Quality Specialist II

Job Purpose: 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.

• The Quality Specialist II will assist with establishing and maintaining a strong partnership with Operational management assigned partners, other Quality and business functions (e.g. Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance. Provide input to Quality Forums, to facilitate meaningful discussion that leads to action on key risk areas. Support audit/inspection preparation including helping team set priorities and reviewing key documents. 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. Where assigned as QM Representative, assist QI Manager in; developing containment actions, facilitating QI team to investigate root causes, facilitating development of robust corrective and preventive actions (CAPA) and assessing effectiveness of CAPA as necessary with QI team and action owners using available tools and methodologies. Work with Quality and Operational management to identify risk areas. Complete assigned Risk Evaluations

Manage the relationship with Operations, with Line Manager or experienced PQRM assistance

• Assist with establishing and maintaining a strong partnership with Operational management assigned partners, other Quality and business functions (e.g. Risk Management, Project Quality & Risk Leads) and with Line Manager to ensure continuous improvement and regulatory compliance
• Provide transparency to compliance with quality expectations (and defining those expectations) to Operational management (e.g. via metrics, reports, meetings attended / chaired)
• 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
• Contribute to initiatives to accomplish PQRM’s goals
• Perform other Quality related tasks as assigned

Provide Quality input to audits/inspections with Line Manager or experienced PQRM assistance

• 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 root causes
• Facilitate development of robust CAPA
• Review audit/inspection responses prior to final QA review if necessary
• Contribute to critical issue resolution by providing expert quality advice and direction

Provide quality consultancy as assigned and with LM or experienced PQRM assistance

• 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
• 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

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 in;
• 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

Develop and cultivate transparent quality relationship on assigned Partnerships, to achieve and maintain inspection-ready performance, with Line Manager or experienced PQRM assistance

• 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 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

Facilitate the Risk Evaluation process

• Work with Quality and Operational management to identify risk areas
• Complete assigned Risk Evaluations including; support with identifying relevant questions & identifying project types to use during the assessment, 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

Maintain compliance with Parexel standards and regulatory requirements

Skills:

• Self-management: independent, takes initiative, proactive and organized
• Focused on quality results - attention to detail and First Time Quality
• Interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Emerging skills as an analytical critical thinker, focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions
• Skill 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 travel as needed for the position Knowledge and Experience:
• Knowledge of ICH-GCP and clinical trial regulation
• English proficiency (written and oral)
• 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