Staff IT Security,Risk&Compliance analyst

Job title: Staff IT Security,Risk&Compliance analyst

Company: Leading-Biotechnology-Company


Job description: About Leading-Biotechnology-CompanyANSR, a market leader in enabling organizations to build, manage and scale global teams, is partnering with a renowned biotechnology company who is redefining the future of human health by providing solutions to some of the most complex problems in the healthcare industry. They are committed to making precision medicine accessible and carries out their business operations in an environmentally sustainable way.Now is your opportunity to join their innovative team in Bengaluru, India. For over 20 years now, companies cutting across size, industry and markets have relied on ANSR’s expertise to successfully build global business and technology teams. We can help you land a rewarding career in this dynamic industry.If you are eager to contribute to a company with strong values, a supportive environment and where you get opportunities to work on challenging projects that uses cutting-edge technology to improve millions of lives, this is your chance to join a truly remarkable team. Apply today!Job DescriptionAbout Illumina:Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems dedicated to making genomics useful for all. Illuminas integrated Indian global hub in Bengaluru, Illumina India Biotechnology Private Limited, is focused on technology activities that will help usher in the next wave of innovation in healthcare and medical research. If youre eager to work on challenging projects that uses cutting-edge technology to transform the future of healthcare, this is your chance to join a truly remarkable team.Job DescriptionResponsibilities:

• Advise project teams and internal GIS customers on validation scope, risk, and validation approach.
• Maintain and manage the status of validated applications.
• Conduct audit readiness checks.
• Participate in project and system requirements gathering/authoring and coordinate activities with business users and analysts.
• Coordinate the Change Management process within the GIS organization.
• Review system changes and provide compliance assessments and audit-ready closure summaries.
• Investigate root causes of defects and failures; author and/or investigate non-conformances and CAPAs.
• Provide direction, support, and motivation to team members to achieve organizational goals.
• Track key performance indicators, analyze data, and report on team progress to senior management.
• Manage projects and operations, ensuring effective use of resources.
• Address and resolve conflicts within the team and across functional groups, fostering a positive and productive work environment.

Listed responsibilities are essential but not exhaustive. Responsibilities may evolve based on business needs.Requirements:

• 8+ years of experience in the life sciences industry focusing on computer systems validation.
• Strong oral and written communication skills to influence and advise stakeholders on regulatory compliance processes.
• Strong organizational skills for managing multiple validation projects.
• Experience working with cross-functional teams and aligning on validation strategies.
• Experience with enterprise applications such as SAP, LMS, Salesforce, ETQ, etc.
• Proficiency with test management tools such as HP Quality Center, ValGenesis, and TFS.
• Ability to articulate risk-based validation strategies tailored to business needs.
• Excellent customer service and interpersonal skills.
• Familiarity with regulations and frameworks such as 21 CFR Part 820/11, ISO 13485, and GAMP.
• Understanding of software development lifecycle activities, testing, and validation.
• Experience managing workload using IT service management ticketing tools, preferably ServiceNow.
• Knowledge of common IT infrastructure and applications, such as virtualization, directory services, storage, and DBMS.

People Leadership:

• Communicate clearly and effectively to keep the team informed and engaged.
• Identify and resolve problems, implementing solutions to improve efficiency and productivity.
• Define team objectives, develop strategies, and implement action plans to achieve goals.
• Delegate tasks and responsibilities effectively, ensuring alignment with overall goals.
• Enforce company policies and procedures, ensuring employee compliance with regulations.

Experience / Education:

• Typically requires a minimum of 8 years of experience in the life sciences industry with a bachelors degree, or 5 years with a masters degree.
• Minimum of 3 years of experience in people management.

All listed requirements are considered essential functions of this position. However, reasonable accommodations may be made in response to changing business needs.

Expected salary:

Location: Bangalore, Karnataka

Job date: Sun, 25 May 2025 07:22:43 GMT

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