Senior Validation and Compliance Manager

6 days ago

Bengaluru, Karnataka, India Allucent Full time
Senior Validation and Compliance Lead

We are seeking a seasoned professional to lead our validation and compliance efforts in Technology & Innovation assigned projects at Allucent. The ideal candidate will possess a deep understanding of GxP, GAMP 5, 21CFR11, EudraLex V4 Annex 11, and other relevant regulations.

Key Responsibilities:

  • Develop and implement a CSV strategy.
  • Support the lifecycle of computerized system validation activities.
  • Participate in risk assessments to identify and mitigate compliance risks.
  • Work with IT, QA, and functional teams to integrate validated systems into daily operations.
  • Help maintain CSV documentation and assist in staff training.
  • Stay informed about technological advancements and regulatory changes.
  • Assist in audits related to computerized systems and support corrective actions.
  • Contribute to continuous improvement by recommending process enhancements.
  • Help assess IT controls and processes for alignment with policies and procedures.
  • Support the development of the Risk Management Framework and Data Governance standards and processes.
  • Guide teams to leverage data integrity controls to ensure data accuracy, security, consistency, and reliability.
  • Actively contribute to staff learning & development within the Company.
  • Provide and coordinate Validation Testers training for relevant staff.
  • Review, improve, and evaluate processes and procedures within the Quality Management System.
  • Ensure that all processes and systems meet quality standards and regulatory requirements.
  • Support audit and inspection readiness by maintaining accurate and complete validation and compliance documentation.
  • Actively participate in the resolution of audit/inspection findings and associated CAPAs.
  • Assure strong, long-lasting relationships with key accounts.
  • Support in the preparation of new proposals.
  • Contribute and take part in client evaluations, visits, and bid defences.

Requirements:

  • Degree in Computer Science, Information Technology, Life sciences, or a related field.
  • Minimum of 5 years of experience in computerized system validation within a CRO, pharmaceutical, or biotechnology environment.
  • Thorough knowledge of GxP, GAMP 5, 21CFR11, EudraLex V4 Annex 11, and other applicable regulations.
  • Strong analytical and process-oriented skills.
  • Proficiency in Computer System Validation and managing testing teams for user acceptance testing.
  • Strong written and verbal communication skills, including a good command of the English language.
  • Representative, outgoing, and client-focused.
  • Ability to work in a fast-paced, challenging environment of a growing company.
  • Administrative excellence.
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint.
  • Strong leadership skills.
  • Effective at problem-solving, strategic thinking, and conflict resolution.
  • Strong presentation and networking capabilities.
  • Excellent organizational, negotiating, and financial skills.

Benefits:

  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • Leadership and mentoring opportunities.
  • Participation in our enriching Buddy Program as a new or existing employee.
  • Internal growth opportunities and career progression.
  • Financially rewarding internal employee referral program.
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms.
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects.
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees.

  • Senior IT Validation

    4 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Senior IT Validation & Compliance SpecialistAs a Senior IT Validation & Compliance Specialist at Novo Nordisk, you will play a critical role in ensuring the quality and integrity of our IT systems and processes. Your responsibilities will include:Developing and implementing validation strategies for IT systems and processesPerforming risk assessments and...

  • Senior Validation and Compliance Lead

    1 week ago

    Bengaluru, Karnataka, India Allucent Full time

    Job Title: Senior Validation and Compliance LeadAbout the Role:We are seeking a highly skilled Senior Validation and Compliance Lead to join our team at Allucent. As a Senior Validation and Compliance Lead, you will be responsible for leading the validation and compliance activities within Technology & Innovation assigned projects. This includes controlling...

  • Senior Validation and Compliance Lead

    2 weeks ago

    Bengaluru, Karnataka, India Allucent Full time

    Job Title: Senior Validation and Compliance LeadAbout the Role:We are seeking a highly skilled Senior Validation and Compliance Lead to join our team at Allucent. As a Senior Validation and Compliance Lead, you will be responsible for leading the Validation and Compliance activities within Technology & Innovation assigned projects at Allucent.Key...

  • Senior Validation and Compliance Lead

    2 weeks ago

    Bengaluru, Karnataka, India Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials and bring life-changing therapies to patients worldwide.We are seeking a Senior Validation and Compliance Lead to join our team. As a Senior Validation and Compliance Lead, you will be responsible for leading validation and...

  • Senior IT Validation

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleAs a Senior IT Validation & Compliance Specialist at Novo Nordisk, you will play a key role in ensuring the quality and integrity of our IT systems. Your responsibilities will include executing the validation strategy, performing assessments, and providing compliance consulting for IT projects.Key ResponsibilitiesAct as a Subject Matter Expert...

  • Senior IT Validation

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleAs a Senior IT Validation & Compliance Expert at Novo Nordisk, you will be responsible for executing the validation strategy in Agile and V Model environments. Your key responsibilities will include performing IT Risk Assessments, Quality and functional assessments, and providing compliance consulting for IT projects.Key QualificationsMCA,...

  • Senior IT Validation

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Roles and Responsibilities:As a Senior IT Validation & Compliance Expert at Novo Nordisk, you will serve as a Subject Matter Expert (SME) for Validation activities, executing the validation strategy both in Agile and V Model as necessary.You will perform various assessments, including IT Risk Assessment (ITRA), IT Requirements Risk Assessment (ITRRA),...

  • Senior IT Validation

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Senior IT Validation & Compliance Specialist to join our Digital Quality Transformation team at Novo Nordisk. As a key member of our team, you will be responsible for ensuring the quality and reliability of our IT systems, while also driving digitalization and quality improvements across our organization.Key...

  • Senior IT Validation and Compliance Expert

    4 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleAs a Senior IT Validation and Compliance Specialist at Novo Nordisk, you will play a crucial role in ensuring the quality and integrity of our IT systems. Your responsibilities will include:Key ResponsibilitiesActing as a Subject Matter Expert (SME) for Validation activities and executing the validation strategy in Agile and V Model...

  • IT Validation and Compliance Specialist

    4 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Job Title: IT Validation and Compliance Specialist IAbout the Role:As an IT Validation and Compliance Specialist I at Novo Nordisk, you will play a crucial role in ensuring the quality and compliance of our computerized systems and equipment. Your responsibilities will include performing activities related to Computer System Validation (CSV) and Computer...

  • Senior IT Validation

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Senior IT Validation & Compliance Specialist to join our Digital Quality Transformation team at Novo Nordisk. As a key member of our team, you will be responsible for ensuring the quality and reliability of our IT solutions.Key ResponsibilitiesAct as an SME for Validation activities and execute the validation...

  • IT Validation and Compliance Specialist

    4 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Job Title: IT Validation and Compliance Specialist IAs an IT Validation and Compliance Specialist I at Novo Nordisk, you will be responsible for ensuring the quality and compliance of our IT systems and processes.Key Responsibilities:Perform Computer System Validation (CSV) and Computer Software Assurance (CSA) activities in line with Novo Nordisk's Quality...

  • Senior IT Validation

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking a highly skilled Senior IT Validation & Compliance Specialist to join our Digital Quality Transformation team at Novo Nordisk. As a key member of our team, you will be responsible for ensuring the quality and reliability of our IT systems, while also driving digitalization and quality improvements across our organization.Key...

  • Senior IT Compliance Manager

    6 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleAs a Senior IT Compliance Manager at Novo Nordisk, you will oversee the implementation of effective validation strategies to ensure adherence to regulatory requirements. Your expertise in IT quality assurance and compliance will be instrumental in driving quality across the organization.ResponsibilitiesDevelop and execute validation strategies...

  • IT Validation and Compliance Specialist

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the RoleWe are seeking an IT Validation and Compliance Specialist to join our Site Collaboration Solutions team at Novo Nordisk. As an IT Validation and Compliance Specialist, you will be responsible for performing activities related to Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management...

  • Senior Validation and Compliance Lead

    2 weeks ago

    Bengaluru, Karnataka, India Allucent Full time

    Job OverviewAt Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials and bring life-changing therapies to patients in need worldwide. We are seeking a Senior Validation and Compliance Lead to join our team and play a critical role in ensuring the quality and integrity of our...

  • Senior Validation Engineer

    4 weeks ago

    Bengaluru, Karnataka, India TE Connectivity Full time

    {"title": "Global Senior Computer Systems Validation Engineer", "company": "TE Connectivity", "overview": "At TE Connectivity, we believe EVERY CONNECTION COUNTS. We are a $12 billion global technology leader providing essential connectivity and sensor solutions in today's increasingly connected world.", "responsibilities": ["Identify and deliver software...

  • Senior Validation Engineer

    4 weeks ago

    Bengaluru, Karnataka, India TE Connectivity Full time

    Job Title: Global Senior Computer Systems Validation EngineerAt TE Connectivity, we're committed to delivering innovative solutions that transform industries. As a Global Senior Computer Systems Validation Engineer, you'll play a critical role in ensuring the quality and compliance of our enterprise systems.Key Responsibilities:Develop and implement software...

  • IT Validation and Compliance Specialist I

    2 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Job SummaryAs an IT Validation and Compliance Specialist I at Novo Nordisk, you will be responsible for performing activities related to Computer System Validation (CSV) and Computer Software Assurance (CSA) in line with the company's Quality Management System (QMS). This includes validation for GxP Computerized Systems and Computerized Equipment in both...

  • IT Validation and Compliance Specialist I

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Job SummaryAs an IT Validation and Compliance Specialist I at Novo Nordisk, you will be responsible for performing activities related to Computer System Validation (CSV)/ Computer Software Assurance (CSA) in line with Novo Nordisk Quality Management System (QMS). This includes validation for GxP Computerized Systems/ Computerized Equipment both in project...