the smart solution for Washington DC jobs

Clinical Quality Manager (GCP)

Company: Beacon Hill Staffing Group - Pharma
Location: Arlington
Posted on: June 14, 2018

Job Description:

Plan and lead GCP audits (international and domestic), including clinical investigator sites, contract clinical laboratories, and CROs to determine compliance status and identify compliance risks. Assess GCP compliance risk areas and develop and implement risk mitigation measures. Ensure compliance with companys procedures and regulatory requirements. Conduct QA reviews of project-related Clinical Development essential documents (e.g. protocols, amendments, case report forms, tables and listings, informed consents, investigator brochures, and Clinical Study Reports). Review and provide input in to non-clinical documentation (e.g. protocols, study reports). Facilitate GCP training of functional areas and develop appropriate training for personnel involved in the execution of clinical trials and nonclinical studies. Participate in the evaluation and selection of CROs and other clinical and nonclinical service providers. Provide guidance, interpretation and information on GCP regulations, standards and quality systems. Develop and implement standards, policies and procedures for GCP regulatory compliance. Develop and measure quality metrics to drive consistent quality standards relating to GCP activities. Experience, Education and Specialized Knowledge and Skills Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks. Masters Degree preferred with minimal 10 years experience in Biotech or Pharma and 5+ years experience in Quality Systems related to GCP. Strong analytic skills with practical knowledge of how to identify key performance quality metrics to set targets for maintaining a state of compliance while identifying areas for improvement. Extensive experience auditing clinical CROs, clinical sites and investigator sites. Understanding of domestic and international regulatory requirements. Outstanding communication skills (interpersonal, verbal and written). Proven track record of industry success. Strong leadership and management skills. Excellent teamwork and collaboration skills. Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

Keywords: Beacon Hill Staffing Group - Pharma, Washington DC, Clinical Quality Manager (GCP), Executive, Arlington, DC

Click here to apply!

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

I'm looking for
in category

Other Executive Jobs

Junior Program Manager
Description: A position is currently available for a Junior Program Manager for support of Missile Defense Agency MDA and Navy programs. Candidate will serve as the deputy program manager for several MDA and Navy (more...)
Company: Telephonics
Location: Columbia
Posted on: 06/20/2018

Account Manager B2B
Description: Job DescriptionL23 Networks is an innovative Telecommunications Technology Sales and Marketing company. We are actively seeking to fill the role of Business to Business Account Manager who will take our (more...)
Company: L23 Networks
Location: Bethesda
Posted on: 06/20/2018

Associate Director, Crisis & Litigation
Description: We have an immediate opening for an Associate Director to join our Crisis Management and Litigation Communication CMLC practice, headquartered in Washington, D.C. br br RESPONSIBILITIES br br (more...)
Company: APCO Worldwide
Location: Washington
Posted on: 06/20/2018

HUMINT Collection Manager with Security Clearance
Description: This position is contingent upon government funding and award of contract to Clear Resolution Consulting, LLC JOB SUMMARY: -- CRC has a need for multiple HUMINT Collection Managers to provide operational (more...)
Company: Clear Resolution Consulting, LLC
Location: Washington
Posted on: 06/20/2018

Human Resources Manager, Enterprise
Description: Our Purpose br Improbable is dedicated to building powerful technology designed to help solve previously impossible problems and enable the creation of new realities. Improbable unlocks truly next-generation (more...)
Company: Improbable
Location: Washington
Posted on: 06/20/2018

Director, Americas Public Sector Marketing
Description: Company Overview br WHERE WILL YOU DO YOUR BEST WORK br Riverbed solutions help companies transition from legacy hardware to a new software-defined and cloud-centric approach to networking and application (more...)
Company: Riverbed Technologies
Location: Reston
Posted on: 06/20/2018

Description: Requisition Number br 17-0136 br br Post Date br 12/8/2017 br br Title br QUALITY MANAGER br br City br SPRINGFIELD br br State br VA br br Description br Versar, Inc. (more...)
Company: Versar, Inc.
Location: Springfield
Posted on: 06/20/2018

Pain Management Physician - Physicians Only Apply - Perm
Description: A Pain Management Physician practice is seeking a qualified physician for Washington, DC. This and other physician jobs brought to you by Registered Profile Required br br br Telemedicine Clinicians (more...)
Company: RediDoc
Location: Washington
Posted on: 06/20/2018

Territory Sales Manager Business Development-Northern Virginia (Diversity candidates)
Description: Who We Are:Guest Supply is a leading global manufacturer and distributor to the Travel and Leisure industry, providing products to over 25,000 hotels in 88 countries. Rapidly approaching a billion dollars (more...)
Company: Sysco Guest Supply, LLC
Location: Springfield
Posted on: 06/20/2018

Shift Manager - 1458 - Lenfant Plaza - Washington, DC (Washington, DC)
Description: Like the bottom bun of a burger, Five Guys offers a solid foundation At Five Guys, we serve outstanding burgers and fries, in clean restaurants with a top tiered customer service approach If you can lead, (more...)
Company: Five Guys
Location: Washington
Posted on: 06/20/2018

Log In or Create An Account


Forgot password?

Find us on Facebook

Find us on LinkedIn