Thinking About the High Performers

I am blessed to have inherited a lot of high performers from my predecessor, who built and sustained a highly functioning team, often amid chaos.

I think about what that means to my team a lot. Being a bunch of high performers, they tend to get:

  • Stressful projects and goalsThey often receive a lot of complex and risky projects and goals.
  • Meeting mania: Because my team is viewed as an essential part of the work (and they are) and can solve even the thorniest issues, their days are filled with back-to-back meetings.
  • Return-to-office pressure: Because they are “high profile,” my local team members are expected to work more from the plant, resulting in less flexibility. There are many good reasons for this, but that doesn’t make it more popular.

As I move through my 2nd quarter, here are the activities I am working to implement.

Establish a simple weekly team rhythm that drives intensity, not pressure. This is going to take a lot of effort with my peer teams. We need to build a rhythm where we know (to a much higher detail) the types of work we do. I want to move more to a model where we do prioritization on Monday, including defining projects, managing change controls, etc.; problem-solving midweek and a time we do a lot of execution (though frankly, that also happens on the weekend); and Friday is to review completed work, share feedback, and align on next steps. No matter what, we need to create a standardized calendar.

Measure the team’s motivation. As I get close to my 5-month mark, I will be asking the following questions:

  • What are teammates excited about working on in the second half of the year?
  • What might be causing them anxiety or pressure?
  • What habits does the team want to improve?
  • What are some specific ideas for improving those habits?
  • What did we do really well last quarter that we should maintain?

Continue to prioritize teaching. I will be scheduling a quarterly skill-check meeting with each of the team. During this conversation, I will help the individual reflect on their current skill goals and pick a new one if they don’t yet have any or have hit them all. We put a lot of work into this during my first quarter, and it is critical to continue to grow here.

Practice Joy. Practicing joy at work is important to maintaining a positive work environment and improving overall job satisfaction.

  1. Cultivate gratitude: Start each day by acknowledging something you’re grateful for at work.
  2. Celebrate small wins: Recognize and appreciate your accomplishments, no matter how small. This can boost your motivation and create a sense of progress.
  3. Find purpose in your work: Connect your daily tasks to the larger goals of your organization or to your personal values. Understanding how your work contributes to a greater purpose can increase job satisfaction.
  4. Find humor in daily situations: Look for opportunities to laugh and share light moments with your colleagues. Humor can help reduce stress and create a more positive work environment.
  5. Practice self-care: Prioritize your physical and mental health by getting enough sleep, eating well, and exercising regularly. When you feel good, it’s easier to experience joy at work.
Photo by Belle Co on Pexels.com

Fostering Critical Thinking

As a leader, fostering critical thinking in my team and beyond is a core part of my job. Fostering critical thinking means an approach that encourages open-mindedness, curiosity, and structured problem-solving.

Encourage Questioning and Healthy Debate

It is essential to create an environment where team members feel comfortable questioning assumptions and engaging in constructive debates. Encourage them to ask “why” and explore different perspectives. This open dialogue promotes deeper thinking and prevents groupthink.

Foster a Culture of Curiosity

Inspire your team to ask questions and seek deeper understanding. Role model this behavior by starting meetings with thought-provoking “what if” scenarios or sharing your own curiosities. Celebrate curiosity and reward those who think outside the box.

Assign Stretch Assignments

Provide your team with challenging tasks that push them beyond their comfort zones. These stretch assignments force them to think critically, analyze information from multiple angles, and develop innovative solutions.

Promote Diverse Perspectives

Encourage diversity of thought within your team. Diverse backgrounds, experiences, and viewpoints can challenge assumptions and biases, leading to a more comprehensive understanding and better decision-making.

Engage in Collaborative Problem-Solving

Involve your team in decision-making processes and problem-solving exercises. Techniques like role reversal debates, where team members argue a point they disagree with, can help them understand different perspectives and refine their argumentative skills.

Provide Training and Resources

Offer training sessions on critical thinking techniques, such as SWOT analysis, root cause analysis, and logical fallacies. Equip your team with the tools and frameworks they need to think critically.

Lead by Example

As a leader, model critical thinking behaviors. Discuss your thought processes openly, question your assumptions, and show the value of critical evaluation in real-time decision-making. Your team will be more likely to emulate these habits.

Encourage Continuous Learning

Recommend learning resources, such as courses, articles, and books from diverse fields. Continuous learning can broaden perspectives and foster multifaceted thinking.

Embrace Feedback and Mistakes

Establish feedback loops within the team and create a safe environment where mistakes are treated as learning opportunities. Receiving and giving feedback helps refine understanding and overcome biases.

Implement Role-Playing Scenarios

Use role-playing scenarios to simulate real-world challenges. This helps team members practice critical thinking in a controlled environment, enhancing their ability to apply these skills in actual situations.

Build Into the Team Charter

Building these expectations into the team charter holds you and your team accountable.

Value: Regulatory Intelligence

Definition: Stay current on industry regulations and guidances. 

Desired Behaviors:

  1. I will dedicate time to reading industry-related guidance and regulation publications related to my job.
  2. I will share publications that I find interesting or applicable to my job with the team
  3. I will present to the team on at least one topic per year to share learnings with the team (or wider organization)

Value: Learning Culture

Definition: Share lessons learned from projects so the team can grow together and remain aligned.  Engage in knowledge-sharing sessions.

Desired Behaviors:

  1. I will share lessons learned from each project with the wider team via the team channel and/or weekly team meeting.
  2. I will encourage team members to openly share their experiences, successes, and challenges without fear of judgement.
  3. I will update RAID log with decisions made by the team.
  4. I will identify possible process improvements and update the process improvement tracker.

Value: Team Collaboration

Definition: Willingness to help teammates when they reach out for input/help

Desired Behaviors:

  1. I will be supportive of my teammate’s requests for assistance
  2. I will engage and offer my SME advice when asked or help identify another SME to assist 
  3. I will not ignore requests for input/help
  4. I will contribute to an environment where teammates can request help

Where I am at

I recently joined Just Evotec Biologics as the Senior Director of Global Quality Engineering and Validation. For a variety of reasons (just look at my past company on my LinkedIn bio and search the news to find one) it was a good time to move. I had decided that I wanted a position that was tied to an innovative manufacturing company and was deep in domain expertise. The combination of Just Evotec Biologics innovative technology aims and the ability to deep dive into one of my favorite topics was just too much to resist. Add to it the opportunity to work with a leader I deeply respected again and well, here I am. And feeling very good about it.

When I first started I met with the team and laid out my 30-60-90 day goals.

As well as talking a little about how I operate.

A big chunk of my time has been getting the lay-of-the-land institutionally. Setting some standards, doing gap assessments, figuring out what-is-what, and getting to know all my partners and stakeholders. For reasons of confidentiality, this post won’t be going deep on that.

What I do want to talk about is our team values and ways of working. I’ve been focused heavily on three areas with the team:

  1. Team Values
  2. Team Decision Making
  3. Team Competencies

Team Values

We did a few workshops where we identified a set of values:

  1. Leader to Team: How I expect the team to perform
  2. Team to Leader: How the Team expects me to perform
  3. Team to Team: How we expect each other to perform

This exercise really helped me understand what was going on within the team and through it I really started to understand some priorities.

For each of these, we created a Value Statement. Here are some examples.

Value: United Front

Definition: Decisions are made and recorded honestly and transparently. Employees understand decisions and how to execute them. The entire team represents the decisions made, and the decision-making process with one voice. 

Desired Behaviors:

  1. I hold myself accountable for representing the decisions made by the team.
  2. I work to anticipate and fend off the possibility of failures occurring.
  3. I engage with decision making and respect the decisions that result.

Value: Open to Change

Definition: Willingness to listen to the team.  Actively looking for feedback and input from the team before making decisions that impact the team.  Open to changing established ways and revisiting previously made decisions.  

Desired Behaviors:

  1. I will be transparent with decision-making.
  2. I will create an environment where new ideas are welcome and challenging ideas are encouraged.
  3. I will include the team in decision-making where applicable.
  4. I will actively seek out individual and group feedback to enable continuous improvements.

Value: Learning Culture

Definition: Share lessons learned from projects so team can grow together and remain aligned.  Engage in knowledge-sharing sessions.

Desired Behaviors:

  1. I will share lessons learned from each project with the wider QEV team via teams channel &/or weekly team meetings.
  2. I will encourage team members to openly share their experiences, successes, and challenges without fear of judgement.
  3. I will update RAID log with decisions made by the team.
  4. I will identify possible process improvements and update the process improvement tracker 

Team Decision Making

Currently working with the team to define decision-making, introducing the RAPID model and working on a matrix of decisions.

Team Competencies

Starting with technical skills we are defining our core competencies. Next, we will tackle, with the larger quality organization, the soft skill side of the equation. This is definitely a work in progress.

Skill Area

Key Aspects

Proficiency Levels

 

Beginner

Intermediate

Advanced

Expert

General CQV Principles

       Modern process validation and guidance 

       Validation design and how to reduce variability

       Able to review a basic protocol

       Able to review/approve Validation document deliverables.

       Understands the importance of a well-defined URS.

       Able to be QEV lead in a small project

       Able to answer questions and guide others in QEV

       Participates in process improvement

       Able to review and approve RTM/SRs

       Able to be QEV lead in a large project project

       Trains and mentors others in QEV

       Leads process improvement initiatives

       Able to provide Quality oversight on the creation of Validation Plans for complex systems and/or projects

       Sets overall CQV strategy

       Recognized as an expert outside of JEB

Facilities and Utilities

       Oversee Facilities, HVAC and Controlled Environments

       Pharma Water and WFI

       Pure Steam, Compressed Air, Medical Gases

       Understands the principles and GMP requirements

       Applies the principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility fitness-for-use/qualification

       Guide the Design to Qualification Process for new facilities/utilities or the expansion of existing facilities/utilities

       Able to establish best practices

Systems and Equipment

       Equipment, including Lab equipment

       Understands the principles and GMP requirements

       Principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating equipment fitness-for-use/qualification

       Able to provide overall strategy for large projects

       Able to be QEV lead on complex systems and equipment.

       Able to establish best practices

Computer Systems and Data Integrity

       Computer lifecycle, including validation

       Understands the principles and GMP requirements

       Able to review CSV documents

       Apply GAMP5 risk based approach

       Day-to-day quality oversight

       Able to provide overall strategy for a risk based GAMP5 approach to computer system quality

       Able to establish best practices

Asset Lifecycle

       Quality oversight and decision making in the lifecycle asset lifecycle: Plan, acquire, use, maintain, and dispose of assets 

       Can use CMMS to look up Calibrations, Cal schedules and PM schedules

       Quality oversight of asset lifecycle decisions

       Able to provide oversight on Cal/PM frequency

       Able to assess impact to validated state for corrective WO’s.

       Able to establish asset lifecycle for new equipment classes

       Establish risk-based PM for new asset classes

       Establish asset lifecycle approach

Quality Systems

       SOP/WI and other GxP Documents

       Deviation

       Change Control

       Able to use the eQMS

       Deviation reviewer (minor/major)

       Change Control approver

       Document author/approver

       Deviation reviewer (critical)

       Manage umbrella/Parent changes

       Able to set strategic direction

Cleaning, Sanitization and Sterilization Validation

       Evaluate and execute cleaning practices, limit calculations, scientific rationales, and validation documents 

       Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state

       Differentiate the requirements for cleaning and sterilization validation when using manual, semi-automatic, and automatic cleaning technologies

       Review protocols

       Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents

       Understand Sterilization principles and requirements 

       Create, review and approve scientifically sound rationales, validation protocols, and reports

       Manage and remediate the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products

       Define cleaning/sterilization validation strategy to meet GMP requirements

Quality Risk Management

       Apply QRM principles according to Q9

       Participate in a risk assessment

       Determine appropriate tools

       Establish risk-based decision-making tools

       Set risk-based approaches

       Define risk management program for CQV activities

 

I’d love feedback on this.

My Overall Philosophy

I’ve been focusing on five key tasks as a leader in this organization:

  1. How I build and gain agreement
  2. Grow the Team
  3. Results and Learning
  4. Deliberate Presence
  5. Prioritizing the Right Relationship

Still a lot to do but I am having a blast.