top of page

Services Offered

Laboratory

With my extensive background in quality operations, spanning from research and GMP commercial manufacturing to all clinical stages, including pre-clinical, I can easily identify areas for improvement, which is particularly valuable in auditing.


Similarly, my experience has shown that emerging biotech organizations often struggle with managing-party vendors and tend to delay investing the time and energy needed to build a QMS until it becomes very complicated and/or disjointed to remediate effectively.

My current services include:

  • Auditing: Leveraging past work experience to audit potential vendors or requalify existing ones.

  • Vendor Management: Revamping your existing third-party management program or building a new one.

  • QMS Support: Providing general quality support that ranges from handling day-to-day activities to building your QA unit.


To give you a clearer picture of the problems I can solve, I have outlined some of the most common issues related to these critical quality processes.

Lab Work

Common problems w/ Vendor Mgt

  • No proper vendor selection criteria

  • Inadequate (or lack thereof!) vendor risk assessments - How to you determine requalification requirements?

  • Decentralized or incomplete vendor related records - Do you have an up-to-date inventory of all vendors, including vendor risk rating, and requalification & audit dates?

  • Lack of vendor oversight - Is it clear in your organization who are vendor owners, responsible to build rapport, communication, and oversight?  

  • Lack of understanding from staff on the actual process due to an overly complex and not fit-for-purpose vendor qualification program 

  • No quality metrics collected to monitor vendor performance and identify trends

  • Changes to vendors not being properly documented. Any relevant change should be document via a change control process 

Business Meeting

Common Problems w/ Auditing

  • No proper Audit Schedule - you're on firefighting mode trying to keep up with requirements. Are your audits overdue or about to go overdue?

  • Inadequate audit scope. There is no clear distinction between initial vendor qualification audits vs routine audits. Does your current process clearly distinguish the multiple types of audits and scope that may be applicable to your operations?

  • ​Lack of proper follow up to ensure audit related CAPAs have addressed the issues! Audits NEVER end with the report...

  • Lack of proper training for auditors - are you depending on your internal staff to conduct all audits? Are they properly trained to serve as auditors?​

  • Lengthy times to complete reports and CAPAs

  • Poor QA oversight and lack of metrics​ - ideally you should have a live dashboard showing upcoming audits, overdue CAPAs, and any other relevant metric

Reviewing Reports at Desk
Computer with Graph

Common Problems w/
QMS Implementation

  • QA brought to the table too late! If there are GxP operations, QA representation should have been there already...

  • Lack of a formal QA organization

  • Lack of a proper quality culture. Do you have a formal quality policy in place?

  • Lack of a proper GxP training program. Are you able to provide evidence your staff is qualified to do the job they do?

  • Senior Mgt disengaged or feels that quality is not a priority at early stages

  • No formal Management Review or Quality Council implemented

  • No Annual Review of the QMS - do you keep a live quality dashboard monitoring your QMS health? 

  • No formal Change Review Board in place - how do you record the impact of changes across your multiple line functions?

bottom of page