In the most recent episode of our podcast, The Life Science Rundown, The FDA Group's Nick Capman sat down with Aaron Snyder, the Vice President of Quality Assurance at Allotex, an ophthalmic biologics and device startup developing therapies for presbyopia, hyperopia, and myopia, to explore the critical elements of building and leading a successful quality assurance team in the life sciences industry. Aaron brings over 20 years of experience in medical devices and pharmaceuticals, specializing in quality systems and team dynamics.
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Summary, Key Points, and Practical Takeaways
I. Recognizing the Need for Change
Aaron emphasizes that companies often reach a tipping point where they must transition from a small QA team to a larger, more structured team to support business growth. Recognizing this need early and preparing for the transition is crucial for maintaining quality and compliance. He shares examples from his experience where recognizing early signs of strain in the quality system prompted timely interventions that prevented more significant issues.
At the Waters Corporation, Aaron noticed that the existing quality system and team were not equipped to support the company's planned expansion into the in-vitro diagnostics business. He saw an increasing backlog in quality reviews, delayed product releases, and frequent compliance issues. By recognizing these early indicators, Aaron advocated for and successfully built out the quality team and system, which helped the company achieve its growth objectives without compromising quality.
A few recommended action items include:
Regularly review key metrics like backlog in quality reviews, frequency of compliance issues, and delays in product releases to identify early signs of strain.
Conduct a detailed gap analysis to pinpoint specific areas where the current quality system is falling short and quantify the impact on business operations.
Make sure you’re scheduling regular meetings with key stakeholders to discuss quality system performance and identify emerging needs.
II. The Interview Process
Aaron highlights the importance of thoroughly vetting potential employers during the interview process. He advises candidates to ask direct questions about management styles, conflict resolution, and organizational support to ensure alignment with their own values and expectations. Practical questions include: "How do you handle conflict?" and "How do you communicate challenges and bad news?" Understanding how a manager handles conflict and communicates challenges is vital for determining if the role will be a good fit. Aaron also suggests observing the dynamics and asking about specific scenarios to gauge the company's culture and the manager's leadership style.
During his interview at Fresenius Kabi, Aaron focused on understanding how his potential manager dealt with conflict and communicated bad news. He asked questions like, "Can you give an example of a time when you had to handle a significant issue with a team member?" This helped him gauge whether the leadership style aligned with his own approach and values.
A few recommended action items include:
Prepare a set of behavioral questions to ask during the interview, such as, “Can you describe a time when you had to deliver bad news to your team? How did you handle it?”
Ask for examples of how the company has supported its QA team in the past during crises or significant changes.
Request a tour of the QA department to observe the team dynamics and work environment firsthand.
III. Managing the First 90 Days in a New Role
In the initial 90 days, Aaron suggests focusing on understanding the team dynamics, identifying major stakeholders, and learning the organization's goals. This means spending time with team members to understand their frustrations and aspirations and building relationships with key stakeholders. He suggests having one-on-one meetings with each team member and key stakeholders to gather insights. This “fact-finding” phase sets the foundation for developing a robust plan to drive improvements.
A few recommended action items include:
Within the first two weeks, schedule one-on-one meetings with each team member and key stakeholders to gather insights and build relationships.
Conduct listening sessions with the team to understand their frustrations and aspirations without interrupting or offering immediate solutions.
Create a simple stakeholder map to identify and understand each stakeholder's influence and interest in the quality system.
IV. Creating a Strategic Plan
Develop a strategic plan based on the insights gathered during the first 90 days. Aaron suggests using tools like Gantt charts to outline high-level tasks and timelines. Engage team members and stakeholders in refining the plan to ensure buy-in and alignment. He emphasizes the importance of documenting the plan and iterating on it with feedback from team members and stakeholders. Make sure to regularly communicate the plan’s progress and make adjustments as needed to stay on track. Aaron also mentions the value of creating an accountability chart to clarify roles and responsibilities within the team.
After his initial 90 days at Waters, for example, Aaron developed a strategic plan that included restructuring the quality team and implementing new processes to handle the increasing workload. He used Gantt charts to visualize the timeline for each initiative and held regular meetings with his team to gather feedback and make necessary adjustments.
A few recommended action items include:
Perform a SWOT analysis (Strengths, Weaknesses, Opportunities, Threats) to inform the strategic plan.
Develop an accountability chart to clearly define roles and responsibilities within the team.
Establish a feedback loop where team members can continuously provide input on the plan’s effectiveness and suggest improvements.
V. Effective Communication and Meeting Cadence
Aaron stresses the importance of establishing a structured meeting schedule to maintain momentum and accountability. He suggests a mix of daily, weekly, and monthly meetings tailored to the organization's needs. Overcommunicating progress, challenges, and goals help keep the team engaged and aligned. Delivering bad news with honesty and providing hope for improvement is crucial for maintaining morale. Aaron shares that in his experience, the right meeting cadence can help avoid ad-hoc emergency meetings, which can be disruptive and demoralizing.
At Fresenius Kabi, Aaron implemented a communication strategy that included daily stand-up meetings with his team, weekly review meetings with senior management, and monthly updates to the corporate QA team. This structured approach ensured that everyone was aware of progress and any issues that needed addressing, reducing the need for unexpected meetings.
A few recommended action items include:
Hold daily stand-up meetings to quickly address issues and align on daily goals.
Use a shared action items tracker during meetings to assign tasks, set deadlines, and follow up on progress.
Develop a framework for delivering bad news that includes providing context, addressing immediate concerns, and outlining steps for improvement.
VI. Building the Right Team
Assess the current team to ensure each member is in the right role. Aaron shares his experiences of having difficult but necessary conversations with employees who may not be well-suited for their current positions. Reallocating roles based on individuals' strengths can lead to better performance and job satisfaction. In cases where no suitable internal role exists, support employees in finding opportunities elsewhere. Aaron provides an example where he helped an employee transition to a role that better suited their skills, resulting in improved performance and satisfaction.
At Waters, for example, Aaron identified that one of his team members was struggling in their current role. After a candid conversation, he learned that the employee had strengths better suited to a different position within the organization. By facilitating this transition, the employee's performance and job satisfaction significantly improved.
A few recommended action items include:
Conduct a skills assessment to identify each team member’s strengths and areas for development.
Reassign roles based on the skills assessment to better align with team members' strengths and the team’s needs.
Create personalized career development plans for each team member to support their growth and job satisfaction.
VII. Making the Business Case for Team Expansion
When the need arises to expand the team, prepare a comprehensive business case outlining the current workload, gaps, and the impact of not hiring additional staff. Clearly define the new role and its responsibilities to ensure the right fit. Use metrics and workload analysis to justify the need for expansion to decision-makers. Aaron emphasizes the importance of presenting both the benefits of hiring and the potential risks of not hiring to provide a balanced view to decision-makers.
At Allotex, Aaron noticed that his team was struggling to keep up with the increasing workload. He prepared a detailed business case, showing the current and projected workload, the gaps in coverage, and the impact on quality and compliance if additional staff were not hired. This comprehensive analysis helped him secure approval for hiring more team members.
A few recommended action items include:
Collect and analyze data on the current workload, including the number of tasks, hours worked, and overtime trends.
Prepare a cost-benefit analysis showing the financial impact of hiring additional staff versus the risks and costs of not expanding the team.
Define success metrics for the new hire’s impact on the team and organization, such as reduced backlog or improved compliance rates.
VIII. Utilizing Contractors
Consider bringing in contractors to handle immediate workload increases while recruiting full-time staff. Contractors can provide valuable insights into refining job descriptions and identifying the skills needed for permanent roles. They can also assist in the onboarding and training process for new hires, ensuring a smoother transition. Aaron mentions that contractors can help validate job descriptions and assist in the interviewing process to ensure the right fit.
At Fresenius Kabi, Aaron brought in contractors to manage the surge in workload while recruiting permanent staff. The contractors helped identify gaps in the current processes and provided valuable feedback that refined the job descriptions for the new hires. This approach ensured a seamless transition once the full-time staff were onboarded.
A few recommended action items include:
Develop a streamlined onboarding process for contractors to quickly integrate them into the team.
Set clear performance metrics for contractors to ensure they meet the organization’s standards and expectations.
Implement a knowledge transfer process to capture the insights and best practices from contractors before their engagement ends.
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IX. Continuous Improvement and Adaptability
Aaron underscores the importance of continuous improvement in the quality system. Processes and metrics should be regularly updated to reflect organizational growth and changing priorities. Continuous learning and adaptation should be engaged to ensure the quality system remains effective and relevant. He highlights the need to align metrics with the company’s evolving goals and continuously assess and refine them based on feedback and performance data.
At Allotex, Aaron implemented a continuous improvement program involving regular quality system and metrics reviews. He encouraged his team to provide feedback on processes and used this input to make iterative improvements. This approach ensured that the quality system evolved with the company’s growth and changing priorities.
A few recommended action items include:
Organize regular Kaizen events focused on continuous improvement initiatives within the quality system.
Develop a real-time metrics dashboard to monitor key performance indicators and identify areas for improvement.
Hold regular feedback sessions with the team to discuss process improvements and implement suggestions.
X. Leveraging Experience and Young Talent
Combining experienced leadership with young talent fosters innovation and drives success. Aaron believes in creating a dynamic team environment where the wisdom of experienced professionals blends with the fresh perspectives of younger team members. He shares examples of how this combination has led to innovative solutions and a vibrant team culture.
At Allotex, Aaron built a team that included both seasoned professionals and young talent. This mix of experience and fresh ideas led to innovative solutions, such as new quality audits and risk management approaches, which significantly improved the team's performance and cohesion.
A few recommended action items include:
Establish a mentorship program pairing experienced professionals with younger team members to facilitate knowledge sharing and professional growth.
Conduct innovation workshops where team members can brainstorm and develop new ideas and solutions.
Create project teams with a mix of experienced and young talent to leverage diverse perspectives and skills.
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