Home Based, US
Provide leadership and management to other Project Quality & Risk Management 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
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
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 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
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.
Lead quality-to-quality meetings as needed
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.
Serve as senior-level point-of-escalation, communicating with senior client quality partners
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
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
Maintain compliance with Parexel standards.
Comply with required training curricula
Accurately complete timesheet as required
Submit expense reports as required by SOP
Update CVs as required by SOP
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-GxP's
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.
LI-REMOTE
Associate Director/Director, Process Engineering and Validation
Establish criteria to ensure processes are scalable and robust for drug substance manufacture (including the related raw materials and intermediates) and the routes and strategies are suitable for commercialization. Establish, review, and support process validation DOE strategies and evaluations to ...
Associate Director, Program Management, Infectious Disease
Moderna is seeking a motivated and energetic Associate Director, Program Management to drive the program teams forward in the development of novel mRNA medicines within the Infectious Disease Portfolio. Collaborate with functional leads to define program strategy and proactively identify and escalat...
ASSOCIATE DIRECTOR, STUDENT SERVICES & OPERATIONS, Metropolitan College, Enrollment & Student Success
The Associate Director for Student Services & Operations will lead the effort to optimize our student data integrity by increasing the frequency and methods of tracking, clean-up, and student support. Regular oversight of student record updates and the associated impacts will lead to an overall ...
Associate Product Manager Studies and Sample Management
Serve as the primary communicator and liaison between the scientific SMEs consuming our products and the Digital team generating them, ensuring clear understanding and collaboration across the organization. First-hand experience in Product Management operating principles and tools (JIRA, Persona Def...
Transportation and Emergency Management Project Manager
Responsible for proactively managing the projects technical budget (direct labor and expenses, including technical sub-consultants), schedule, technical requirements, contractual obligations, project communications and HNTB’s 4 for 4 (Consistent delivery of quality work, on time, on budget, and to t...
Project Manager
Actively manages client budgets, schedules, and programs; budget and schedule; project communications and documentation; office administrative tasks; and project team assignments. The Sr Project Manager is responsible for the day to day management and delivery of assigned projects with specific focu...
Sr. Manager / Associate Director Quality Assurance
We are seeking an experienced QA professional to support and evolve the quality management systems and processes at our US Site located in Burlington, MA. Director of Global GCP/GLP compliance and while working closely with the US Site VP and the Global Quality team. They will play a key role in exp...
Strategic Sourcing Associate Director, Cell & Gene Therapy CDMO (hybrid)
This role requires a deep understanding of the cell and gene therapy landscape, including market dynamics, regulatory requirements, and emerging trends, In addition to understanding of technology, functionality, specifications, CDMO landscapes, and industry regulations to ensure robust partnership, ...
Associate Director, Program Management
...
Director and Associate Dean for Research
The UMass Chan-Lahey Regional Campus Medical School seeks an innovative and strategic individual to serve as the inaugural Director of the Lahey Institute for Healthcare Delivery Science and Associate Dean for Research. After a joint strategic planning process, Lahey and UMass Chan executed a follow...