"My Job" is an occasional item that describes a pharma-manufacturing position from the first-person perspective of someone newly appointed to the position, whether through promotion or as a new hire. The intent is to provide over time a picture of positions in the pharma industry, in hopes that the picture will be useful in career planning. - George Miller
Compliance Implementation Services, located outside Philadelphia, recently announced that Venessa Piper-Givler had joined the consultancy as director for manufacturing compliance. Over a 20-year career, she has worked in quality-control and -assurance positions, some at the executive level, as well as compliance positions. Here she shares her going-in thoughts on the new job.
FiercePharmaManufacturing: Your job title includes both "manufacturing" and "compliance." Which is the driver?
Piper-Givler: Compliance, because manufacturing sites in the Philadelphia area are inspected often by many agencies. So compliance must be ensured if product is to be manufactured.
Also, the regulations are always evolving, so quality departments need to ensure that the manufacturing sites are complying and are in an inspection-ready state.
What do you love about your work?
It's always changing and I never encounter the same day twice. Pennsylvania is a challenging state to work in. My job allows the development of many skills and my days are certainly never boring.
What's the main difference between manufacturing compliance for a contract manufacturer versus a drug company?
Contract manufacturers always need to be compliant with different regulations all over the world. Also, contract manufacturers need to be compliant with all of their customer requests--very complex for a manufacturing site to organize and manage. In addition, contract manufacturers deal with numerous customer audits throughout the year, adding another level of complexity.
In a typical week, what percentage of your time is spent on the following?
- Working alone (research, admin, etc): 15%
- Working with company colleagues: 25%
- Working with customers: 50%
- Working with regulators: 10%
How many people do you oversee?
Currently at CIS we are growing the Manufacturing Compliance Services area. I now oversee five people. As a Director of Quality in the industry, I had as many as 45 people in my department.
What will be different about CIS after you've been on the job for a year?
We'll have a strong manufacturing compliance team, comprising folks from the industry with backgrounds in API, final dosage, biologics and sterile manufacturing, providing customers with expertise to improve their quality systems.