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Senior Quality Manager, Technology Quality Management
Found in: One Red Cent US C2 - 1 week ago
Parexel Southeast, United States RemoteHome Based, US · As a Sr Quality Manager in Technology Quality Management (TQM) you will manage efforts to define, adopt and oversee compliance to processes and standards as the fundamental baseline for technology solution development, validation and delivery. You will support ef ...
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Manager, Clinical Operations
Found in: One Red Cent US C2 - 1 week ago
Parexel Southeast, United States RemoteJob IntroductionAt Parexel, we are a leading Clinical Research Organization (CRO) company specializing in delivering life-changing medicines to patients. We are seeking a Manager, Clinical Operations to join our team. Our Manager, Clinical Operations works toward building a deepe ...
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Vice President, Technical
Found in: One Red Cent US C2 - 1 week ago
Parexel Southeast, United States RemoteAs one of our ex-FDA colleagues describes it: "you get to see a lot of cool stuff very quickly". · If you're looking for the opportunity to influence the development strategies of pace-setting biopharma companies, there's no better place to be than as a Vice President, Technical ...
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Financial Analyst II/III Corporate FP&A
Found in: Lensa US 4 C2 - 1 week ago
Parexel Southeast, United States RemoteParexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. · Job Title: · Financial Analyst II/III – Corporate FP&A · Job Introduction: · At Parexel, we are a leading Clinical Resea ...
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Integrated Logistics Support
Found in: ZipRecruiter Standard US C2 - 3 days ago
KMS Solutions, LLC Southeast, United StatesJob Description · Job DescriptionIntegrated Logistics Support (ILS) Specialist · Location: Washington, DC (Hybrid) · KMS Solutions, LLC is a technical management/solutions company that specializes in engineering, analysis, and cyber security. Founded in 2005, KMS is a certified ...
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Clinical Operations Leader/Clinical Trials Manager(Sr COL/Sr CTM)- US or Canada
Found in: beBee S2 US - 1 day ago
Parexel Southeast, United States RemoteREMOTE POSITION FOR US AND CANADA**** · As the Clinical Liaison to the Project Leader, the COL leads the clinical aspect of the trial and has a direct impact on the projects, teams, and clients, helping to the benefit of the patients we serve. · The COL has overall accountability ...
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production & logistics manager
Found in: beBee S2 US - 6 days ago
Rush & Company Southeast, United States PermanentThis dynamic apparel company is experiencing tremendous growth and record sales This incredible team is motivated and passionate about their apparel and creating high quality products. Fantastic location and lots of room to grow IN THE OFFICE. Amazing team and culture in place an ...
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marketing director
Found in: beBee S2 US - 3 weeks ago
Rush & Company Southeast, United States PermanentThis incredible consumer goods company makes the highest quality of products that help people in their daily life. They are growing and have an incredible team in place. They believe in sustainability, investing in technology and improving fit and performance as needed. Not a rem ...
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brand development specialist
Found in: beBee S2 US - 4 days ago
Rush & Company Southeast, United States PermanentA fantastic opportunity to join an international company created 50 years ago. This client designs, manufactures and distributes innovative fabrics. Present in 80 countries, they have over 1100 employees, production sites in France, Switzerland Italy, Germany, and Taiwan along wi ...
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Senior Business Analyst
Found in: beBee S2 US - 3 weeks ago
Parexel Southeast, United States RemoteParexel is looking for changemakers who are driven by curiosity, passion, and optimism. Come join us in keeping the Patient at the Heart of Everything We do. · Job Title: · Senior Business Analyst – Clinical, Commercial & Consulting Technologies · Job Introduction: · At Parexel, ...
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Principal CGMP Compliance Consultant
Found in: beBee S2 US - 4 weeks ago
Parexel Southeast, United States RemoteParexel's Strategic CGMP Compliance team is known for our unparalleled breadth and depth of expertise globally. Parexel CGMP Compliance offers services which create and maximize product value for clients throughout the product lifecycle, leveraging our unique fusion of scientific ...
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Full Time Obstetrics and Gynecology Physician
Found in: beBee S2 US - 2 weeks ago
Genesis Healthcare Consultants Southeast, United States Full time1647 - Medical Center in Southeast Mississippi is seeking a Board Certified or Board Eligible OB/GYN. This opportunity is to join a well- established 3-person OB/GYN practice with two office locations. Office hours are 9 to 5 Monday through Friday with each physician working 2 da ...
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Senior Clinical Site Contracts Analyst
Found in: beBee S2 US - 3 weeks ago
Parexel Southeast, United States RemoteJob Summary: · The Senior Clinical Contract Analyst serves as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements (CTAs), Ancillary Services Agreements, Consultant Agreements and other cli ...
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Senior Clinical Contracts Analyst
Found in: beBee S2 US - 4 weeks ago
Parexel Southeast, United States RemoteJob Summary: · The Senior Clinical Contract Analyst serves as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements (CTAs), Ancillary Services Agreements, Consultant Agreements and other cli ...
Associate Director, Project Quality - Southeast, United States - Parexel
Description
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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