Senior R&D Quality Training Associate

3 weeks ago

Cambridge, United Kingdom Gilead Sciences International, Ltd. Full time

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:

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.

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

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.

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 to apply for this job.

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