Covance

  • Associate Director QA / Regulatory

    Job Location(s) IN-Bangalore | IN-Bangalore
    Job Number
    2018-18715
    Job Category
    Quality Assurance
    Position Type
    Full-Time
  • Job Overview

    In your role as Associate QA Director, you will

     

    • Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
    • Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
    • Manage allocation of QA&C staff within local region to complete the required audits and fulfill staff utilization/achievement of QA&C targets
    • Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
    • Provide local /regional leadership and line management as required

    Top 3 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.

     

    Get to know Covance

     

    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 recognised and applauded for our efforts in the creation of personalised 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 India, visit www.Covance.com/IndiaCareers

     

     

    Education/Qualifications

    Education Minimum Required:

    • 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

    Required:

    Core and Leadership Level

    • Excellent technical knowledge, understanidng an experience applying ICH/FDA / Good Clinical Practices
    • Strong analyticial skills
    • Excellent oral, written and presentation skills
    • Excellent planning and organizational skills
    • Proven interpersonal skills
    • Demonstrated ability to handle multiple competing priorities across clinical operating units
    • Ability to inspire effective teamwork and motivate staff within a matrix system
    • Ability to function as a member of a global clinical team
    • Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
    • Financial understanding of global clinical development budgets

     

    Experience

    Minimum Experience Required:

     

    4 years’ experience in Clinical Quality Assurance, preferably with GCP experience

    7 years’ experience in other professional roles within pharmaceutical/CRO  environment.. Other required work-related experiences

    • Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
    • Knowledge of the drug development process from the perspective of a contract research organization

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