Live opening · Posted 2 days ago

Senior Life Sciences Compliance Specialist

US Recruiter Choose Your Career · United Arab Emirates (Remote)
Linkedin Yes
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At a glance

The key details from the original listing.

Posted 2 days ago
CompanyUS Recruiter Choose Your Career
LocationUnited Arab Emirates (Remote)
Work modeYes
SkillsGCP
SourceLinkedin
ListedPosted 2 days ago

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About the role

Description supplied by the original job listing.

🏗 We're Hiring: Senior Life Sciences Compliance Specialist
Location: United Arab Emirates (Remote)
Employment Type: Full-Time
Experience Level: Mid-Level to Senior
Work Arrangement: Fully Remote
About Us
We are a construction-focused organization committed to delivering complex projects through disciplined contract management, commercial excellence, risk control, and collaborative project delivery. Our distributed teams collaborate across Project Management, Construction, Engineering, Procurement, Commercial, Legal, Finance, Human Resources, Design, Quality, HSE, Consultants, Contractors, Suppliers, Logistics, Administration, Information Technology, and Executive Leadership to maintain high standards of operational integrity, regulatory compliance, quality assurance, and professional accountability across diverse industries and business functions.
We value precision, transparency, continuous improvement, and responsible business practices. By combining structured governance with practical risk management, we aim to ensure that our operations, partnerships, and project activities meet applicable regulatory requirements and recognized industry standards.
The Role
We are seeking an experienced Senior Life Sciences Compliance Specialist to oversee, coordinate, and strengthen compliance programs related to life sciences, pharmaceutical operations, biotechnology, medical products, laboratory activities, clinical research, and other regulated environments relevant to our business operations. The ideal candidate will bring strong expertise in regulatory compliance, quality management systems, risk assessment, controlled documentation, audit preparation, and industry-specific standards.
This role will focus on interpreting applicable regulatory requirements, evaluating compliance risks, supporting internal governance frameworks, monitoring corrective and preventive actions, and promoting a culture of quality, ethics, and accountability. The Senior Life Sciences Compliance Specialist will collaborate with Quality Assurance, Legal, Procurement, Engineering, Project Management, HSE, external consultants, laboratories, suppliers, contractors, and senior leadership to ensure that relevant activities are conducted in accordance with applicable United Arab Emirates laws and regulations, recognized international standards, contractual obligations, and organizational policies.
Key Responsibilities
Develop, implement, maintain, and continuously improve life sciences compliance policies, procedures, standards, and operational guidelines.
Monitor applicable regulatory requirements affecting pharmaceutical, biotechnology, medical device, laboratory, clinical research, and related life sciences activities.
Interpret relevant laws, regulations, industry standards, and regulatory guidance and communicate their operational implications to internal stakeholders.
Support compliance with applicable UAE regulatory requirements and relevant international frameworks, as appropriate to the organization's activities.
Establish and maintain compliance monitoring plans, assessment schedules, reporting procedures, and escalation protocols.
Conduct compliance risk assessments to identify regulatory gaps, process weaknesses, control deficiencies, and potential operational exposures.
Evaluate business processes, technical activities, and supplier arrangements against applicable quality and compliance requirements.
Maintain regulatory obligation registers, compliance matrices, control inventories, and evidence records.
Support the development and maintenance of quality management systems aligned with relevant life sciences requirements.
Promote appropriate application of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP), where applicable.
Review standard operating procedures, work instructions, quality manuals, policies, and controlled documents for regulatory alignment.
Ensure compliance documentation is accurate, current, traceable, approved, and maintained according to document control requirements.
Coordinate internal compliance audits, readiness reviews, process inspections, and periodic control assessments.
Prepare teams for external audits, regulatory inspections, customer assessments, and third-party compliance reviews.
Support the collection, organization, validation, and presentation of audit evidence and regulatory documentation.
Identify nonconformities, document observations, assess root causes, and coordinate appropriate corrective and preventive actions.
Monitor CAPA plans to ensure that assigned actions are completed on time and demonstrate measurable effectiveness.
Investigate recurring compliance issues and recommend sustainable improvements to prevent similar findings.
Review change control requests to evaluate potential impacts on regulatory compliance, product quality, validation status, and controlled processes.
Support risk-based evaluation of changes involving facilities, equipment, materials, suppliers, processes, software, and operational procedures.
Assess supplier and service-provider compliance documentation, qualifications, certifications, and quality records.
Participate in supplier qualification, due diligence, performance reviews, and risk-based audit programs.
Collaborate with Procurement and Contract Management teams to incorporate appropriate regulatory, quality, traceability, and documentation requirements into supplier agreements.
Evaluate outsourced activities and third-party services for compliance risks, accountability, and oversight requirements.
Support qualification and validation activities involving facilities, equipment, utilities, computerized systems, analytical methods, and production processes, where applicable.
Review validation plans, protocols, reports, and supporting evidence for completeness and alignment with approved requirements.
Monitor data integrity practices and promote reliable, attributable, legible, contemporaneous, original, and accurate records.
Assess controls for electronic records, electronic signatures, system access, audit trails, data retention, and controlled information management.
Support the implementation of appropriate computerized system validation and lifecycle control practices.
Coordinate with IT and cybersecurity teams to address compliance risks involving regulated systems, sensitive information, and electronic documentation.
Review procedures for the secure handling, storage, transfer, retention, and disposal of regulated records and life sciences information.
Support compliance activities relating to product quality, product traceability, labeling, packaging, storage, transportation, and distribution, where relevant.
Assist in evaluating product deviations, quality complaints, out-of-specification results, and other events requiring formal investigation.
Support the assessment and documentation of potential product quality issues and their impact on regulatory obligations.
Coordinate with relevant stakeholders on product recall readiness, incident escalation, and traceability exercises, where applicable.
Review processes associated with clinical research, human-subject protection, informed consent, and clinical trial documentation when these activities fall within the organization's scope.
Support compliance with applicable ethical review, research governance, and clinical data management requirements.
Assist with the assessment of pharmacovigilance, product safety, adverse event reporting, or post-market surveillance obligations where relevant to assigned operations.
Evaluate laboratory practices, sample management procedures, testing records, and equipment controls against applicable standards.
Support the assessment of environmental, health, and safety requirements associated with laboratories, controlled materials, and specialized life sciences facilities.
Collaborate with Engineering, Construction, and Facilities teams to review compliance considerations for laboratories, cleanrooms, controlled environments, and regulated operational spaces.
Review facility design, commissioning, qualification, and handover documentation for alignment with applicable quality and regulatory expectations.
Coordinate with HSE and technical teams to evaluate risks associated with hazardous materials, biological agents, chemical handling, waste management, and emergency preparedness, where applicable.
Maintain compliance training matrices and ensure that personnel complete required training within established timelines.
Develop and deliver training sessions covering regulatory awareness, quality systems, documentation practices, data integrity, audit readiness, and compliance responsibilities.
Evaluate training effectiveness and identify additional learning needs based on audit findings, incidents, and regulatory changes.
Provide practical guidance to employees and managers on interpreting compliance requirements and applying approved procedures.
Serve as a subject-matter resource for compliance-related questions, investigations, audit findings, and corrective action planning.
Monitor regulatory updates, industry developments, inspection trends, and emerging compliance risks that may affect organizational operations.
Assess the impact of new or revised requirements and coordinate implementation plans with responsible departments.
Maintain effective commu

Work arrangement
Yes

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