- Drive and oversee activities or responsibilities related to R&D GxP training and ensure quality and accuracy of deliverables.
- Serves as the primary GxP Training lead for EU and Rest of World (RoW) departmental business processes related to GxP training administration activities, including contributing to cross-functional system / process improvement initiatives.
- Supports internal audits and/or regulatory agency inspections, including retrieval and provision of reports and documentation, as needed.
- Advise customers on applicable policy and standards and partners with functional areas and affiliates to ensure appropriate oversight of the QMS is maintained.
- Supports the assignment of prereleased procedural documents in the Learning Management System (LMS).
- Contributes to and supports the timely completion of projects.
- Monitors, identifies and enables completion of areas of GxP Training areas of improvement.
- Provides GxP training support, including: Accurate entry of data into the validated LMS Quality control of entered data and following appropriate procedures to ensure the quality of information contained in the LMS Evaluation and processing new training and assisting with periodic reviews Monitoring LMS reports to ensure training needs assessments are requested for all newly hired and transferred users Evaluation and processing training needs assessments Guidance and support to R&D groups on R&D Quality Training's best practices, such as creation or modification of training jobs Guidance to business teams related to best practices and the overall principles for quality and consistency of GxP training Providing customer support and training on the use of the LMS and other systems. Development of system reports to meet business needs Assisting with periodic review processing and tracking change requests resulting from reviews Assisting with the creation and revision to R&D Quality Training's procedural documents
- Implements optimizations to support continuous improvement and development of new tools to increase efficiency, such as: Contributing to the implementation, deployment, and ongoing maintenance of innovative tools. Creating metrics and administrative reports, as needed.
- May assist departmental management in directing outsourced service provides and deploying quality control/oversight
- Fosters a commitment to quality in individuals and a culture of quality across Gilead R&D and with R&D vendors.
- Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Demonstrates sound knowledge of quality and compliance requirements as these pertain to medicinal products.
- Demonstrates strong attention-to-detail and good organizational skills.
- Demonstrates strong proficiencies in the Microsoft Office suite.
- Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
- Ability to communicate in a clear and concise manner.
- Ability to support a team-oriented, highly-matrixed environment.
- Ability to execute multiple tasks as assigned.
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Senior R&D Quality Training Associate - Cambridge, United Kingdom - Gilead Sciences
Description
Job Description
For Current Gilead Employees and Contractors:
Please log onto your to apply for this job.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
Job Description
POSITION OVERVIEW:
You will provide R&D quality training support, administration and coordination across the global organization. You will provide oversight to TCS operational staff, including training, onboarding, and management of day-to-day responsibilities. You may also provide support in tracking and reporting on quality training and developing or updating additional departmental tools, such as portals and other tools used to communicate, track and report on R&D quality policies, procedures, other documentation and training.
EXAMPLE RESPONSIBILITIES:
REQUIREMENTS:
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.
Education & Experience
BA/ BS or advanced degree in life sciences, information technology, library science or related field with some relevant work experience, such as quality control, quality assurance, compliance or related areas.
Knowledge & Other Requirements
Equal Employment Opportunity (EEO)
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual's gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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Senior R&D Quality Training Associate professionals in Cambridge
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Vidya Math
Scientific/ Clinical Trials Project Manager