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Are you ready to make your mark in the healthcare industry by taking your work seriously, demonstrating empathy, and acting With Heart®? When our values align, there's no limit to what we can achieve. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top-selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. We're not just the people with expertise, we're the people With Heart®.

Quality Manager, Safety Services, Quality Management

Job ID 76054BR USA - Any Region - Home Based
Home Based, US

As a Quality Manager in Safety Services your 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.

Manage the relationship with Operations
  • Establish and maintain strong partnerships with Operational management assigned partners (likely at Director levels), other Quality and business functions (e.g. Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance
  • Deputize for the Head of the PQRM group as assigned, representing specific topics
  • Provide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g. via metrics, reports, meetings attended / chaired)
  • Represent PQRM at management meetings both within Parexel Quality, Operations and externally where assigned
  • Promote / champion the Quality Management System within both the group and the Operational teams via Operational management
  • Provide input to Quality Forums to facilitate meaningful discussion that leads to action on key risk areas
  • Propose, lead and implement PQRM initiatives to accomplish PQRM’s goals
  • Support development and implementation of strategy
  • Perform other Quality related tasks as assigned
Independently provide Quality input to audits/inspections
  • Support audit/inspection preparation including helping team set priorities and reviewing key documents
  • Provide onsite (office) or remote support as needed
  • Lead project team to investigate more complex issues and root causes
  • Facilitate development of robust CAPA for more complex issues
  • Review audit/inspection responses prior to final QA review if necessary
  • Serve as an eQMS SME
Independently provide Quality advice as assigned
  • Respond to consultancy requests to enable project teams to deliver first-time quality
  • Review and approve SOP deviations using ICH-GCP, Parexel processes, regulatory requirements
  • Consult SMEs including other quality experts when necessary to resolve issues
  • Act as SME on functional topics and Quality expectations, ensuring adequate input to SOP creation / revision
  • Act as a consultant to operations on the QMS and applicable regulations
  • Identify continuous improvement opportunities and champion implementation
Facilitate identification, investigation and remediation of Quality Issues (QIs) as assigned
  • Ensure triage of relevant quality issues in electronic quality management system (eQMS) ensuring appropriate classification, as assigned
  • Where assigned as QM Representative, assist QI Manager on more complex QIs in; Supporting initial assessment of Serious Breach of GCP, developing containment actions, facilitating QI team to investigate root causes, facilitating development of robust corrective and preventive actions (CAPA) assessing effectiveness of CAPA as necessary with QI team and action owners
Independently develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance
  • Provide consultancy, to ensure efficiency and regulatory compliance of proposed approaches when not following Parexel standards
  • Audit/inspection support: Represent Parexel Quality and ensure the partnership /project team are prepared for audit, supported throughout and reviewing audit responses
  • Develop plans for the team to investigate specific process or account risks
  • Support/lead complete assigned Risk Evaluations including; identifying relevant questions & identifying project types to use during the assessment, ensuring Operational Leadership buy-in to the approach and the questions, supporting others performing evaluation, discussing the results, defining suggested actions and providing input to a presentation of the results


  • 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
  • Secure interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
  • Secure analytical critical thinker, focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions
  • Secure 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
  • 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 work independently and take initiative to meet or exceed the team goals
  • Ability to provide direction and mentoring to less experienced staff
  • Ability to travel as needed for the position
Knowledge and Experience:
  • Secure knowledge of ICH-GCP and clinical trial regulation
  • Secure experience using root cause methodologies (5-whys, fishbone diagram, etc.)
  • English proficiency (written and oral)
  • Significant industry experience in one or more areas of PQRM support and / or Quality Management
  • IT literate - experience with Microsoft based applications and functional and TMF applications / languages / solutions. Able to embrace new technology and apply best practices
  • Bachelor’s Degree or other relevant experience required; Masters preferred. Life-science, health or industry-related discipline preferred.
Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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