Quality Manager

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 Data Services 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
• Contribute to critical issue resolution by providing expert quality advice and direction
• 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
• Review and investigate possible SOP deviations as requested
• Represent Parexel Quality at client or internal meetings
• 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, facilitate the development of recommendations and champion implementation
• Maintain industry awareness including future technology, business, Quality and regulatory direction and take initiative in sharing relevant information. Translate for Parexel’s use
• Provide feedback via the appropriate channel when gaps or issues are identified with Parexel processes
• Propose ideas to PQRM leadership related to departmental efficiencies, potential improvements, or innovations
• Escalate issues to Leadership as necessary

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
• Use available tools and methodologies
• Serve as an eQMS SME
• Escalate issues to Leadership as necessary

Independently develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance:

• Maintain understanding of Parexel SOPs and Partnership expectations - and how they interact
• Provide consultancy, to ensure efficiency and regulatory compliance of proposed approaches when not following Parexel standards
• Sharing of Quality information and analyses, internally (e.g., QI reports)
• Be a consistent internal point of contact within Quality. Facilitate provision of support from the wider Parexel Quality organization / Quality Management System as needed
• Audit/inspection support: Represent Parexel Quality and ensure the partnership /project team are prepared for audit, supported throughout and reviewing audit responses
• Quality Issue support: Be assigned as QM Representative on Partnership QIs

Independently facilitate the Risk Evaluation process

• Work with Quality and Operational management to identify risk areas
• 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
• Confirm agreed mitigations have been integrated into departmental plans
• Encourage documenting lessons learned
• Assess effectiveness of mitigations with management

Maintain compliance with Parexel standards and regulatory requirements

• Comply with required training curricula
• Take part in personal goal setting and performance review activities
• Accurately complete timesheet as required
• Submit expense reports as required by SOP
• Update CVs and sign JD as required by SOP

Comply with Parexel processes, ICH-GCPs and other applicable requirements

Experience Level

Mid Level