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.”
Equal Employment Opportunity and Affirmative Action. Allucent (US) LLC is committed to Equal Employment Opportunity and Affirmative Action. We recruit, hire, train and promote qualified persons in all job titles and ensure that all other personnel actions are administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, marital status, military and/or veteran status, or disability. Furthermore, to the extent required by applicable laws and/or Executive Orders, we take affirmative action to ensure that minority group individuals, females, disabled veterans, recently separated veterans, other protected veterans, Armed Forces service medal veterans, and qualified disabled persons are introduced into our workforce and considered for promotional opportunities. Allucent (US) LLC is committed to providing reasonable accommodations to employees and applicants with disabilities to the full extent required by the Americans with Disabilities Act - ADA. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 919.361.2286.
