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Parexel International Corporation

Senior Director, Data Services Quality Management

Parexel International Corporation, King of Prussia, PA, United States


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

Required

    Preferred

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