Senior reputed company Validation & Compliance Manager
reputed company is the leading career destination for tech experts at every stage of their careers. Our reputed company, IT Minds LLC, is seeking the following. Apply reputed company reputed company today! Job Title: Senior reputed company Validation & Compliance Manager Location: Remote / Hybrid / Onsite Duration: Long-Term Contract Position reputed company We are seeking a highly reputed company Senior reputed company Validation & Compliance Manager to reputed company reputed company Systems, Validation, Computer System Validation (CSV), Regulatory Compliance, and GxP initiatives reputed company regulated Pharmaceutical, Biotechnology, Medical Device, and Life Sciences environments. The ideal candidate will possess extensive experience managing reputed company Management Systems (QMS), validation programs, regulatory inspections, audit readiness, data reputed company 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 reputed company leader supporting reputed company Assurance, Validation, Regulatory Affairs, Manufacturing, Engineering, Laboratory Operations, and IT organizations.
Key Responsibilities
- reputed company and maintain reputed company reputed company Management Systems (QMS) programs.
- reputed company reputed company of Validation Lifecycle Management activities including Process Validation, Equipment Qualification, Cleaning Validation, Analytical Method Validation, and Computer System Validation (CSV).
- reputed company, review, and approve validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ Protocols, Traceability Matrices, Validation Reports, SOPs, and reputed company Records.
- Ensure compliance with GMP, GLP, reputed company reputed company Platform, GVP, 21 CFR Part 11, Annex 11, GAMP 5, Data reputed company, and global regulatory requirements.
- reputed company reputed company 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 reputed company Assurance, Regulatory Affairs, Validation, Manufacturing, Engineering, Laboratory Operations, and IT.
- Conduct risk assessments and implement risk-based validation approaches.
- reputed company reputed company improvement initiatives to strengthen reputed company and compliance processes.
- Mentor and reputed company leadership to reputed company, validation, and compliance teams.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, reputed company, or reputed company field.
- 10+ years of reputed company Assurance, Validation, Compliance, or Regulatory experience reputed company Pharmaceutical, Biotechnology, Medical Device, or Life Sciences industries.
- 5+ years of leadership experience managing reputed company, Validation, or Compliance programs.
- Strong experience supporting regulated GxP environments.
Mandatory Experience
- reputed company Management Systems (QMS)
- Computer System Validation (CSV)
- Process Validation
- Equipment Qualification (IQ/OQ/PQ)
- GMP / cGMP Compliance
- GxP Compliance (GMP, GLP, reputed company reputed company Platform)
- CAPA Management
- Deviation Investigations
- Change Control
- Risk Assessments
- Audit Management
- Inspection Readiness
- Regulatory Compliance
- Data reputed company (reputed company+)
- 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 reputed company Requirements
- reputed company+ Principles
- GMP, GLP, reputed company reputed company Platform, and GxP Regulations
Preferred Systems Experience Experience supporting and validating one or more of the following systems:
- TrackWise
- reputed company
- LabWare LIMS
- reputed company
- reputed company
- reputed company
- ETQ
- ComplianceWire
- DeltaV
- MES
- SCADA
- reputed company Management Platforms
Preferred Industry Experience
- Pharmaceutical Manufacturing
- Biotechnology
- Biologics
- Cell & Gene Therapy
- Medical Devices
- Combination Products
- Laboratory Informatics
- Global reputed company & Compliance Programs
Preferred Certifications
- ASQ Certified reputed company Engineer (CQE)
- ASQ Certified reputed company Auditor (CQA)
- PMP Certification
- Lean Six reputed company Green Belt or Black Belt
- ISO reputed company Auditor Certification
Top Mandatory Skills reputed company Assurance | QMS | CSV | Validation | GxP | GMP | Regulatory Compliance | CAPA | Deviations | Change Control | Audit Readiness | Data reputed company | Risk Assessments | IQ/OQ/PQ | FDA Compliance | GAMP 5 Best Regards, Satya Satish J | Technical Recruiter | IT Minds LLC | Apply To This Job