Associate Director, Project Quality

2 weeks ago

Billerica, United States Parexel International Corporation Full time

Home Based, US

As Associate Director, Project Quality & Risk Management you will provide leadership and management to other Project Quality & Risk Management (PQRM) staff. Innovate and implement quality improvement opportunities at the project, client, operational, department or cross-department level.

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 senior leadership to translate mission and vision to define PQRM's contribution to Parexel's success
* Enable line managers to define contributions to support PQRMs mission and vision
* Propose, lead and implement PQRM initiatives to accomplish PQRM's goals
* Collaborate with other PQRM leadership to advance PQRM's direction

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
* Integrate mitigations into departmental planning
* Support leaders in regular risk review
* Assess effectiveness of mitigations with leaders

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 regional staff (e.g. billing out of department etc.)
* Provide guidance and ensure compliance with goal setting and PDC requirements
* Serve as SME 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
* Contribute to critical issue resolution by providing 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, when required.

* Represent Parexel Quality in client meetings
* 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.
* Perform client-level risk and issue management
* Provide client-level quality oversight serving as a point of escalation, communicating pertinent information to account leadership
* Develop/revise quality agreement.

Attract, recruit, retain and develop PQRM 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

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

Mentor PQRM Leaders as needed.

* Serve as an integration partner to facilitate induction to PQRM leadership.
* Establish formal, documented plan for each new hire assigned.

Skills:
* Excellent communication skills, including verbal and written communication, active listening, providing constructive feedback and facilitating group discussions.
* Developing ability to think globally, strategically and analytically to problem-solve, make decisions keeping the patient and customer in focus.
* Strong interpersonal skills, able to develop relationships and partnerships, build rapport, persuade and influence teams, motivate others, manage performance and develop talent.
* Developing 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.
* Ability to travel 10%-15%

Knowledge and Experience:
* 12-15 years' experience in late phase clinical research
* 5-7 years' experience managing people
* Expertise in ICH-GxPs
* 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.


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