How GxP Leaders Can Assess and Approach a Company’s Quality Culture

Katie H. Terry

The term “quality culture” was coined over a decade ago. The goal was to promote a quality-centric corporate culture with a particular emphasis on executive management’s role. Over time, the theory of a corporate culture shaped by compliance via high ethical and quality standards highlighted the impact on the firm’s brand, commitment to patients, and bottom line. The result has been simple: Quality culture shifted from industry jargon to a strategic imperative.

Given the importance of the compliance and quality culture, how can GxP—good manufacturing practices, good clinical practices, good laboratory practices, and good distribution practices—leaders seeking new roles in early stage companies assess a corporation’s culture through the interview process?

Compliance and quality-centric culture

Cynthia Ingols

We’ve all heard the saying “quality is everyone’s job.” However, compliance and quality across the firm have different meanings for different functions. Within GxP quality, five organizational components consistently surface when discussing how to achieve a quality culture: executive management’s commitment, individual responsibility, psychological safety, understanding employees’ mindset, and reward and recognition programs. Examples of a compliance and quality-centric culture include:

• Quality initiatives are embedded into corporate objectives.
• Employees work with the highest level of integrity and ethics.
• Quality risks are openly discussed at every level.
• It’s widely accepted that there is good intent promoting collaboration.
• There is a strong commitment to professional development and training across all organizational levels.

The trick for job-seeking GxP leaders is to discover where a company is on its compliance and quality culture journey. Here are some ways to begin that diagnosis.

Preparation is key

To construct a mutually beneficial discussion, do your homework—but with a twist. Concentrate interview preparatory efforts on executive team members and in-house scientists and pipeline products, and examine publications and conferences that reference the company.

Executive team members: When assessing the executive team, examine each team members’ career trajectory and the types of organizations in which they have worked (mature and large or startup and small). Ask if the leaders have experience building a brand and transitioning a novel therapeutic drug from the clinic to commercial success? Of equal importance, assess if the executives are complementary. For example, if the CEO has a strong scientific background, note if there is also an executive who has a strong commercial and marketing background.

In-house scientists and pipeline products: Top talent is often attracted to innovation resulting in a robust and compelling pipeline of medicines. Survey the therapeutic areas to understand the competitive landscape. If not on the interview panel, ask to speak with in-house scientists. Not only can they be a direct source of innovation, but they could be important allies in the future change for the firm as it advances commercial assets.

Examine publications and conferences: With cutting-edge science comes the opportunity to showcase data and scientific learning in various media formats. Examine recent publications and participation at industry conferences to gauge external presence and industry excitement about the company and its products. Ask if the publications are current, in reputable journals, and consistent with the company’s brand. These questions can also be applied to conferences.

Asking the right questions

Armed with your completed homework, you can structure a fruitful discussion by planning your desired learnings and how to ask thoughtful questions. Try asking the same question throughout the interview to see different pieces of the puzzle that you’re looking to understand. Consider the following approach should you have the opportunity to interview with an executive:

Accepting the job and getting started

This framework should encourage fresh ideas to assess an organization, its culture, and how a GxP leader might assimilate to an early stage company. To that end, it’s advised to begin the on-boarding process with three focused objectives: expedite your personal learning, build your network, and create a 12- to 18-month functional area strategy. Here is what you can learn from each of these transition goals and how to achieve it:

Expedite your personal learning: In order to uncover and understand cultural and operating norms, take time to understand the historical perspective and nature of the firm’s growth and processes by asking multiple stakeholders their insights. To understand procedures and processes, train on existing technology platforms and procedures. Gain insight on organizational dynamics and how decisions are made by observing interactions in a variety of settings (i.e., governance meetings, small team meetings). You can also meet with key decision-makers to learn about their influence and power in the decision-making process. Build your enterprise leadership knowledge by studying historical and current corporate, pipeline, and functional objectives. Review the firm’s risk register to understand the compliance and quality culture.

Build your network: Schedule routine meetings including weekly meetings with direct reports, bi-monthly skip-levels, and quarterly departmental meetings to assess direct reports’ strengths, career aspirations, motivations, and preferred leadership styles. You should also develop allies among decision-makers and influencers. To learn stakeholders’ priorities, pain points, and operating models, establish recurring stakeholder meetings based on department and position in the firm. Observe who makes the decisions, or who the team defers to for input. Cast a wide net for initial stakeholder meetings: At the end of meetings, ask who else should I meet with? Also determine which meetings beyond your scope of responsibilities require your participation.

Create your functional area strategy: Examine corporate objectives, current and future, through the lens of strategic planning. Revisit portfolio milestones, near- and long-term, at the enterprise and functional levels, and assess how your functional area supports the firm’s growth. Assess infrastructure, technology, processes, and procedures by reviewing the IT and infrastructure roadmap to identify opportunities for GxP system requirements and/or needs. To identify critical gaps in regulatory compliance and risk mitigation strategies, identify mission-critical initiatives that align with organizational strengths, weaknesses, and GxP compliance, and seek to understand stakeholders’ “worry list.” Assess organizational adaptability and readiness for change, and invest time in learning about existing projects and articulate your willingness to take on more. Seek strategic allies for endorsements by drafting an initial strategy to solicit their feedback.

To remain vigilant throughout the on-boarding process, hold yourself accountable through journaling. Writing promotes self-awareness and offers a mechanism for deep reflection. This introspective, continuous process of refinement of thinking allows GxP leaders to implement micro-adjustments real-time while building trust and credibility within the enterprise.

By establishing clear intentions at the onset of the job search and interview process, GxP leaders can sketch a blueprint to assess the culture and lead organizational change. As Will Rogers stated, “You never get a second chance to make a first impression.”

Katie H. Terry, Vice President, Quality, Acceleron Pharma Inc., Cynthia Ingols, EdD, Fellow, Institute for Inclusive Leadership, Professor of Practice (Retired), School of Business, Simmons University