Job Title: Senior Quality Validation & Compliance Manager
Location: Remote / Hybrid / Onsite
Duration: Long-Term Contract
Position Overview
We are seeking a highly experienced Senior Quality Validation & Compliance Manager to lead Quality Systems, Validation, Computer System Validation (CSV), Regulatory Compliance, and GxP initiatives within regulated Pharmaceutical, Biotechnology, Medical Device, and Life Sciences environments.
The ideal candidate will possess extensive experience managing Quality Management Systems (QMS), validation programs, regulatory inspections, audit readiness, data integrity initiatives, and compliance activities while ensuring adherence to FDA, EMA, MHRA, ICH, GAMP 5, and global GxP requirements.
This role will serve as a key quality leader supporting Quality Assurance, Validation, Regulatory Affairs, Manufacturing, Engineering, Laboratory Operations, and IT organizations.
Key Responsibilities
- Lead and maintain enterprise Quality Management Systems (QMS) programs.
- Provide oversight of Validation Lifecycle Management activities including Process Validation, Equipment Qualification, Cleaning Validation, Analytical Method Validation, and Computer System Validation (CSV).
- Develop, review, and approve validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, Validation Reports, SOPs, and Quality Records.
- Ensure compliance with GMP, GLP, Google Cloud Platform, GVP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity, and global regulatory requirements.
- Lead quality investigations, deviations, CAPAs, change controls, non-conformances, and remediation activities.
- Support FDA, EMA, MHRA, ISO, and customer inspections and audits.
- Drive inspection readiness programs and regulatory compliance initiatives.
- Partner with cross-functional teams including Quality Assurance, Regulatory Affairs, Validation, Manufacturing, Engineering, Laboratory Operations, and IT.
- Conduct risk assessments and implement risk-based validation approaches.
- Lead continuous improvement initiatives to strengthen quality and compliance processes.
- Mentor and provide leadership to quality, validation, and compliance teams.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, or related field.
- 10+ years of Quality Assurance, Validation, Compliance, or Regulatory experience within Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.
- 5+ years of leadership experience managing Quality, Validation, or Compliance programs.
- Strong experience supporting regulated GxP environments.
Mandatory Experience
- Quality Management Systems (QMS)
- Computer System Validation (CSV)
- Process Validation
- Equipment Qualification (IQ/OQ/PQ)
- GMP / cGMP Compliance
- GxP Compliance (GMP, GLP, Google Cloud Platform)
- CAPA Management
- Deviation Investigations
- Change Control
- Risk Assessments
- Audit Management
- Inspection Readiness
- Regulatory Compliance
- Data Integrity (ALCOA+)
- Validation Lifecycle Management
Regulatory & Compliance Expertise
Strong knowledge of:
- FDA Regulations
- 21 CFR Part 11
- 21 CFR Parts 210, 211, and 820
- EU Annex 11
- GAMP 5
- ICH Guidelines
- ISO 13485
- Data Integrity Requirements
- ALCOA+ Principles
- GMP, GLP, Google Cloud Platform, and GxP Regulations
Preferred Systems Experience
Experience supporting and validating one or more of the following systems:
- TrackWise
- Veeva
- LabWare LIMS
- Empower
- SAP
- MasterControl
- ETQ
- ComplianceWire
- DeltaV
- MES
- SCADA
- Quality Management Platforms
Preferred Industry Experience
- Pharmaceutical Manufacturing
- Biotechnology
- Biologics
- Cell & Gene Therapy
- Medical Devices
- Combination Products
- Laboratory Informatics
- Global Quality & Compliance Programs
Preferred Certifications
- ASQ Certified Quality Engineer (CQE)
- ASQ Certified Quality Auditor (CQA)
- PMP Certification
- Lean Six Sigma Green Belt or Black Belt
- ISO Lead Auditor Certification
Top Mandatory Skills
Quality Assurance | QMS | CSV | Validation | GxP | GMP | Regulatory Compliance | CAPA | Deviations | Change Control | Audit Readiness | Data Integrity | Risk Assessments | IQ/OQ/PQ | FDA Compliance | GAMP 5
Best Regards,
Satya Satish J | Technical Recruiter | IT Minds LLC |
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