Quality System and Processes Lead

Under the supervision of a Quality System and Processes Manager or Senior Quality System and Processes Manager, the Quality System and Processes Lead assists in overseeing development, implementation, and continual improvement of quality systems, programs, and processes. This position assists in the management of implementation of the policies and objectives for quality and the underlying organizational processes, ensuring compliance to various standards, improvement of processes, development, and monitoring of appropriate key performance indicators. The position may also provide guidance and, training to less senior department members. Additionally, the Quality System and Processes Lead supports and may host internal and external audits, and assists in review, resolution, and closure of corrective actions and client feedback.

About Regulated Industries

RWS Regulated Industries is a highly specialized division of RWS, a world-leading provider of technology-enabled language, content, and intellectual property services. The Regulated Industries division is focused on developing translation and content management solutions tailored to address the complex regulatory environment in force with premium sectors such as Life Sciences and Healthcare (pharmaceuticals, medical devices, CROs, healthcare companies), Finance (banks, asset management companies, insurance providers, fintech) and Legal (law firms, audit companies).

Key Responsibilities

Assist with defining gaps in internal systems to support development of documented improvement projects to address them.
• Administer global ISO Quality Management System documents, maintenance, revisions, and version control.
• Work with department managers and personnel to ensure all Quality Management documents are up-to-date and reviewed periodically.
• Manage and complete incoming quality questionnaires for various customer compliance departments.
• Assist in monitoring client feedback and customer satisfaction survey results to identify areas for continual improvement.
• Administer the Corrective and Preventive Action system, providing input, oversight and approval to investigation and root cause analysis, identification, and approval of CAPA Plans, confirmation of CAPA implementation and Effectiveness through review of objective evidence.
• Monitor and assist in facilitating open Corrective Action Plans for timely completion.
• Assist with Management Review preparation.
• Contribute to the reporting of customer and internal KPIs.
• Participate and assist in the review, root cause, and resolution of customer feedback.
• Support audits conducted by both internal and external parties, and facilitate and conduct internal audits.
• Perform Quality Investigations related to audit findings and provide follow up to external parties related to external audit findings and actions.
• Maintain up-to-date knowledge of industry trends in regulated industry translation, regulatory changes that may impact delivery of translation services, as well as the competitive landscape within the localization for regulated industries space.
• Actively participates in management and other meetings. Develops reporting procedures for timely and accurate reporting requirements.
• May recommend and assist in writing policies, procedures and/or actions for the purpose of improving efficiency and product quality and providing direction for meeting the company's quality objectives.
• Assist in developing and support department/team goals and objectives.

Skills & Experience

• Demonstrated successful quality systems or related administration experience minimum three years.
• Experience in other industries, particularly in the regulated space such as pharma or medical devices is also welcome
• Bachelor's Degree or equivalent work experience in Business, English, Foreign Language, Linguistics, Social or Applied Science, or other related field.
• Translation, Localization Project Management, Localization Operations Management, or Localization Quality systems experience is preferred but not exclusive
• Knowledge of English grammar, syntax, and word usage and excellent writing skills
• In-depth understanding of company-wide project planning, project management, and technical services procedures. Knowledge of all other Company processes.
• Exceptional organizational and time management skills; ability to prioritize
• Ability to communicate effectively, both orally and in writing.
• Ability to make formal presentations to clients and industry colleagues on all service-related topics.
• Ability to provide guidance for employees and provide clear direction in a respectful manner.
• Ability to communicate with, train, and support employees through changes.
• Ability to make decisions and support employees through problems on job-related issues.
• Ability to carry out instructions furnished in written or oral form, and to work without supervision.
• Ability to understand, apply and use personal computers and software applications (e.g., Word, Excel, PowerPoint, Outlook, Adobe Acrobat, Teams).
• Ability to analyze and problem solve job-related issues.
• Ability to work with a diverse group of individuals across different levels of the company.
• Ability to maintain confidentiality of information regarding company financial and other information.
• Ability to establish and maintain cooperative working relationships with others contacted in the course of work.
• Teamwork and consensus-building skills.
• Ability to resolve customer service issues in a professional and efficient manner.

At RWS, we're here for one purpose: unlocking global understanding.

As a unique, world-leading provider of technology-enabled language, content, and intellectual property services, we remove the barriers to communication to make global connection possible. Our unrivalled experience and deep understanding of language have been developed over more than 60 years. As we look to shape the future, our ambition is to create a world where understanding is universal for everyone.

We work with over 80% of the world's top 100 brands, more than three-quarters of Fortune's 20 'Most Admired Companies' and almost all the top pharmaceutical companies, investment banks, law firms and patent filers. Our client base spans Europe, Asia Pacific and North and South America. Our 65+ global locations across five continents service clients in the automotive, chemical, financial, legal, medical, pharmaceutical, technology and telecommunications sectors.

Over the past 20 years we've been evolving our own AI solutions as well as helping clients to explore, build and use multilingual AI applications. With 45+ AI-related patents and more than 100 peer-reviewed papers, we have the experience and expertise to support clients on their AI journey.

If you like the idea of working with smart people who are passionate about breaking down language barriers and giving back to their communities, then you'll love life at RWS. Our work fundamentally recognizes the value of every language and culture. So, we celebrate difference, we are inclusive and believe that diversity makes us strong.

We want every employee to grow as an individual and excel in their career. In return, we expect all our people to live by the values that unite us: to partner with colleagues and clients, to adopt a pioneering spirit, to be positive in progressing the work we do, and always to deliver what we promise.

RWS Values

Get the 3Ps right - Partner, Pioneer, Progress - and well Deliver together as One RWS.

For further information, please visit: RWS

RWS embraces DEI and promotes equal opportunity, we are an Equal Opportunity Employer and prohibit discrimination and harassment of any kind. RWS is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at RWS are based on business needs, job requirements and individual qualifications, without regard to race, religion, nationality, ethnicity, sex, age, disability, or sexual orientation. RWS will not tolerate discrimination based on any of these characteristics

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