Job Description

We're Hiring: Senior GMP Specialist

Location: United Arab Emirates (Remote)

Employment Type: Full-Time

Experience Level: Senior

Work Arrangement: Fully Remote

About Us

We are a globally focused organization committed to maintaining high standards of pharmaceutical quality, manufacturing excellence, regulatory compliance, and patient safety across diverse markets.

Our Quality and Operations teams collaborate across Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Engineering, Validation, Supply Chain, Technology, and external partners to ensure that products are manufactured, tested, stored, and distributed in accordance with applicable Good Manufacturing Practice requirements.

The Role

We are seeking an experienced Senior GMP Specialist to provide expert guidance on Good Manufacturing Practice compliance, quality systems, manufacturing controls, documentation, investigations, CAPA, change control, audits, inspection readiness, and continuous improvement.

The ideal candidate will support the implementation and maintenance of robust GMP standards across regulated operations, identify compliance risks, strengthen quality processes, support regulatory inspections, and promote a proactive culture of quality and manufacturing excellence.

Key Responsibilities

Develop and maintain GMP compliance strategies, policies, standards, procedures, and governance frameworks.
Interpret applicable GMP regulations, regulatory guidance, pharmacopoeial requirements, and industry standards.
Monitor changes in GMP requirements and assess their impact on manufacturing and quality operations.
Provide expert GMP guidance to Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, Supply Chain, and other functions.
Monitor GMP compliance across manufacturing, packaging, testing, storage, and related operational activities.
Conduct GMP compliance assessments, gap analyses, and risk assessments.
Identify GMP deficiencies, quality risks, control weaknesses, and opportunities for improvement.
Support implementation of risk-based quality-management practices.
Develop and maintain GMP compliance monitoring programs.
Conduct internal GMP audits and quality-system assessments.
Participate in supplier, contract manufacturer, contract laboratory, and service-provider audits.
Prepare audit plans, checklists, reports, observations, and follow-up documentation.
Support regulatory inspections by health authorities and other applicable regulatory bodies.
Coordinate inspection-readiness activities and ensure required documentation is current and readily accessible.
Support preparation of responses to regulatory observations and inspection findings.
Track regulatory commitments and verify timely completion of corrective actions.
Lead or support investigations into GMP deviations, non-conformances, quality events, and manufacturing failures.
Perform or facilitate root-cause analysis using appropriate investigation methodologies.
Develop, monitor, and evaluate corrective and preventive action plans.
Assess CAPA effectiveness and verify sustainable resolution of identified issues.
Review deviations, out-of-specification results, out-of-trend results, environmental-monitoring events, and other quality incidents for GMP impact.
Evaluate the potential product-quality, patient-safety, and regulatory impact of manufacturing events.
Support change-control processes and assess GMP and regulatory implications of proposed changes.
Review and approve GMP-related change-control documentation where authorized.
Develop, review, and maintain Standard Operating Procedures, work instructions, forms, protocols, and GMP guidance documents.
Ensure GMP documentation is accurate, complete, controlled, traceable, and appropriately maintained.
Monitor compliance with good documentation practices and data-integrity requirements.
Review batch records, manufacturing documentation, logbooks, protocols, reports, and other GMP records as required.
Identify documentation errors, recurring deficiencies, and opportunities to improve recordkeeping practices.
Support batch-record review and release processes where applicable.
Monitor manufacturing processes for adherence to approved procedures, specifications, and established controls.
Support process-validation and continued-process-verification activities.
Work with Validation and Engineering teams on equipment, facility, utility, cleaning, and process qualification activities.
Provide GMP input into facility design, equipment selection, process changes, and manufacturing improvements.
Support qualification and validation programs for GMP-critical equipment and systems.
Review validation protocols, reports, deviations, and supporting documentation for GMP compliance.
Monitor environmental, hygiene, contamination-control, and facility-compliance requirements.
Support contamination-control strategies and programs where applicable.
Assess risks associated with cross-contamination, mix-ups, foreign materials, microbial contamination, and other manufacturing hazards.
Support cleaning-validation and sanitation programs where applicable.
Evaluate manufacturing practices, personnel flows, material flows, and facility controls from a GMP perspective.
Support warehouse and material-management processes to ensure GMP compliance.
Monitor controls covering receipt, identification, quarantine, sampling, storage, dispensing, handling, and distribution of materials.
Support GMP requirements for temperature-controlled and environmentally sensitive materials where applicable.
Evaluate contract manufacturers, suppliers, and outsourced GMP activities.
Support qualification and periodic review of GMP-critical suppliers and service providers.
Review quality agreements, technical agreements, and GMP responsibilities with external partners.
Monitor supplier quality performance and coordinate corrective actions for identified GMP issues.
Develop and deliver GMP training, awareness programs, workshops, and compliance briefings.
Monitor GMP training completion and competency for personnel performing regulated activities.
Promote strong GMP awareness and quality ownership throughout the organization.
Support periodic GMP self-inspections, walkthroughs, shop-floor assessments, and compliance observations.
Conduct quality and GMP walkthroughs to identify potential risks before they become significant findings.
Establish and monitor GMP compliance metrics, trends, and performance indicators.
Analyze recurring deviations, audit observations, CAPAs, complaints, and other quality signals to identify systemic issues.
Prepare GMP compliance reports and dashboards for Quality leadership and senior management.
Support regulatory submissions and responses by providing GMP-related information and documentation where required.
Collaborate with Regulatory Affairs on manufacturing changes, regulatory commitments, inspections, and authority interactions.
Support product-quality reviews and periodic quality assessments where applicable.
Evaluate the GMP implications of new products, manufacturing processes, technologies, facilities, systems, and suppliers.
Support technology and automation initiatives that improve GMP compliance, documentation, traceability, and operational control.
Maintain accurate GMP compliance records, audit reports, inspection documentation, CAPA records, risk assessments, training records, and quality-system documentation.
Escalate significant GMP risks, critical observations, and potential regulatory concerns to appropriate leadership.
Provide recommendations to management on GMP remediation, quality improvements, compliance priorities, and operational risks.
Support continuous-improvement initiatives that improve manufacturing consistency, product quality, compliance, and operational efficiency.

Key Performance Indicators

GMP compliance rate
Internal GMP audit completion
Regulatory inspection readiness
Regulatory inspection findings
Critical and major GMP observations
GMP observation closure rate
CAPA closure timeliness
CAPA effectiveness rate
Deviation closure time
Deviation recurrence rate
Manufacturing deviation rate
Batch-record right-first-time performance
Batch-record review accuracy
Good documentation practice compliance
Data-integrity compliance
Change-control compliance
Change-control cycle time
OOS investigation completion
OOT investigation completion
Root-cause analysis effectiveness
Quality-event investigation timeliness
Process-validation compliance
Equipment qualification compliance
Cleaning-validation compliance
Environmental-monitoring compliance
Contamination-control compliance
Facility GMP compliance
Supplier GMP compliance
Supplier audit performance
Quality-agreement completion
GMP training completion
GMP training effectiveness
Personnel competency compliance
Self-inspection completion
Audit finding recurrence
Regulatory commitment completion
Inspection-response timeliness
GMP risk-assessment completion
High-risk GMP issue remediation
Quality-system improvement completion
GMP compliance reporting timeliness
Manufacturing process compliance
Product-quality trend performance
Continuous-improvement implementation

Ideal Candidate

The successful candidate should have strong experience in Good Manufacturing Practice, pharmaceutical manufacturing, quality assurance, quality compliance, production quality, validation, or regulated life-sciences operations, preferably within pharmaceutical, biotechnology, medical-device, sterile manufacturing, API, or other highly regulated environments.

The candidate should demonstrate:

Strong knowledge of current GMP principles and regulatory expectations.
Practical experience applying GMP requirements within manufacturing or regulated operational environments.
Strong understanding of pharmaceutical quality systems and GMP governance.
Experience conducting GMP audits, self-inspections, compliance assessments, and gap analyses.
Experience supporting regulatory inspections and remediation of inspection findings.