Covance

  • Head QA Clinical QA&C

    Job Location(s) CN-Shanghai | CN-Beijing
    Job Number
    2018-23900
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world.  Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

     

    Over the years we have been recognized and applauded for our efforts in the creation of personalized medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

    • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”
    • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award
    • IMDiversity – Corporate Diversity Honor Roll
    • Flexjobs – Top 100 Remote Work – Company to Watch
    • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”
    • To learn more about our exciting opportunities in China, visit www.Covance.com/ChinaCareers

       

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    • In your role as Clinical Quality Assurance & Compliance Head for China, you will:

       

      1. Provide leadership for core functions within Clinical Quality Assurance & Compliance (GCQA&C) in China: regulatory inspections & client audits, internal audit program, issue escalation/CAPA management, and client engagement. Specifically,
        • Oversee the client audit and inspection program in China to assure appropriate planning, support, and follow up and to assure global visibility to outcomes and management
        • Oversee execution of the China Quality Assurance Audit Program, assuring alignment with global quality strategies, reporting of results/outcomes, ensuring adequacy of corrective and preventive actions (CAPA) to address issues and, trending of audit findings
        • Oversee China QA-QA interactions with Clients in support of contracted QA Activities, partnership QA activities (working with global QA Leads) quality plans, issue escalation and notification, corrective and preventive actions to client-specific issues and quality governance  
        • Partner with Global QA&C Leadership to ensure alignment of China CQA&C operations to global standards and continuity across the Quality Management System
        • Manage and develop the CQA&C staff in China to assure nimble, and flexible quality structure able to support Clinical Development Services objectives in China effectively
      1. Partner with China CDS internal and external stakeholders to develop strategies for driving a quality mindset, inspection readiness, regulatory compliance solutions, and/or to promote & support continuous improvement initiatives, as appropriate 
      2. Provide regulatory compliance information, advice, support and training to functional and project teams and clients
      3. Support China CDS efforts to build a strong regulatory intelligence network and to systematically assess new regulatory requirements / advise CDS through implementation

      Top reasons you should join us:

       

      1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.
      2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.
      3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.
      4. Working closely with global QA team
      5. Strong commitment from global QA&C organization to build local China QA&C talent
      6. New, spacious building that houses all the Covance operations in Shanghai
      7. Role plays a bridge between global QA&C organization and local China team

    Education/Qualifications

    • University/college degree, BA/BS (life science preferred) or equivalent experience Preferred
    • Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or Equivalent experience
    • Proficient Mandarin and English speaking, fluent in writing and reading

    Experience

    Required:

    • 12-15 years’ experience in a regulated environment (e.g., GxP) in roles of a related discipline (e.g., QA, Operations, Project Management) with a minimum of 7 years in the GCP audit arena and 5-7 years of supervisory experience of equivalent experience. 12 years’ experience in pharmaceutical /CRO industries or equivalent experience.

    Preferred Capabilities:

    • Proven ability to understand, analyze and communicate the impact of global and country regulatory issues affecting the drug development process
    • Thorough knowledge of global clinical development processes, ICH-GCPs, regulatory requirements (local and global) and budgeting
    • Strong interpersonal and proven influencing and collaboration skills
    • Proven personnel management and project leadership experience
    • Strong analytical skills
    • Excellent oral, written and presentation skills
    • Excellent planning and organizational skills
    • Demonstrated ability to handle multiple competing priorities across clinical operating units
    • Ability to align and collaborate across disciplines and various levels of management
    • Ability to inspire effective teamwork and motivate staff within a matrix system
    • Ability to function and partner as a member of leadership team

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