Faiz Khan

Angestellt, Associate Director Clinical QA, Manager GCP QA, MorphoSys AG

München, Deutschland

Über mich

I have several years of experience in leading and conducting audits for clinical trials in oncology and other therapeutic areas. I am an experienced auditor in GCP, GCLP, and GLP, and I have a deep understanding of international regulations, ISO standards, and inspection readiness. My core competencies include developing and implementing risk-based audit strategies, managing cross-functional teams, acting as a GCP expert for ongoing projects, and ensuring quality and compliance throughout the clinical development process. I collaborate with various stakeholders, such as clinical operations (CTT), medical affairs, data management, and suppliers. I have a proven track record in delivering high-quality audits for CROs, TMFs, CSVs, data integrity, investigator sites, systems, and suppliers, covering Phase I-IV trials. My mission is to support MorphoSys in developing and delivering innovative and effective oncology treatments for patients.

Fähigkeiten und Kenntnisse

FMEA
Audit
Clinical Trials
GCP
GLP
GMP
GMP Compliance
CRO
CAPA
Investigation
Pharma
audit
Inspection readiness
FDA
Quality Management
Management
Project Management
Clinical Trial
Leadership
Flexibility
quality driven
ISO 9000
Qualitätsmanagement
Quality Assurance
cGMP
GMP-Compliance
GCP Audits
Clinical Research
ISO
CTMS
QC
GPvP
GDP
GDPR
Quality system
Quality Audits
Data Quality
MS Office
English Language
QMS
CTT
Regulatory Complaince
Inspection planning
inspection readiness
Submision
Due Diligence
Vendor Management
Vendor qualification
Serious Breach
QUality Issue

Werdegang

Berufserfahrung von Faiz Khan

  • Bis heute 1 Jahr und 10 Monate, seit Aug. 2022

    Associate Director Clinical QA, Manager GCP QA

    MorphoSys AG

    The role involves leading GCP projects, implementing risk-based audit strategies, and developing Quality Management documents. As a GCP expert, responsibilities include planning and conducting audits, collaborating with consultants, and guiding cross-functional teams.

  • 6 Jahre und 2 Monate, Juni 2016 - Juli 2022

    QA Manager

    Abbott

    Conduct Good Clinical Practice (GCP) audits, Including Contract Research Organizations (CRO) Qualification, Trial Master Files (TMF) audit, Computer system validation (CSV) audit, data integrity, Investigator site audit etc.

  • 1 Jahr und 7 Monate, Nov. 2014 - Mai 2016

    Technical Training Manager

    julphar

  • 2 Jahre, Apr. 2012 - März 2014

    Quality Control Analyst

    Cipla Ltd

Sprachen

  • Englisch

    Fließend

  • Deutsch

    Grundlagen

  • hindi

    Muttersprache

Interessen

Reading
Music
swimming

21 Mio. XING Mitglieder, von A bis Z