PRAHS

Returning Candidate?

2017-43853

2017-43853

Title 
Director of Quality Assurance
Job Locations 
-
US-Remote
Posted Date 
11/25/2017

More information about this job

Overview

Senior Director, Quality Assurance 

 

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 14,000+ employees strong, operating in more than 85 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.

 

Who are you?

You are a mentor and leader- because being a report pusher isn’t your style!

You like to stay hands on with your audits- (our Managers up to the VP still audit!)

You are a strategic thinker with a great attention to detail. – nothing gets past you!

You like variety. – The same old tasks day to day just don’t get you up in the morning!

You have experience with a full range of audits and GxP services.

You believe in consistently delivering quality with each audit you perform.

You have experience traveling (and enjoy being on the road!) to conduct onsite audits.

At the end of the day, you want to work for a company that values your education, knowledge and experience… 

a company that is ultimately better with you on their team. 

That company is PRA.

 

Responsibilities

What will you be doing?

 

Long story short, you will manage a team of up to 5 QA staff members; still staying hands on so you can coach and mentor! This position assists in ensuring the company promotes a culture that encourages ethical conduct and a commitment to compliance, resulting in a positive image internally and to customers. This is a cross functional role that interacts with all functions of the organization.

 

Still interested?  Great, there’s more…

  • Defines strategic and functional direction, as well as team/ individual goals and expectations to ensure each QA staff member understands her/his responsibility to know and follow all SOPs and corporate policies
  • Ensures QA staff under their direction effectively executes the QA Operating Plan, including the annual audit plan, approved by senior management
  • Ensures all contracted operational and systems audits are planned, schedule, performed and results reported and documented in adherence to protocols, SOPs, regulations, GxP, and expectations for data accuracy and completeness
  • Defines future work methodologies to better meet customer needs
  • Broadly and globally interprets regulations and guidance documents governing GxP and serves as expert and consultant to PRA stadd and client representatives
  • Ensures all new and updated PRA SOPs are reviewed by QA for clarity, internal consistency and compliance with global GxPs
  • Ensures client audits and regulatory inspections of PRA are prepared and hosted to meet the client’s/inspectors’ requirements and minimize disruptions to ongoing operations
  • Actively participates in the reviewing and hiring of new QA staff and ensures new QA employees are trained and qualified to perform their tasks
  • Provides regular status reports on quality observations to Operational Management, as requested
  • Contributes to training for selected PRA functional groups related to Good Clinical Practice, clinical trials regulations, and the role of QA and PRA staff in ensuring compliance with GCP
  • Mentors and develops new QA managers
  • Provides expert quality assurance advice to Project Teams to deal with or avoid potential regulatory agency compliance concerns
  • Provides guidance and oversight in managing and responding to compliance questions and recolves compliance related issues.
  • Participates in and/or leads, as assigned, GxP-related projects initiated by internal stakeholders
  • Effectively plans, implements, and monitors QA functions; and ensures optimal utilization of billable auditing staff

You may be responsible for…

  • Oversight of Quality Assurance Tracking System to ensure that reporting, tracking, trending and analysis of non-compliance issues is performed as required
  • Investigation, management, trending and analysis of internally and externally reported non-compliance issues
  • Interactions with various PRA functions to determine needs for process improvement, corrective and preventive actions and risk based auditing approach resulting from trending activities
  • Strategic focus on Quality Assurance’s development of roles and responsibilities within company
  • Acts as deputy to Vice President Global Compliance
  • Represents the Quality Assurance Department at both internal and external meetings
  • Develops and implements the Quality Assurance operating plan
  • Manages the Quality Assurance Business Plan
  • Liaises with PRA Sales and Proposals to heighten awareness of the services the Quality Assurance department offers
  • Oversight of Training Program for audito

 

 

 

Qualifications

What will you need to have?

 

Great question…

  • More than 15 years industry experience
  • More than 10 years QA experience
  • More than 10 years managerial experience required
  • Extensive experience with operational and system auditing, compliance, and SOP development required
  • Must have thorough understanding of EU and/or US clinical trials regulations
  • Understanding of all aspects of clinical research, including protocol development, CRF design, clinical trial management (including laboratory methodologies and clinical examinations), data management, statistical analysis, clinical study reports, and regulatory submissions preferred
  • Read, write and speak fluent English; fluent in host country language required
  • An undergraduate degree or its international equivalent from an accredited institution required, science-related preferred
  • Advanced degree preferred
  • Global experience in a CRO Quality Assurance environment preferred
  • Experience performing Investigations in a GxP environment.  (e.g., GMP, GCP, etc.) 
  • Experience working with various Root Cause Analysis (RCA) techniques
  • People management experience 
  • GMP & GCP experience - preferred 


PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

Options

Share on your newsfeed

Connect With Us!

Not ready to apply? We get it! Click here to stay in touch for future opportunities, events and other happenings!