Sr Quality Manager

Home Based, US

As a Sr Quality Manager you will assume the lead of Quality oversight responsibility and partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state.  Provide quality expertise to support operations, leadership, and clients, enabling the safeguarding and maintenance of patient safety, data integrity and regulatory compliance.

Focus on Data Services and/or PV activities, assigned to projects and/or accounts and collaborates closely with the broader Project Quality & Risk Management P groups and other quality teams.

Key Accountabilities:

Client Liaison

• Effectively communicate with internal and external customers as well as third party vendors, at leadership level
• Prioritize effectively and respond to urgent quality requests within team or from sponsor

Lead, facilitate and support the risk management process for high priority projects/Partnership/account using the available tools

• Lead and facilitate robust project-level risk management, along with others as applicable
• Work with operational teams, functional leads and SMEs to identify, categorize, score and develop mitigations
• Confirm agreed mitigations have been integrated into functional project/partnership/account plans

Lead and facilitate identification, investigation and remediation of high priority quality issues using available tools and methodologies.  Provide oversight, transparency and tracking of quality issues for assigned projects

• Triage quality issues in electronic quality management system (eQMS) ensuring appropriate classification
• Participate in the initial assessment of Serious Breach of GCP
• Assist QI team members in developing containment actions
• Expertly lead QI teams to investigate root causes using various methodologies
• Facilitate development of robust corrective and preventive actions (CAPA)

Analyze key risk indicators and investigate risk signals by performing, reporting, and coordinating risk signal evaluations (RSE), including for high priority projects/partnership/account using dashboards, reports, metrics and other available tools 

• Navigate dashboards to identify risk signals
• Investigate signals by performing associated RSE using available tools
• Communicate areas of risk to project teams through RSE data analysis and other supporting information
• Where assigned to projects or when additional consultancy is required;
• Expertly facilitate identifying the potential root cause
• Assist teams in developing robust mitigation plan
• Assess effectiveness of mitigation plan

Assist with preparations, conduct and response/action plan development for high priority audits/inspections and critical issues

• Support audit/inspection preparation including helping teams set priorities and reviewing key documents
• For non-Clinical Trial contracted activities, support project teams in client driven preparation and ongoing involvement in regulatory inspections or inspection preparedness audits
• Provide onsite or remote support as needed, presenting Parexel Quality and QMS overviews, when necessary
• Expertly lead project team to investigate root causes using various methodologies
• Review all audit/inspection responses prior to final QA review, if necessary
• Expertly lead team to investigate root causes using various methodologies
• Facilitate RCA Meeting & development of robust CAPA

Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter-experts

• Provide real-time quality expertise to enable project teams to deliver first-time quality
• Consult SMEs including other quality experts when necessary
• Independently review and investigate possible project/partnership/account-level SOP deviations as requested Represent Parexel Quality at client and internal meetings

Partner with Operational delivery teams to achieve and maintain inspection-ready state including story board oversight

• Provide guidance on maintaining inspection-ready documentation for high priority projects/Partnership/account.
• Review/update of story boards for high priority projects Partnership/account.
• Encourage project team to use story board to record pre-developed response to a situation not explained through the TMF / file management system
• Review story boards for completeness periodically to for inspection-readiness purposes

Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including fulfilling the role of Portfolio Quality Lead (PFQL)

• Lead quality-to-quality meetings
• As PFQL, perform client-level risk and issue management
• As PFQL, provide client-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership as necessary

Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested

• Identify changes in scope and liaise with Project Leader
• 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.
• Review and provide feedback on quality SOPs as assigned
• Participate in, and provide feedback on any key PQRM initiative, as assigned

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 Parexel 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

Skills:

• Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback
• Strong analytical skills 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 internally and with the client
• Proven skill in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues 
• Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus 
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables
• Ability to travel 10% -15%

Knowledge and Experience:

• 10 - 12 years’ experience in clinical research
• Demonstrated experience in Quality or Risk Management activities
• Expertise in root cause methodologies (e.g. 5-whys, fishbone diagram, etc.) and CAPA development
• Expertise in Clinical Trial Risk Management
• Expertise with ICH-GxP principles and clinical trial or non-clinical trial regulations as applicable
• English proficiency (written and oral)

Education:

• Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred
• Master’s Degree in a science, technology or industry-related discipline preferred