Distribution QA Director – RP/RPi
The Distribution QA Director will play a central role in shaping and strengthening the group's distribution quality organization. Working in close collaboration with the Head of QA this position will define strategic objectives and deliver on targets related to distribution QA activities.
Beyond ensuring compliance, the Distribution QA Director will coordinate with the network of Responsible Persons fostering alignment, expertise, and efficiency across the organization. The role will also be instrumental in contributing in the harmonization of distribution processes, providing strategic insights into supply chain and logistics practices to support the ongoing transformation of the group's wholesaling activities.
Finally, the QA Director will act as Responsible Person (RP) and Responsible Person for Import (RPi) in the UK, a regulatory requirement essential to the continuity and compliance of our operations as a pharmaceutical wholesaler.
If you are keen to join a patient centric, high-growth company, then read on and apply today
What You Will Do
In addition to the regulatory accountabilities of the Responsible Person/Responsible Person for Import (RP/RPi), the QA Director will provide strong managerial leadership to engage, align, and inspire the QA/Responsible Persons network and ensure a culture of quality and compliance across the organization. The scope of responsibility includes not only UK distribution activities but also oversight of export distribution operations. Key duties include, but are not limited to:
Regulatory Compliance & Oversight
* Ensuring the provisions of the Wholesale Dealer's Authorisations (WDA) are fully observed.
* Maintaining compliance with MHRA regulations, EU GDP Guidelines (2013/C343/01), Human Medicines Regulations 2012 (as amended), and the current Rules and Guidance for Pharmaceutical Distributors (UK).
* Acting as RPi for the release of imported products into the UK market, in accordance with Annex 16
* Liaising with the MHRA regarding inspections, audits, and compliance issues, while preparing for and participating in such inspections.
Quality Management & Process Leadership
* Establishing, implementing, and maintaining effective Quality distribution processes System (QMS), with clearly defined systems, procedures, and responsibilities, ensuring permanent inspection-readiness.
* To maintain GxP compliance regulations to ensure that the applicable standards and regulations are adhered at all times. This includes following of standard operating procedures and approved written documentation.
* Driving harmonization and continuous improvement of distribution quality processes and SOPs in close collaboration with stakeholders.
* Overseeing audits within his/her field of responsibility, approving audit plans, and ensuring timely completion of internal and external audits related to distribution process.
* Ensuring adequate records are maintained to demonstrate ongoing GDP compliance.
Distribution Oversight (UK & Export)
* Supervising and ensuring compliance of both UK and export distribution activities.
* Approving export orders and monitoring related compliance requirements.
* Providing strategic input to strengthen efficiency, risk management, and compliance in global distribution flows.
Decision-Making & Risk Management
* Deciding on the fate of returned, quarantined, counterfeit, falsified, or recalled goods, including timely communication with Competent Authorities.
* Overseeing mock recalls, compliance checks, and product portfolio controls to safeguard quality and patient safety.
* Approving GDP-related change controls, deviations, and complaint reports, ensuring trends are analysed and acted upon.
Supplier, Partner & Stakeholder Management
* Ensuring suppliers, distributors, and customers are qualified and subject to annual bona fide checks.
* Preparing, reviewing, and approving Quality Technical Agreements with distribution partners.
* Providing GDP input for Product Quality Reviews (PQRs)
Leadership, Training & Culture
* Providing managerial guidance and leadership to the QA/RP network, fostering collaboration and consistency across the organization.
* Promoting a strong quality culture, encouraging adherence to the highest compliance standards, and ensuring that all staff are trained in GDP and fully understand their responsibilities.
* Acting as a key point of reference within the company, bringing expertise, vision, and influence to strengthen supply chain and logistics processes while maintaining compliance.
What We Do
Essential Pharma is a global pharmaceutical company working to make a difference for patients in niche populations.
Everything at Essential Pharma is driven by the fact that every patient matters. We are focussed on developing and delivering medicines for patients in small, underserved or rare disease populations. Our team of 70+ people has an entrepreneurial spirit, challenging convention and working creatively to deliver results. Our headquarters are in Surrey, UK, and we have offices in Malta, France, Spain and Switzerland.
We are an international business, with a growing product portfolio that reaches patients in approximately 70 countries. We cover multiple therapy areas with a particular focus on rare disease, CNS, ophthalmology and gastroenterology. Our first development-stage asset is an anti-GD2 antibody for the treatment of high-risk neuroblastoma. We have a proven track record of acquiring, investing in and commercialising treatments.
What You Will Bring
Qualifications
* Master's degree in pharmacy (e.g., Pharmacy, Chemistry, Biology) or Engineering degree
* Eligible to a RP/RPi position
Experience
* Significant experience as Responsible Person / Responsible Person for Importation
* Demonstrated experience supporting or managing quality system processes (e.g., Deviation, CAPA, Change Control)
* Expertise on EU GDP guidelines, MHRA expectations and Supply Chain process
* Familiarity with electronic Quality Management Systems such as Veeva.
* Previous exposure to similar pharmaceutical business models and third-party oversight desirable
Core Competencies
* Strong attention to detail and documentation accuracy
* Effective problem-solving skills and critical thinking mindset
* Able to work independently with minimal supervision
* Collaborative, strongly team-oriented approach
* Additional European language is a plus (German, Spanish, French)
* Strong communication skills, both written and verbal
* Results-driven with a continuous improvement mindset.
What We Offer
* Competitive salary
* We understand that productivity requires balance, so we offer office-based contracts and allow flexibility on locations of work when required and appropriate. This can be different for each department so please have that conversation at interview
* £150 towards your home office
* Healthcare
* Pension – you contribute 5% and we offer 5%.
* Life Insurance – lump sum (tax free) death benefit of 4 x basic salary.
* Enhanced family leave
* Enhanced sick pay
* 25 days annual leave
* Discretionary annual performance bonus
What To Expect
* At Essential Pharma, every colleague matters: we want every member of the team to thrive and grow during their time with us
* Right from the interview stage, we encourage candidates to ask us questions, voice opinions and be curious
* This is a dynamic, fast-paced working environment. We expect individuals to be responsible and accountable, while understanding the importance of collaborating with colleagues to fuel success
* We pride ourselves on our inclusive culture, based on the belief that everyone brings unique strengths and perspectives
* We have an unwavering dedication to employee growth and development