Senior Quality Manager - Data Services

27 Apr 2021
27 May 2021
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Job Description

Parexel is in the business of improving the world's health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do.We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.

We are currently looking for a Senior Quality Manager to be homebased in Europe but commuting distance to one of our offices for visits as required.

In this role you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.

Additional Responsibilities
  • Manage the relationship with Operations
  • Independently
  • provide Quality input to audits/inspections
  • provide quality advice as assigned
  • develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and
    maintain inspection-ready performance
  • facilitate the Event Spotlight process for assigned areas
  • Facilitate identification, investigation and remediation of Quality Issues (QIs) as assigned
  • Maintain compliance with Parexel standards and regulatory requirements
  • Qualifications

    Knowledge and Experience
  • Significant industry experience in one or more areas of Data Services QM support and/or QualityManagement
  • Expert knowledge of ICH-GCP and clinical trial regulation
  • Expert using root cause methodologies (5-whys, fishbone diagram, etc.)
  • English proficiency (written and oral)
  • Knowledge of Biostats and Programming desirable
  • IT literate - experience with Microsoft based applications and functional and TMF applications /languages / solutions.
  • Able to embrace new technology and apply best practices
  • Education
  • Bachelor's Degree or other relevant experience required; Masters preferred. Life-science, health or industry-related discipline preferred.
  • Skills
  • Ability to lead without explicit authority
  • Self-management: independent, takes initiative, proactive and organized
  • Focused on quality results - attention to detail and First Time Quality
  • Persistent - doesn't give up!
  • Curious - asks questions, investigates issues
  • Build relationships through collaboration, stays positive
  • Client-focused - able to get to and interpret the need
  • Sees the big picture - how the pieces fit together
  • Secure interpersonal, verbal and written communication skills
  • Expert analytical critical thinker, focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions
  • Ability to develop professional, collaborative relationships both within Quality and with Operations
  • Expert skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues
  • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge
  • Ability to plan, organize others, prioritize and manage workload independently
  • Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables
  • Ability to manage the complexity of a matrix environment while valuing the importance of teamwork
  • Cultural awareness with the ability to think and work, globally
  • Ability to provide direction and mentoring to less experienced staff
  • Ability to travel as needed for the position
  • Why Work at Parexel

    There are pivotal moments in every career: Sharing new treatments. Improving processes. Delivering life-saving advances. The people who succeed are the ones who make the journey go further and faster every time. What if you had a partner to support you as you reach the next level in your professional path? A partner who believes a collaborative environment is key to achieving your goals? A partner who is dedicated to your health and wellness so you can help make a difference in the lives of millions worldwide?

    That's Parexel. We're a diverse team of professionals focused on one goal: getting treatments into the hands of those who need them most. Working together, the results we bring to our clients and the opportunities we bring to our team get better with every step.

    How can we help you on your journey? Find your path, and learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

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