The main focus of the role is to provide leadership and management to Project Quality & Risk Management staff.Identify, innovate and implement quality improvement opportunities at the project-, client-, operational-, department- or cross-department level.

Key Accountabilities

• Collaborate with senior leadership to develop and implement the strategy and direction for the PQRM team in support of Parexel's and Quality's goals/objectives:
• Support defining PQRM's mission and vision to contribute to Parexel's success
• Create and nurture a culture within PQRM to promote open communication, provide opportunities for growth, advocate collaboration and teamwork, reward high performance and being purpose driven
• Propose, lead and implement PQRM initiatives to accomplish PQRM's goals
• Provide direction and collaborate with other PQRM leadership to advance PQRM's direction
• Support PQRM leadership and staff in achievement of individual and collective goals
  Facilitate and lead risk management activities for PQRM:
• Facilitate robust department-level risk management
• Work with PQRM leaders to identify, categorize, score and develop mitigations
• Serve as risk owner or action owner
• 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:
• Create, approve and verify compliance with Parexel SOPs and other requirements (e.g. applicable curricula)
• Review, approve (when necessary) and ensure accurate time recording for regional staff (e.g. billing out of department etc.)
• Provide guidance and ensure compliance with goal setting and PDC requirements
• Serve as a Subject Matter Expert for varied PQRM activities
• 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 to ensure appropriate Quality resource availability
• Provide onsite or remote support as needed
• Contribute to critical issue resolution by providing department-level expert quality advice and direction
• Represent PQRM in audits and/or inspections
• Provide solutions-focused quality consulting, facilitating quality delivery
  using available analytics and other tools:
• Partner with operational leadership to promote first-time quality deliverables, applying solutions-focused consultancy.
• Review, analyze and provide guidance related to operational quality metrics as necessary or assigned
• Build and maintain relationships with client quality representatives. Fill role of CQRL and/or Quality Sponsor:
• Represent Parexel Quality in client meetings as necessary
• Serve as a resource for client escalations, including collaborating with Parexel operational leadership to repair or mend client relationships
• Serve as the point-of-contact for the client quality representatives.
• Lead quality-to-quality meetings as needed
• As CQRL, perform client-level risk and issue management
• As CQRL, provide client-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership as necessary
• As CQRL, develop/revise quality agreement
• As Quality Sponsor, serve as senior-level point-of-escalation, communicating with senior client quality partners
• 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.
• Lead PQRM performance-improvement initiatives
• Attract, recruit, retain and develop PQRM staff:
• Engage and recruit qualified staff
• Ensure trained, knowledgeable staff are sufficient to meet organizational needs, develop business case if insufficient
• Build employee pipeline, ensuring career growth opportunities and adequate succession planning
• Measure direct reports' performance against expectations and standards, providing constructive feedback with strengths and areas for improvement, focusing on development of individual employees

Skills and expertise

• Excellent communication skills, including executive-level verbal and written communication, active listening, providing constructive feedback and facilitating group discussions.
• Expert ability to think globally, strategically and analytically to problem-solve, make decisions keeping the patient and customer in focus.
• Excellent interpersonal skills, able to develop relationships and partnerships, build rapport, persuade and influence teams, motivate others, manage performance and develop talent.
• Strong change leader, able to understand and implement change while anticipating and managing resistance.
• Expert project manager with strong organizational and planning skills, competency in risk management with thoughtful action planning.
• Personal awareness and emotionally intelligent, ability to self-motivate, innovate, delegate, and manage time as well as taking ownership and accountability for deliverables.
• Ability to travel 30%-50%

Knowledge and Experience

• 10+ years' experience in data quality management
• 7-10 years' experience managing people
• Expertise in ICH-GxPs
• English proficiency (verbal and written)

Education

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