Meet Your Neighbor: CoverMyMeds’ Quality Management Team

For people in the corporate world, “quality management” may be a familiar phrase, but what does it mean?

Turns out, its exact definition evades even Merriam-Webster. But according to Investopedia, quality management is the act of overseeing all tasks that must be accomplished to maintain a desired level of excellence, including the determination of a quality policy, creating and implementing quality planning and assurance, and quality control and improvement.

We know, we know — that’s a lot of fancy-sounding words to wade through.

That said, the work CoverMyMeds’ quality management team does is crucial to our success as a company helping people get the medicine they need to live healthier lives. To break down the jargon and get a better understanding of who exactly our quality management team is, we sat down with three key people for a chat:

• Susanne McKenzie, manager, quality management
• Taylor Thomas, analyst, quality management
• Sheheryar Ahmad, analyst, quality management

Together, Susanne, Taylor and Sheheryar make up our quality management team in Columbus. A small-but-mighty bunch with counterparts in Scottsdale, Ariz., they’re responsible for ensuring CoverMyMeds always dots its Is and crosses its Ts when it comes to meeting and exceeding client expectations, regulatory requirements and more.

And, as you’ll discover, a couple of them are also enthusiastic about food. Now that’s something we can all understand.

What does our quality management team do?

Audits

Our quality management team supports three types of audits: regulatory, customer and internal. Audits are performed to ensure compliance with federal guidelines and contractual, financial and/or pharmacovigilance standards.

Quality Events

A “quality event,” or QE, can be many things (Editor: more on that soon), and they’re opened, investigated and documented by our quality management team to show clearly what immediate actions were taken to fix and prevent any further issues from occurring.

Process Improvements

Part of the quality management team’s mindset is to constantly look for ways to improve our company’s processes, systems and documents. If and when improvement opportunities are discovered, they work to address it.

How long have you been at CoverMyMeds and how’d you get the job?

Susanne: I joined CoverMyMeds in February of 2022. For the bulk of my career, I’ve worked for pharmaceutical manufacturers carrying out audits and compliance work. CoverMyMeds’ quality management team helps conduct client audits and regulatory inspections to reduce quality events (QEs) or potential adverse events (PAEs). We also help put formal processes and documentation in place.

Taylor: I started on Nov. 1, 2021, and I was the first employee on our quality management team in Columbus. Previously, I worked as a phlebotomist — someone who does your IV or draws blood — for a plasma donation company. In that role, I slowly worked my way up until I was the quality manager for my region. Then I moved to CoverMyMeds.

Sheheryar: I’ve been a quality analyst since April of 2022. I was previously the shared services project lead, responsible for PAE reporting and reconciliation as it relates to CoverMyMeds’ AMP: Access for More Patients program. We recently discovered PAE stuff fits better with the quality management team versus quality assurance team, so my current position evolved from that realization.

Wait, what’s a...

Quality event: A quality event, or QE, is an event in which a customer, regulatory or internal procedural requirement is not met or from which the requirement is deviated.

Potential adverse event: A potential adverse event, or PAE, is any undesirable experience — such as a headache — that’s associated with the use of a medical product in a patient.

All QEs and PAEs must be documented, reported and, if applicable, addressed through corrective actions.

Give me a glimpse of your typical 9-to-5. What does it look like?

Susanne: I spend many of my days in meetings, working with folks throughout the company who identify PAEs. I also work on active client audits, which require collaboration with our analytics, billing and sales teams to gather data and information to satisfy requirements. Since the quality management team is new to Columbus, I spend a lot of time educating and training employees on how to take advantage of our team’s expertise.

Taylor: Since we work closely with our counterparts in Scottsdale, my 9-to-5 is actually a 7-to-3. A typical, no-surprise day means lots of emails. I go through my inbox, address challenges from the day before, and then start reviewing open quality events. I also keep track of our quality event training — I’m the training captain, so to speak. I check the status of ongoing and upcoming audits, set up one-on-one meetings with account and operations managers to make sure they're prepared and address any outstanding observations.

Sheheryar: My daily job is unique because I’m still transitioning from my previous role as a shared services project lead, ensuring PAEs are reported appropriately and on time to manufacturers. I also provide support with PAE questions that arise related to AMP, assisting with reconciliations. With my analyst work, I help with quality event documentation. I primarily work on investigating and reviewing PAEs and developing a course of action to reach a resolution.