By Mike Levitt, Quality Executive Partners
In an article from Outsourced Pharma published April 24, 2023, Chief Editor Louis Garguilo stated his hypothesis that in the biopharma world, “Consultants have become more important than ever.” For many companies post-pandemic, staffing has been a challenge and, with speed to filing or manufacturing scale-up critical to success, finding critical skills to stay on schedule is a priority.
Once it is clear that some help is needed, the next question is: what type of assistance do I need? In today’s consulting marketplace, there are numerous firms and individuals who consider themselves “consultants” but, in fact, there are different types of consulting services, and determining which will serve you best is an important decision before you seek support.
I believe you can define six different types of consultants; all provide value if what they bring is, in fact, the service you need to achieve your business goals. In many cases you may need a mix of skills, but understanding what you are getting will increase the likelihood of a successful engagement.
The general definition of an auditor is someone who will review and verify the accuracy of data or compliance with regulations. They can help identify gaps in your processes or quality systems or confirm the completeness or accuracy of your data. The auditor will provide a report that identifies the issues and may offer potential solutions but, in most cases, will not or cannot facilitate the needed changes or improvements.
As reported in numerous articles, the pandemic resulted in a significant loss of experienced, knowledgeable expertise in many of the technical areas of pharmaceutical and biopharmaceutical development and manufacturing. A consultant with the requisite expertise and experience, the subject matter expert, can evaluate your issue and provide solutions that can provide a resolution, whether it is technical- or compliance-related. Often, these folks are recognized industrywide and may have numerous publications to their name. The implementation of the solution will usually be left to other resources.
These consultants are usually hired to address what is perceived to be a short-term staffing need. They are people who have performed the tasks required during their career and are providing additional resources to complete tasks that are usually performed by internal staff. Examples may include writing deviations, reviewing batch records, or filling other staff roles. Their efforts can help reduce backlogs of documents, but their contribution is usually transitory in that when they depart, if the issues generating the documents persist or the staffing required to manage internally isn’t in place, the problem will reoccur.
Like the expert, the trainer delivers a focused program designed to provide information on a particular topic. This can be delivered to groups in-house or provided remotely via the internet or at remote locations. Based on their experience, trainers can bring valuable knowledge to the people attending. Dozens of programs are advertised regularly covering virtually any topic in our industry. The impact can be significant but limited in that without reinforcement or a formal knowledge management effort in the company, only those in attendance may benefit and the knowledge can be quickly lost as people change positions.
A subset of the previous four consulting types is the coach/mentor. These consultants may bring expertise and a “doer” attitude, but they come with a focus on transferring their knowledge or capability to resources internal to the company. This has the benefit of raising the skill levels in the organization and driving change that will be sustainable after the engagement is complete.
Often, in highly technical industries such as ours this skill is not well understood, appreciated, or sought out. Not all consultants bring this capability to an engagement, so selecting the right consultants or firm that brings this skill is critical if sustainability is a goal.
The Interim Manager
The last type of consultant is really a subset of the coach/mentor. In this case a firm may contract with a firm or individual to provide a coach/mentor, who assumes, on a temporary basis, a position with active leadership/management responsibilities (e.g., operations or quality head, QA manager, laboratory manager). This type of engagement can be a bridge until a permanent resource is hired or serve to identify and train an internal candidate.
What Do I Need?
Understanding that there are different types of consultants raises two challenges. First, how do I determine what I need? Some leaders would say that the decision is simple: If I have a task to complete or a problem to resolve, my needs are temporary and can be resolved with the expert or the doer. If the issue isn’t clear, then the use of an auditor may provide the solution. The reality, however, is more complex. The auditor may define the problem or issue but often cannot provide an optimal solution. The expert or doer may solve or resolve the issue but may not address the root cause to prevent a recurrence and may not be present to defend the solution during a future inspection or submission. Often, organizations think that training will resolve the issue, but training, for the most part, is too general to address the specific cultural or skill deficits that led to the situation they are trying to address.
To determine what consulting support an organization needs requires leadership to ask itself the tough questions. Do I really understand the issue or problem? What is the business goal I am looking to achieve? Can I achieve my goals with help to define the problem or do I need help with implementing the solution? Are my needs short term (e.g., complete a submission or become inspection-ready) or do I need to build a sustainable solution that will meet my ongoing goals? The answers to these questions can then allow the firm to define the types of consultants they require.
How Can I Ensure I Get What I Need?
Once an organization has determined it needs consulting help, finding the best resources is the second significant challenge. As described above, identifying auditors, experts, and even doers by reviewing resumes and publications can seem straightforward. But the reality is that paperwork cannot reflect their judgement, ability to communicate, and capability to deliver timely and cost-effective results. A myriad of training courses promise great information, but we should all remember that the key is a good instructor. The toughest roles to fill are the coach/mentor and interim manager as these roles require not only strong technical skills but the management and interpersonal skills to lead and transfer knowledge.
Unfortunately, in today’s economic climate the selection process is often controlled by the finance group, but what are the cost savings if a consulting engagement fails to achieve the desired business goals? But unlike financial investing, which is always proclaiming “past performance is not necessarily an indicator of future results,” in consulting, past performance is a clear indicator of future results. Our industry is relatively small, so if you have not had direct experience with a particular consultant or consulting firm, seek out someone you trust to get feedback or ask the consultant/firm to provide references that you can contact. Interview the candidates to get a clear picture of how they will meet your deliverables and timeline.
Using consultants to successfully achieve your business goals is dependent on clearly identifying your needs, defining the right type of consultants or firm, and selecting your consulting partner based on demonstrated performance. The bottom line is that all consultants/firms are not the same, so choose wisely.
About The Author:
Mike Levitt is the vice president of strategic operations for Quality Executive Partners (QxP). He is a veteran operations senior executive with more than 40 years in the pharma industry working at Eli Lilly, Solvay, and entrepreneurial biotech companies. At QxP, Levitt leads project teams, supporting clients with new product approvals, quality systems remediation, and operational improvements. In addition, he specializes in regulatory inspection preparedness education and assists clients in responding to enforcement actions. He graduated from the University of Buffalo School of Pharmacy.