Sr. Validation and Compliance Lead

3 days ago

Bracknell, United Kingdom Allucent Full time

At 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 (India) to join our A-team (hybrid*). As a Senior Validation and Compliance Lead will be responsible for leading the Validation and Compliance activities within Technology & Innovation assigned projects at Allucent. This position controls and monitors the Validation and Compliance status of GxP impacting systems, ensures planning, preparation, and execution of validation and testing activities in accordance with standard operating procedures, regulatory guidelines, executed client contracts, and clients’ expectations.

In this role you key task will include:

  • Assist in developing and implementing a CSV strategy.
  • Support the lifecycle of computerized system validation activities.
  • Participate in risk assessments to help 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 help ensure data is accurate, secure, consistent, and reliable throughout its lifecycle.
  • 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 (future) key accounts.
  • Support in the preparation of new proposals.
  • Contribute and take part in client evaluations, visits and bid defenses.

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, andclient-focusedd.
  • 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

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

  • Sr. Validation And Compliance Lead

    1 day ago

    Bracknell, United Kingdom Allucent Full time

    At 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 (India) to join our A-team (hybrid*).As a Senior Validation and Compliance Lead will be responsible...

  • Sr. Validation And Compliance Lead

    1 day ago

    Bracknell, United Kingdom Allucent Full time

    At 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 (India) to join our A-team (hybrid*).As a Senior Validation and Compliance Lead will be responsible...

  • Sr. Validation and Compliance Lead

    3 days ago

    Bracknell, United Kingdom Allucent Full time

    At 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 (India) to join our A-team (hybrid*). As a Senior Validation and Compliance Lead will be responsible...

  • Sr. Manager

    2 months ago

    Bracknell, United Kingdom Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Sr. Manager / Associate Director, Talent Acquisition to join our A-team (hybrid*). As a Sr. Manager / Associate Director, Talent...

  • Sr Account Executive I

    6 months ago

    Bracknell, United Kingdom Cadence Design Systems Full time

    At Cadence, we hire and develop leaders and innovators who want to make an impact on the world of technology. - In this role, the Senior Account Executive is responsible for developing and driving a business strategy that leads to adoption and growth of the Cadence Systems Solutions which include Allegro PCB, IC Packaging and multi-physics analysis in their...

  • Regulatory Compliance Lead

    5 months ago

    Bracknell, United Kingdom Berkshire Healthcare NHS Foundation Trust Full time

    The Regulatory Compliance Lead has a wide range of responsibilities, including but not limited to: Leading the year-round CQC preparation work for the organi s ation Coordinating the response to clinical concerns that come into the organi s ation. Providing support to ensure appropriate information is provided to NHSR for any claims received into the...

  • Risk & Compliance Lead

    6 months ago

    Bracknell, United Kingdom Snow Software Full time

    **Job Description**: Snow has achieved ISO27001 and CSA Star 1 and is working towards SOC2 Type 2 compliance and need someone who can help manage risk and compliance within the IT Security team. You’ll be a key member of the team reporting to Snow’s security leader and will be involved in audit management, risk management, security assessments,...

  • Product Compliance Specialist

    1 month ago

    Bracknell, Bracknell Forest, United Kingdom Bridgewater Resources UK Ltd Full time

    Bridgewater Resources UK Ltd is seeking a Product Compliance Specialist to join their team in Bracknell. As a Product Compliance Specialist, you will be responsible for ensuring CE compliance and conformance from manufacturing partners. Your key tasks will include product documentation creation and specification validation, as well as working closely with...

  • Finance & Master data, compliance lead

    5 days ago

    Bracknell, United Kingdom Spinks Full time

    Day rate: £400 - £450 (Inside IR35)Length: 6 Months (Hybrid working in Bracknell)Spinks have partnered up with a global leading automotive client who are looking to bring on a finance and master data compliance lead to the team to assist on their delivery of technical and functional support specific to Master Data & Compliance across each tower.Key Skills:...

  • Finance & Master data, compliance lead

    2 weeks ago

    Bracknell, United Kingdom CV-Library Full time

    Day rate: £400 - £450 (Inside IR35) Length: 6 Months (Hybrid working in Bracknell) Spinks have partnered up with a global leading automotive client who are looking to bring on a finance and master data compliance lead to the team to assist on their delivery of technical and functional support specific to Master Data & Compliance across each...

  • Finance Master Data And Compliance Lead

    15 hours ago

    Bracknell, United Kingdom Marc Daniels Full time

    The Finance master Data Management (MDM) and Compliance (Contractor) will play a critical role in ensuring the integrity, accuracy, and security of Finance master data across the enterprise.This includes the development and execution of strategies for Finance master data management, the establishment of robust data governance policies, and the oversight of...

  • Finance Master Data and Compliance Lead

    3 days ago

    Bracknell, United Kingdom CV-Library Full time

    The Finance master Data Management (MDM) and Compliance (Contractor) will play a critical role in ensuring the integrity, accuracy, and security of Finance master data across the enterprise. This includes the development and execution of strategies for Finance master data management, the establishment of robust data governance policies, and the oversight of...

  • Finance & Master data, compliance lead

    2 weeks ago

    Bracknell, United Kingdom Spinks Full time

    Day rate: £400 - £450 (Inside IR35)Length: 6 Months (Hybrid working in Bracknell)Spinks have partnered up with a global leading automotive client who are looking to bring on a finance and master data compliance lead to the team to assist on their delivery of technical and functional support specific to Master Data & Compliance across each tower.Key Skills:...

  • Contract Compliance Manager

    3 weeks ago

    Bracknell, United Kingdom Signet Recruitment and Retention Full time

    Compliance and Risk Department Manager (contract) Location – Bracknell.Salary - £550 - £650 a day Inside IR35.Duration - 12 Months -potential temporary to permanent role. Hybrid – 3 days a week in the office 2 days from home -35 hrs a week.The Opportunity:We are excited to share this opportunity for a Compliance and Risk Department Manager to join,...

  • Contract Compliance Manager

    2 weeks ago

    Bracknell, United Kingdom Signet Recruitment and Retention Full time

    Job Description Compliance and Risk Department Manager (contract) Location – Bracknell. Salary - £550 - £650 a day Inside IR35. Duration - 12 Months -potential temporary to permanent role. Hybrid – 3 days a week in the office 2 days from home -35 hrs a week. The Opportunity: We are excited to share this opportunity for a Compliance and Risk...

  • Contract Compliance Manager

    2 months ago

    Bracknell, United Kingdom Signet Recruitment and Retention Full time

    Compliance and Risk Department Manager (contract) Location – Bracknell.Salary - £550 - £650 a day Inside IR35.Duration - 12 Months -potential temporary to permanent role. Hybrid – 3 days a week in the office 2 days from home -35 hrs a week.The Opportunity:We are excited to share this opportunity for a Compliance and Risk Department Manager to join,...

  • Contract Compliance Manager

    2 months ago

    Bracknell, United Kingdom Signet Recruitment and Retention Full time

    Compliance and Risk Department Manager (contract) Location – Bracknell.Salary - £550 - £650 a day Inside IR35.Duration - 12 Months -potential temporary to permanent role. Hybrid – 3 days a week in the office 2 days from home -35 hrs a week.The Opportunity:We are excited to share this opportunity for a Compliance and Risk Department Manager to join,...

  • Contract Compliance Manager

    3 weeks ago

    Bracknell, United Kingdom Signet Recruitment and Retention Full time

    Compliance and Risk Department Manager (contract) Location – Bracknell.Salary - £550 - £650 a day Inside IR35.Duration - 12 Months -potential temporary to permanent role. Hybrid – 3 days a week in the office 2 days from home -35 hrs a week.The Opportunity:We are excited to share this opportunity for a Compliance and Risk Department Manager to join,...

  • Clinical Compliance Lead

    6 days ago

    Bracknell, Bracknell Forest, United Kingdom HealthHero Full time

    HealthHero, a leading European healthcare provider, seeks an experienced Regulatory Quality Expert to join its Clinical Product Team. This exciting opportunity will challenge you to develop and implement effective quality management systems that meet the evolving needs of our business.We are seeking a highly skilled individual who possesses in-depth...

  • Regulatory Compliance Lead

    6 months ago

    Bracknell, United Kingdom Berkshire Healthcare Foundation Trust Full time

    **The must haves for this role**: Extensive experience of embedding strong governance to manage regulatory compliance. A good understanding of the CQC process Experience of facilitating education/workshops with stakeholders Ability to work strategically and at all levels across organisational and professional boundaries and at the patient level. Ability to...