Jennifer Vavala is Executive Director, Quality and Compliance at PCI Pharma Services, a leading contract development and manufacturing organization (CDMO) providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success.
Career Foundation in Microbiology Shapes Leadership
My career began as a microbiologist at a contract test laboratory (CTL), an experience that has strongly influenced each step of my career. Being responsible for hundreds of products, product types, and specifications at the very outset of my career set the stage for the scope and scale of projects I’ve helped lead over the years.
For a CTL, data is the product and integrity is crucial. Having that type of cGMP exposure early on was a blessing that continues to inform my compliance mindset. Notably, my background in microbiology has enhanced my ability to oversee quality systems and contamination control strategies for drug product manufacturing.
All of this translates exceptionally well to my new role with PCI Pharma Services, where I have ample opportunities to apply these tried and true principles at a leading sterile-fill finish CDMO.
Building Culture through Empowerment and Training
It is important to remember that one person cannot do it all. An organization’s culture of compliance and operational excellence must be top-down and bottom-up, with knowledge management, crisp and consistent communication, and succession planning all critical and a diverse team of professional talent with varying areas of expertise essential.
“A committed group of professionals with autonomy is the safest bet for success”
Wherever possible, I find that it’s best to strive for decision-making at the most junior level, which simultaneously empowers personnel while growing their skill sets. It’s also valuable to encourage internal and external training opportunities, both for individuals and teams. Amidst an ever-evolving regulatory landscape, staying up to date typically means spreading knowledge responsibilities around. A committed group of trusted professionals, with the autonomy and authority to solve problems, is the safest bet for success in a sector where the quality and compliance stakes cannot be higher.
Aligning Compliance with Growth through Risk Management
The rapidly-growing biopharma space certainly presents challenges – but they are what I’d call “good problems.” And always, solving those problems starts with the mindset that compliance and quality are non-negotiable, no matter the specific product attributes or business strategy driving an individual therapy.
Compliance is expected whether an organization develops just a single product or mass manufactures scores of them. Each product’s quality and compliance initiative must be carefully customized, and addressed with the right combination of technology, automation and, of course, human expertise. As evidenced by its sterling track record, PCI Pharma Services is unwavering in its quality and compliance commitments, regardless of a product’s scope or scale. These principles permeate the San Diego campus where I’m based, as well as the global organization as a whole.
Each departure from an established cGMP standard or controlled document starts as a QI and, from there, quality assurance personnel commence a risk-based assessment whose result is one of three paths: investigation, correction, or closure. This tight, “if this, then that” approach helps us spend time more wisely on issues that truly require root cause analysis and corrective actions and prevents us from overburdening the QMS with investigations into minor matters.
Two other initiatives are site-specific documents associated with Risk Management Principles for Aseptic Processing and Adverse Trending Rubric. While these are unrelated in title, each entails enhanced risk management principles.
Risk Management Principles for Aseptic Processing ensure that all risk contribution factors inherent to aseptic processing are accurately represented and weighted in a quantitative assessment. The Adverse Trending Rubric establishes a threshold frequency and criteria for defining an adverse trend when conducting the historical review portion of investigations. This helps remove subjectivity when completing this portion of the record, streamlining and guard-railing the overall process.
Strengthening compliance via risk-based initiatives
As previously mentioned, Knowledge Management (KM) is a key tool for staying agile, proactive and futurefocused while mitigating risk. Proper KM allows organizations to understand where risk is most prevalent, shows proof that existing controls are adequate, and has inputs for predictive modeling to facilitate process improvements. As the regulatory landscape continues to become more complex, having documented evidence of the current state helps shape the future and allows for troubleshooting into any current or near future challenges.
