Manager, Project Quality & Risk Management

Baltimore, MD (Hybrid role, Home & Office)

Parexel's Manager will provide leadership and management to our Project Quality & Risk Management staff. You will Innovate and implement quality improvement opportunities at the project, client, operational, department or cross department level.

Collaborate with senior leadership to implement strategy and direction for PQRM staff. 

• Work with direct reports to establish individual contributions to achieving departmental goals. 
• Support PQRM staff in achievement of individual and collective goals 

Contribute to and support PQRM specific risk management utilizing all available tools / dashboards.

• Work with PQRM leaders to identify, categorize, score and develop mitigations 
• Confirm agreed mitigations are being integrated into departmental planning 
• Coordinate and support leaders in regular risk review 
• Assess effectiveness of mitigations with leaders 
• Promote and support documenting lessons learned 

Oversee and support PQRM staff to comply with Parexel standards and regulatory requirements. 

• Verify compliance with Parexel SOPs and other requirements (e.g. applicable curricula) 
• Review, approve (when necessary) and ensure accurate time recording for direct reports (e.g. billing out of department etc.) 
• Provide guidance and ensure compliance with goal setting and PDC requirements 
• Serve as subject matter expert (SME) for Risk Management Process as assigned 

Partner with Quality Assurance to oversee and support audits & inspections, representing Parexel Quality when requested and serving as an escalation point for critical issues.

• Support audit/inspection preparation including coordinating with QA and PQRM regional leadership. 
• Identify and assign resource
• Provide onsite or remote support as needed 
• Represent PQRM in audits and/or inspections 
• Contribute to critical issue resolution by providing expert quality advice and direction 
• Host audits as assigned per role (e.g. EP)​ 

Provide solutions-focused quality consulting. 

• Support direct reports with project-level escalations 

• Review of planned SOP deviations as assigned 
• Escalate issues to PQRM Senior Leadership as necessary 

Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality and Risk Lead or Quality Sponsor. 

• Represent Parexel Quality in client meetings as necessary 
• Serve as the point-of-contact for the client quality representatives as assigned 
• Lead quality-to-quality meetings as needed 
• As Portfolio Quality and Risk, perform client-level risk and issue management 

Attract, recruit, retain and develop PQRM staff. 

• Engage and recruit qualified staff 
• Ensure staff is trained and supported 
• Measure direct reports’ performance against expectations and standards, providing constructive feedback with strengths and areas for improvement, focusing on development of individual employees 

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

• Provide feedback via the appropriate channel when gaps or issues are identified with Parexel processes. 
• Propose ideas to Parexel Quality leadership related to departmental efficiencies, potential improvements, or innovations. 
• Contribute to and participate in the Quality Forums and Quality Review Board (QRB) as requested.

Education:

• Educated to the degree level (biological sciences, pharmacology, health related discipline preferred) or relevant business equivalent.