Senior Clinical Quality Auditor

Updated: April 9, 2019
Location: Raleigh, NC, United States
Job ID: 2766

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Overview

You’re driven, resourceful, and above all else – remarkably smart.
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn’t cut it – you’ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you’re known for your good nature. You’ll fit right in at Syneos Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.

Why Syneos Health? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

Here, there’s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 organizations including all 20 of the largest global biopharmaceutical companies.

Responsibilities

This opportunity is with Syneos Health Consulting, an industry-leading consulting firm specializing in the biopharmaceutical industry providing services across a comprehensive range of key Practice Areas including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. You’ll join a team with industry focus, depth of functional expertise, and strong scientific and Quality (GXP) knowledge that is uniquely positioned to tackle highly complex business and clinical challenges to develop achievable strategies for our clients.

We are currently recruiting for a Clinical Quality Auditor to join our team. The Clinical Quality Auditor will work with project teams supporting Syneos Health's biotech and pharma clients.

Job Requirements

Primary Responsibilities:

  • Provide leadership in the conduct, reporting and follow up of regional and global QA audits, ensuring compliance to applicable SOPs, Master Audit Plan, and within specified timeframes and quality standards

  • Leads complex audits (e.g., directed, process, systems, office)

  • Provide suitable recommendations for audit observations; deliver appropriate CAPAs and follows them up through closure.

  • Escalates, as appropriate, where resolution of audit findings is inadequate

  • Proactively identifies and leads process improvement activities / SOP creation and revisions

  • Able to host client audits and able to support regulatory inspections

  • Represents Audit QA on project teams and other internal forums


 Qualifications:

  • University/college degree BA/BS related to life sciences

  • Expertise with ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs

  • Knowledge of the drug development process

  • 4 years CRO/Pharmaceutical experience

  • 4 years in a GXP quality role, including at least 2 years in a GCP quality audit role required



    Competencies: 

  • Excellent written and oral presentation skills

  • Superior MS office skills (Excel, PowerPoint, Word)

  • Excellent organization and planning skills and attention to detail

  • Proven interpersonal skills

  • Demonstrated ability to handle multiple competing priorities

  • Ability to function in a team based environment as a member of a Global Quality Team

Location:

Flexible (East Coast or Central or Remote)

Remote candidates should be flexible to come to the office for 1 – 2 weeks for onboarding

Remote candidates should be flexible to come to the office in the event of a Sponsor Inspection for the project they are assigned

Remote candidates should be flexible to come to office in the event of an important face-to-face meeting (infrequent)

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