Muhammad Saleem
QA Lead with 10+ years in GMP compliance for biologics, cell/gene therapy & combo products. Expert in FDA/EMA readiness.
A highly experienced Quality Assurance Lead with over 10 years in the pharmaceutical and biologics industry, specializing in GMP compliance and regulatory readiness for sterile manufacturing. Proven expertise in leading quality programs, directing CAPA and risk management (FMEA/RCA), and supervising batch release for complex products including cell & gene therapies and combination products. Adept at managing CMOs, supporting IND/BLA submissions, and ensuring successful FDA/EMA interactions. Offers robust support for pharmaceutical medical devices, including sterilization validation and regulatory compliance. Combines deep technical knowledge with strong leadership to drive product quality and ensure inspection readiness for medical device and pharma clients.
About
A highly experienced Quality Assurance Lead with over 10 years in the pharmaceutical and biologics industry, specializing in GMP compliance and regulatory readiness for sterile manufacturing. Proven expertise in leading quality programs, directing CAPA and risk management (FMEA/RCA), and supervising batch release for complex products including cell & gene therapies and combination products. Adept at managing CMOs, supporting IND/BLA submissions, and ensuring successful FDA/EMA interactions. Offers robust support for pharmaceutical medical devices, including sterilization validation and regulatory compliance. Combines deep technical knowledge with strong leadership to drive product quality and ensure inspection readiness for medical device and pharma clients.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 10
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC
- **Client types:** sme, large_medtech, academic
- **Location:** United States (New Jersey)
- **Availability:** available_now
- **Certifications:** Six Sigma Green Belt & Black Belt Certification, FPGEE, First Aid, CPR
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### **Cruxi analysis**
- **Strength summary:** With over 10 years of specialized experience in the pharmaceutical and biologics sectors, Muhammad Saleem offers medtech companies profound expertise in Quality Assurance for complex and highly regulated products. His deep knowledge of GMP compliance, sterile manufacturing, and risk management (FMEA/RCA) is critical for organizations developing combination products, cell & gene therapies, or sterile medical devices. Having led quality programs and managed successful FDA/EMA interactions at major firms like Pfizer, he provides a proven framework for establishing robust Quality Management Systems. His expertise in sterilization validation, CAPA direction, and post-market support makes him an invaluable asset for ensuring audit readiness and maintaining the highest standards of product quality and regulatory compliance.
- **Unique value:** Muhammad Saleem's unique value is his specialized expertise at the intersection of pharmaceutical GMP standards and medical device quality systems. His background as a Doctor of Pharmacy, coupled with hands-on leadership in cutting-edge biologics and cell & gene therapy, provides medtech companies with a rare and powerful perspective for ensuring the quality and compliance of their most complex combination products.
- **Ideal projects:** The ideal project for Muhammad Saleem involves a small-to-large medtech company or academic institution developing a combination product or a sterile medical device requiring rigorous quality oversight. He is a perfect fit for clients needing to establish a new QMS, achieve ISO 13485 compliance, or prepare for an FDA or EMA inspection. Companies facing challenges with post-market compliance, CAPA resolution, or risk management (ISO 14971) for complex therapeutic devices would benefit immensely from his guidance. Engaging him is most impactful when scaling manufacturing operations, managing CMO quality, or ensuring the regulatory integrity of a product portfolio that bridges pharmaceutical and medical device standards.
- **Last analyzed:** Mon Dec 22 2025 11:56:59 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** clinical-trials, qms
- **Specialties:** hematology, pathology, general-hospital, other
- **Device panels:** general_surgery, other
- **Regulatory pathways:** post_market
---
- **Type:** independent
- **Years of experience:** 10
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU, APAC
- **Client types:** sme, large_medtech, academic
- **Location:** United States (New Jersey)
- **Availability:** available_now
- **Certifications:** Six Sigma Green Belt & Black Belt Certification, FPGEE, First Aid, CPR
---
### **Cruxi analysis**
- **Strength summary:** With over 10 years of specialized experience in the pharmaceutical and biologics sectors, Muhammad Saleem offers medtech companies profound expertise in Quality Assurance for complex and highly regulated products. His deep knowledge of GMP compliance, sterile manufacturing, and risk management (FMEA/RCA) is critical for organizations developing combination products, cell & gene therapies, or sterile medical devices. Having led quality programs and managed successful FDA/EMA interactions at major firms like Pfizer, he provides a proven framework for establishing robust Quality Management Systems. His expertise in sterilization validation, CAPA direction, and post-market support makes him an invaluable asset for ensuring audit readiness and maintaining the highest standards of product quality and regulatory compliance.
- **Unique value:** Muhammad Saleem's unique value is his specialized expertise at the intersection of pharmaceutical GMP standards and medical device quality systems. His background as a Doctor of Pharmacy, coupled with hands-on leadership in cutting-edge biologics and cell & gene therapy, provides medtech companies with a rare and powerful perspective for ensuring the quality and compliance of their most complex combination products.
- **Ideal projects:** The ideal project for Muhammad Saleem involves a small-to-large medtech company or academic institution developing a combination product or a sterile medical device requiring rigorous quality oversight. He is a perfect fit for clients needing to establish a new QMS, achieve ISO 13485 compliance, or prepare for an FDA or EMA inspection. Companies facing challenges with post-market compliance, CAPA resolution, or risk management (ISO 14971) for complex therapeutic devices would benefit immensely from his guidance. Engaging him is most impactful when scaling manufacturing operations, managing CMO quality, or ensuring the regulatory integrity of a product portfolio that bridges pharmaceutical and medical device standards.
- **Last analyzed:** Mon Dec 22 2025 11:56:59 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** clinical-trials, qms
- **Specialties:** hematology, pathology, general-hospital, other
- **Device panels:** general_surgery, other
- **Regulatory pathways:** post_market
---
Key Highlights
- With over 10 years of specialized experience in the pharmaceutical and biologics sectors, Muhammad Saleem offers medtech companies profound expertise in Quality Assurance for complex and highly regulated products. His deep knowledge of GMP compliance, sterile manufacturing, and risk management (FMEA/RCA) is critical for organizations developing combination products, cell & gene therapies, or sterile medical devices. Having led quality programs and managed successful FDA/EMA interactions at major
- Muhammad Saleem's unique value is his specialized expertise at the intersection of pharmaceutical GMP standards and medical device quality systems. His background as a Doctor of Pharmacy, coupled with hands-on leadership in cutting-edge biologics and cell & gene therapy, provides medtech companies with a rare and powerful perspective for ensuring the quality and compliance of their most complex combination products.
Certifications & Trust Signals
- 10 years experience
Buyer Snapshot
Best for
- The ideal project for Muhammad Saleem involves a small-to-large medtech company or academic institution developing a combination product or a sterile medical device requiring rigorous quality oversight. He is a perfect fit for clients needing to establish a new QMS, achieve ISO 13485 compliance, or prepare for an FDA or EMA inspection. Companies facing challenges with post-market compliance, CAPA
HQ:
United States
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) RTA Remediation / Refuse-to-Accept Fix
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Years Experience:
10
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
general_surgery, other
Technology Types:
combo_product
Accepting New Clients:
Yes
