Hiring the right Quality consultant can be a great benefit to your company. Learn how to choose a professional that fits your needs and saves you time and money!
While hiring a Quality consultant isn’t dramatically different from other hirings, there are a few things that will help ensure your success.
What Does a Quality Consultant do?
A Quality consultant helps pharmaceutical, medical device and biotech life science companies throughout all stages of clinical trials, product development, and commercial manufacturing, providing guidance on GCP, GMP, GVP, and GLP.
Quality consultants assist with:
- GxP regulatory compliance
- Clinical trials
- QMS system design, improvement and review
- Pharmacovigilance
- Product release
- Gap analysis
- Risk assessment
- Regulatory agency inspections (readiness, management, findings and responses)
- Corrective and Preventive Action (CAPA) plan design and implementation
- Due diligence
- Interim GxP Quality leadership
“How do I Hire the Right Consultant?”
These five tips will help you make sure you hire the right consultant.
1. Identify your wants and needs
When you hire a Quality consultant, you should spend some time defining what work needs to be done, the skills needed to complete it, deliverables, and the project timeline. This will help you when looking at resumes, during interviews, when creating the contract/statement of work, and when managing the project.
2. Assess the consultant’s expertise and experience
When looking at resumes, assess whether the consultants have the necessary skills and experience to complete the project successfully in the allotted time.
Some things to consider:
- Does the consultant have the necessary GxP experience?
- Does the consultant have experience with pharmaceutical/medical device/combination products?
- What is the consultant’s regulatory inspection experience? Has the consultant worked with FDA, EMA, MHRA, CDSCO, Health Canada, MHLW, SWISSMEDIC, or other regulatory agencies relevant to your company?
- What experience does the consultant have designing and implementing compliant quality systems?
- What phases of clinical trials has the consultant worked on?
- Has the consultant worked with small companies that haven’t brought a product to market?
- What is the consultant’s experience with large companies with multiple products on the market?
- Does the consultant have experience transitioning from development to commercial?
3. Be open during the interview
When you interview a potential consultant, be clear about the work you want performed, time objectives, and the result(s) you want.
Don’t withhold information from the consultant. He/she is there to help you be successful, and the more information you provide, the better the consultant will be able to leverage his/her expertise to achieve your desired outcome on time or sooner.
4. Look for Someone who Will Work With You
When selecting a consultant, you’re looking for a person who will help you and your company meet your goals. You are looking for a person who doesn’t work for you, needing to be micro-managed each step of the way. The right consultant will be independent, self-motivated, and focused on your needs. The right consultant will be a partner working with you to ensure your success.
5. Focus on today while planning for the future
During the time you work with a Quality consultant, the consultant gets to know your company, your team, and your product(s)/pipeline. This knowledge can be beneficial in the future as the consultant can come on board for other projects more quickly. Thus, when choosing a consultant, also consider whether he/she could also be an asset for you in the future, saving you time and money both in hiring and in project completion.
Hiring the right Quality consultant presents a few challenges, but hopefully these simple tips will help make your next hire a success! And…
Now that you know how to hire the right contractor, it may just be time to check out our services if you haven’t already.