5 Top Tips for Qualified Persons (QPs) to Excel in Pharma Compliance and Leadership

Article By Michelle Yeomans, EPiC Operations Manager

Qualified Persons (QPs) are a pillar of pharma quality assurance and GxP compliance. Whether you’re a trainee or an experienced Contract QP, mastering leadership, regulatory updates, and GMP compliance is essential for successs. 

During 2025 EPiC Consultants have been proud to present at several pharma industry conferences with the specific aim of supporting Qualified Persons (QPs).

QPs play a vital role in ensuring that the highest standards in manufacturing and compliance are maintained.

They remain the backbone of Quality Assurance and Compliance and work in partnership with the Marketing Authorisation Holder (MAH) to ensure the safety, quality and efficacy of a medicinal product over its lifetime.

Best practices for QPs in pharmaceutical manufacturing

The Joint Professional Bodies of the Royal Pharmaceutical Society, Royal Society of Biology, and Royal Society of Chemistry publish a study guide for QPs which details the knowledge and practical experience required by QPs involved in the manufacture of pharmaceuticals in the UK.  The guide serves as the standard for all three bodies in verifying QP candidates and can be found here:     QP Study Guide April 2025.pdf

1. Master Time Management Early for QP Success – Balancing a demanding day job with QP training and personal commitments is no small feat. Many aspiring QPs struggle to find time for study, application form completion, and site visits. 
   Tip: Treat your QP journey like a project. Block out dedicated time in your calendar for study and form updates. Use productivity tools and set achievable milestones to maintain momentum without burning out.

2. Stay Ahead of GxP Regulatory Changes and Industry Trends– The GMDP regulatory landscape is constantly evolving, and QPs must keep pace with regulatory requirements, updates, industry trends and hot topics in pharmaceutical manufacture across multiple regions. Falling behind can lead to self-doubts making decision-making harder and increase compliance risks. 
   Tip: Make continuous learning part of your routine. Subscribe to regulatory newsletters, attend webinars, and join professional forums. Staying informed on GMDP regulatory requirements as well as maintaining an awareness of industry trends by investing time in building foundational knowledge of product innovations such as Point of Care Personalised Medicines and emerging technologies such as AI and data driven tools help you remain confident and compliant.

3. Build a Strong Network as a Qualified Person- Networking isn’t just about career progression, it’s a lifeline for gaining diverse experience and practical insights. Many QPs credit their success to connections that opened doors to site visits or shared real-world scenarios.   
   Tip: Engage with peers at industry events, join QP-focused groups on LinkedIn, and seek out mentoring for QP’s. A strong network can provide guidance, opportunities, and reassurance when tackling unfamiliar challenges such as contract QP responsibilities or multi-site oversight. Make use of free resources such as our article: Top Tip for Influencing GMP Compliance as a Leader or QP

4. Develop Soft Skills for Pharma Leadership – Technical knowledge alone won’t make you an effective QP. The role often requires influencing decisions, managing conflict, and guiding cross-functional teams without formal authority. 
   Tip: Invest in leadership and communication training. Practice scenario-based decision-making and learn to articulate your reasoning clearly. These skills will help you navigate complex situations and earn trust across the business, especially when working as a Contract QP or in a Strategic Leadership role. 

5. Embrace Grey Areas with Confidence in GMP Compliance– QP decisions aren’t always black and white. Batch disposition under pressure, supply chain disruptions, and borderline compliance issues are part of the reality. 
   Tip: Always prioritise patient safety and regulatory compliance. Document your rationale thoroughly and don’t hesitate to seek peer input and be prepared to listen to allow insights and perspectives to inform your decision making. Take time to think through the scenario and possible outcomes to understand the risks to patient safety, product quality, data integrity and regulatory compliance. Based on the risks identified, consider what mitigations and CAPA are already in progress to provide reassure that things are under control. A clear and succinct explanation will help provide confidence in your decision making that will stand up to scrutiny from the MAH and regulatory inspector.    

The QP role is as much about judgment and leadership as it is about technical expertise. By focusing on time management, regulatory and industry awareness, networking, soft skills, and handling uncertainty in decision-making, you’ll be well-equipped to meet the challenges head-on and make a meaningful impact in your organisation.