be limited to team projects and shadowing opportunities Required Skills

  • Supports internal staff in the planning and execution of the audit plan, audit coordination, contracting, initiating for training and system access, SOW completion and supports travel coordination
  • Maintains and facilitates the development and update of internal and external audit schedules
  • Track auditor use to assure that assignment leverages auditor experience on the program, ensure that auditor credentials and training are current and filed.
  • Assists management with metrics trending activities and updates to risk-based audit program
  • Facilitates the update to internal quality risk assessments supporting the audit and compliance programs
  • Facilitates searches for changes to regulatory standards and spearheads the initiative for evaluation of internal processes to identify impact and updates
  • Maintains the tracking of inspection commitments and facilitates the tracking of said commitments to completion
  • Maintains the tracking for quality issue investigations and actions
  • Maintains department tracking spreadsheets including metrics and trending, serious breach, and the master inspection spreadsheets
  • Maintains and ensure the archival of department deliverables including but not limited to audit reports, investigations, and associated materials
  • Helps to develop and format internal training materials and presentations, Schedules team training sessions (annual, periodic)
  • Supports, as needed, the preparation, conduct, and follow-up/response, and lessons learned for regulatory agency inspections
  • Acts as the primary liaison to assigned external audit vendors and contractors
  • Develop solutions to a variety of problems. May refer to established precedents and policies
  • Cross trains with senior team members on program compliance support activities related to GLP, GCP, and GVP Required Experience Basic Qualifications:
    • 5+ years of pharmaceutical or healthcare experience and experience working in PV or PV compliance/quality Preferred Qualifications:
      • 2+ years' experience in the pharmaceutical industry
      • Excellent communication and interpersonal skills
      • A self-starter, with tact and diplomacy who is able to define and prioritize tasks within a project
      • Demonstrates good judgement in selecting methods and techniques for obtaining solutions
      • Problem-solving attitude, exhibits judgement and realistic understanding of the issues
      • Excellent computer skills and proficiency including familiarity with Microsoft Office applications including Excel, Word, PowerPoint, MS Project, SharePoint etc.

Keywords: Akebia Therapeutics, Inc., Cambridge , Research Quality Assurance GVP Manager, Executive , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Accounting Manager
Description: Accounting Manager The Opportunity We're looking for an Accounting Manager, working in the Real Estate industry in Boston. Ensures accuracy of property rent rolls, financial reports, budgets and re-projections. (more...)
Company: Professional Staffing Group
Location: Salem
Posted on: 04/12/2021

Food Service Manager
Description: GROW With US br br For 30 years Hudson Group has led the way and prides itself in knowing what matters in travel retail. As airports and transportation terminals have evolved, so has Hudson Group, (more...)
Company: Hudson Group
Location: Malden
Posted on: 04/12/2021

Senior Director of Construction & Facilities
Description: This website is AudioEye enabled and is being optimized for accessibility. To open
Company: New Horizon Academy
Location: Plymouth
Posted on: 04/12/2021

Hourly Manager
Description: Restaurant Hourly Manager br br Do you want to be part of a team whose mission is to Create Great Memories by bringing Family and Friends together Year after year, we strive to be the best Friendly's (more...)
Company: Friendly's
Location: Leominster
Posted on: 04/12/2021

Director of Sales
Description: Director of Sales - Healthcare Analytics/information Services Company Overview Miga Solutions, Inc. is a healthcare information and services company transforming how hospitals (more...)
Company: Miga Solutions
Location: Plymouth
Posted on: 04/12/2021

Server/Dining Room Care Manager
Description: Overview br It makes me feel good knowing that we make the residents' lives better. We laugh with them, cry with them, sing and dance with them - we brighten their day. Working here is an unbelievable (more...)
Company: Sunrise Senior Living
Location: Plymouth
Posted on: 04/12/2021

Sr Manager Advanced Manufacturing Engineering
Description: Sr Manager Advanced Manufacturing Engineering Plymouth, MI JOB DESCRIPTIONSummary: Understand current production polyurethane chemistry throughout North America and provide support to all locations. Develop (more...)
Company: Adient plc
Location: Plymouth
Posted on: 04/12/2021

Registered Nurse - Case Manager - 13 Week Contract
Description: High-demand travel positions are open for Registered Nurses with experience working as a liaison to assist individuals and families cope with complicated health or medical situations in the most effective (more...)
Company: Jackson Nurse Professionals
Location: Plymouth
Posted on: 04/12/2021

Accounting Manager
Description: Accounting Manager The Opportunity We're looking for an Accounting Manager, working in the Real Estate industry in Boston. Ensures accuracy of property rent rolls, financial reports, budgets and re-projections. (more...)
Company: Professional Staffing Group
Location: Malden
Posted on: 04/12/2021

Case Management Travel RN - Job Id: JO03023218
Description: Next Travel Nursing is seeking a qualified
Company: Next Travel Nursing
Location: Plymouth
Posted on: 04/12/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds