Senior Quality Manager, Technology Quality Management

3 weeks ago

Southeast Fairbanks, United States Parexel Full time

Home 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 efforts, in collaboration with the business to monitor, identify and implement continuous process improvement across all technology business units.
In addition, you will support validation efforts and provide expertise to ensure technology projects adhere to established standards and quality expectations. Manage activities to develop and perform assessments on technology projects to identify and mitigate risks and prevent quality concerns. Manage monitoring and maintenance of oversight for the selection and implementation of technology solutions for quality management in support of delivery of products and services to customers. Manage the vision and direction for the development and implementation of Parexel's business intelligence infrastructure.

Key Accountabilities:

Quality Representative

Custodian and leader of the Parexel Quality System. Acts and is recognized as an ambassador for quality across the business and with customers.Leads development, implementation and management of Parexel strategic objectives.Contact for management and peers across the business to establish and maintain a communication framework that removes constraints and ensures timely and effective action related to matters of quality. Representation and leadership at quality related meetings that govern, maintain and improve the Parexel Quality System.Attend and support internal and client meetings to collaborate with and participate in discussions related to quality. Performs general and administrative tasks including accurate and timely completion of TIME and travel expense reports.Standards & Quality FrameworkLeads together with functional leads to design, re-engineer, implement and adopt the quality framework for the validation and release of interfaces and solutions.Alongside the business and team leads, leads activities to identify highest risk/value improvements for process architecture, subject to quality oversight, including Standard Operating Procedures, Manuals and other adjunct documentation in support of the quality system.Leads in the development, implementation and continuous improvement of the training and adoption program focused on infrastructure, and related change control and problem management processes. Collaborates with stakeholders to increase efficiency, leverage influence and maximize process adoptionTechnology Solution Project Quality OversightProvide guidance, consultation and overall expertise to project teams in support of clinical trial and/or validation activities through the applicable lifecycle.Supports others in overseeing, monitoring compliance status and activities to ensure compliant state for a project, business area or portfolio.Leads activities to identify requirements for key validation deliverables, including but not limited to validation planning, resource estimates, risk and impact assessments, summary reporting and Electronic Records/Electronic Signature regulations (where applicable).Leads and supports colleagues to guide risk mitigation to identify, categorize and define associated risks and their mitigation plan to ensure risks are removed.For technology-related Quality Issues (QIs), provide support to internal customers with QI management, with particular emphasis on appropriate description of the issue, accurate classification, oversight of root cause analysis and consultation on appropriateness of corrective and preventive actions.Leads Change Control Board (CCB) team members, responsible for authorizing or rejecting change requests from a technology quality and validation perspective.Commercial ServicesSupports audit/inspection hosts with planning, coordination and hosting of technology related Sponsor audits.Provide standard presentation for covering Technology Solution Life Cycle and general IT area in audit/inspection.Supports audit/inspection hosts in collation and finalization of audit responses.Provide guidance to team leads in providing quality and GxP regulatory advice for technologies including risk assessment(s)/ used in a trial or trial program (client account) clarifying customer quality expectations for technologies including for system design/delivery and its maintenance.Leads activities for development of risk management processes in line with industry best practices and standards.SkillsExpert in computer technology quality and compliance (including computerized system validation) and the pharmaceutical industry across multiple disciplines within Clinical Drug Development (Phase I/II/III/IV) and/or Manufacturing.Advanced knowledge of continuous improvement methodologies.High ability to work in a customer-focused, fast-paced and rapidly changing environment with the high ability to prioritize workload and manage multiple and varied tasks with enthusiasm and supervision.Exhibits a sense of urgency when addressing problems and ensures completion of commitment.Culturally aware and ability to think and work globally.Knowledge & ExperienceExpert in functionally managing teams to meet project goals.Clinical trials and /or research work experience required, with emphasis on GCP and technology compliance.Expert in technology as it relates to clinical trial activities, including System Life Cycle process and applicable GCP regulations pertaining to Computer Systems.Expert of project management, Lean Six-Sigma, auditing and/or risk management methodologies.EducationEducated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification, or 7+ years clinical research experience.Postgraduate degree in a science, technology or industry-related discipline preferred.Industry recognized qualification i.e. project management, Lean Six-Sigma, auditing and/or risk management.
#LI-REMOTE

  • Senior Project Quality

    5 days ago

    Southeast Fairbanks, United States Parexel Full time

    Home Based, USAs a Sr Project Quality & Risk Lead you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients.Responsibilities:Analyze key risk indicators and investigate risk signals by...

  • Senior Travel and Expense Manager

    2 weeks ago

    Southeast Fairbanks, United States Parexel Full time

    The Senior Manager, Travel and Expense (T&E) for the Americas region is a pivotal role designed to provide strategic leadership and operational oversight across all travel and expense activities within the corporate business travel sector. This individual will be responsible for ensuring the seamless execution of T&E operations, delivering exceptional...

  • outbound manager

    4 weeks ago

    Southeast Fairbanks, United States Rush & Company Full time

    This 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 and excellent benefitsWe are looking for an Outbound Manager to join an incredible...

  • production & logistics manager

    3 weeks ago

    Southeast Fairbanks, United States Rush & Company Full time

    This 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 and excellent benefitsWe are looking for a Production & Logistics Manager with 8+...

  • customer experience manager

    7 days ago

    Southeast Fairbanks, United States Rush & Company Full time

    This 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 growIN THE OFFICE five days a week. Incredible team and culture in place. Excellent benefitsWe are looking for a Customer Experience...

  • Executive Director Portfolio Management

    2 days ago

    Southeast Fairbanks, United States Parexel Full time

    Executive Director of Portfolio Management supports the OED Enterprise Portfolio Management team to vet, plan, execute and report progress on the corporate initiative portfolio. This role will play a key role in the unified PMO construct and internal investment governance model enabling operational excellence. The Exec DIR Portfolio Management proactively...

  • marketing director

    1 month ago

    Southeast Fairbanks, United States Rush & Company Full time

    This 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 remote or hybrid opportunity.We are looking for a Marketing Director with 6+ years...

  • Clinical Operations Leader/Clinical Trials Manager(Sr COL/Sr CTM)- US or Canada

    1 month ago

    Southeast Fairbanks, United States Parexel Full time

    REMOTE 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 for the execution of the clinical operations strategy on the Project. They are...

  • General Manager

    24 hours ago

    Fairbanks, United States Simard Automotive Full time

    Job DescriptionJob DescriptionSimard Automotive is looking for a full-time, enthusiastic, results-driven and forward-thinking General Manager to join our amazing culture. As a General Manager, you are a part of a dynamic team that allows you to grow as Simard Automotive grows.Who You AreYou have a passion for providing world-class service to customers,...

  • Catering and Events Manager

    17 hours ago

    Fairbanks, Alaska, United States Raven Landing Senior Community Raven Landing Center Full time

    Raven Landing Center and Raven Landing Senior Community seek a dynamic, motivated leader to oversee our Catering and Events. If you know the restaurant and/or catering industry, and have leadership experience, we invite you to apply.The Catering and Events Manager leads a key area of our operations:Promoting RL event space and catering;Liaising with the...

  • Civil Project Engineer/Manager

    4 weeks ago

    Fairbanks, United States Respec Full time

    Company DescriptionJob Description Worldwide, people choose us-and stay with us. Clients trust RESPEC to propel their projects forward with an innovative, clear vision because they know we see things from a different perspective. Our 100% employee-owned company offers solutions for any challenge and every idea. What others may deem impossible we find to be...

  • Performance Center Manager

    4 weeks ago

    Fairbanks, United States Strategic Resources Inc Full time

    Performance Center Manager (Various Locations, See TE 3B Places of Performance) Strategic Resources, Inc. (SRI) is an international, ISO 9001:2015 Certified, CMMI Level 3 Rated full-service provider with more than 35 years’ experience in the Federal, Military, and Commercial Marketplaces. SRI is seeking committed and passionate professionals to provide...

  • Enterprise Account Executive

    2 days ago

    Southeast Fairbanks, United States Granicus LLC Full time

    The Granicus Local Enterprise Sales Team is a dynamic, results-driven group charged with driving new revenue in a young and energized Cloud Vertical.Ours is a Team that values individual initiative as well as teamwork. What we do makes a difference. Our products and services improve the efficiency of government and the quality of people's lives.The...

  • ITIL Service Now Incident Manager

    3 hours ago

    Fairbanks, United States Intellifusion Company Inc Full time

    Home / DevOps / ITIL Service Now Incident Manager · Act as the Single Point of Contact for managing incidents and outages · Collaborate with the Customers Service Management team if any during Incident Management process definition and documentation · Liaise with the Business and IT stakeholders both internal and external during Major Incident P1P2...

  • Housing Manager

    4 weeks ago

    Fairbanks, United States Army Installation Management Command Full time

    Summary Please limit your resume to 5 pages. If more than 5 pages are submitted, only the first 5 pages will be reviewed to determine your eligibility/qualifications. About the Position: You will serve as a Housing Manager with responsibility for the planning, management, administration, coordination and implementation of the installations housing...

  • art director

    1 month ago

    Southeast Fairbanks, United States Rush & Company Full time

    This 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 and excellent benefitsWe are looking for an Art Director with 8+ years of...

  • controller

    7 days ago

    Southeast Fairbanks, United States Rush & Company Full time

    This 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 and excellent benefitsWe are looking for a Controller with 5+ years of experience...

  • Behavioral Health Data Entry and Quality Assurance Specialist

    4 weeks ago

    Fairbanks, United States Restore Incorporated Full time

    Job DescriptionJob DescriptionSalary: $14.00 - $20.00 per hour Organization Description: Restore Incorporated is a nonprofit faith-based agency with over 10 years of experience providing community-based support services for people with substance use disorders and behavioral health. We provide residential inpatient treatment for ASAM level 3.3 and 3.1...

  • Full Time Obstetrics and Gynecology Physician

    1 month ago

    Southeast Fairbanks, United States Genesis Healthcare Consultants Full time

    1647 - 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 days per week in each office (1 day off each week). This opportunity will include...

  • Principal CGMP Compliance Consultant

    2 weeks ago

    Southeast Fairbanks, United States Parexel Full time

    Parexel'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, regulatory, and business expertise. We are the pre-eminent regulatory and GxP...