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
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