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Reporting to: CEO / Operations Director
Location: Ideal candidate would be located close to Reading & London sites, with occasional travel to Manchester site expected
Package: Competitive salary + annual bonus + car allowance
About Healthxchange
Founded in 2000, Healthxchange is the leading supplier of medical aesthetic products and services to professionals across the UK & Ireland. Healthxchange proudly partner with award-winning brands including Obagi Medical, Medik8, Jan Marini, and Jane Iredale to strategically commercialise their products in market. We currently supply over 9,000 clinics with a full range of products (Skincare, Injectables, Energy-based devices) and services (software & education) to support their 360 business needs. The company offers a dynamic environment for innovation and growth in the medical aesthetic space.
About The Role
We are seeking a highly skilled and experienced individual to join our team as the Head of Quality (QA) in the UK. This person will act as Responsible Person (RP/RPi) on our Wholesale Dealers Authorisation (WDA) & Quality Controller (QC) on our Manufacturers Specials (MS) Authorisation. The successful candidate will be responsible for ensuring the group activity consistently meets or exceeds Good Distribution & Manufacturing Practices (GMDP) in compliance with the scope of our licences.
The successful candidate should have extensive experience operating as RP/RPi for a full scope WDA licence (excluding brokering) covering PoMs, P-medicines and GSLs. The candidate should also have relevant experience importing unlicensed medicines via the NOI process, in their role as QC or similar.
The preferred candidate should have a scientific medical background and relevant experience in the aesthetics industry, with a deep understanding of regulations governing the key products we distribute (Medicines (e.g. Botox), Medical Devices (e.g. Fillers) & Cosmetics(e.g. Skincare)).
Responsibilities
- Responsible for Healthxchanges Medicines licenses; namely WDA(h) & MS licenses
- Develop, implement & maintain a comprehensive strategy to ensure that the Group complies with guidance, regulation and the scope of Licenses held, particularly in relation to wholesaling and importing medicines, medical devices and cosmetic products in the UK
- Duty to report all relevant compliance issues to the CEO
- Maintain our Quality Management System (QMS) including document control, change control, validation management (systems and plant (PPM)), deviation management, CAPA (Corrective and Preventative Action) programs, complaint management and standard operating procedure (SOP) management and oversight
- Lead internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations
- Provide guidance and support to cross-functional internal teams on QA related topics
- Drive continuous improvement initiatives to enhance QA systems, processes & performance
- Deliver GDP/GMP training to internal colleagues to ensure staff are consistently aligned with industry body regulations and expectations
- Develop a suite of QA KPIs to measure and broadcast the efficacy of Quality within Healthxchange including trends and areas for improvement
- Ensure timely resolution of QA related issues and deviations to minimize risk to customers, patients and Healthxchange supply chain of products
- Collaborate with external industry bodies to ensure compliance at Healthxchange is appropriate to current legislation
- Serve as the primary point of contact for external agencies and clients in support of QA/Regulatory matters including audit management at Healthxchange
- Mentor and develop QA and Regulatory Team members to build a high-performing and engaged workforce
- Act as approver of all marketing materials in relation to medicines or medical devices
Additional
- Flexible to commute across all Healthxchange facilities
- Excellent awareness of global supply chain regulations, post Brexit, to ensure Healthxchange are constantly ahead of key changes to compliance eg: Windsor Framework
Requirements
- Batchelors degree in either pharmacy, life sciences or related field
- Minimum of 10 years experience in a QA role managing complex product flow within a global supply chain industry
- In-depth knowledge of Regulatory requirements eg: MHRA, FDA, HPRA (preferred), GDP, GMP, GxP, RP & RPi & QC duties and responsibilities
- Proven track record of leading QA GDP/GMP/GxP strategy and driving continuous improvement programs
- Strong analytical, problem-solving and decision-making skills
- Excellent communication and interpersonal skills with the ability to collaborative effectively across all business functions and organisational levels
- Demonstrate leadership capabilities including the ability to mentor, inspire and motivate team members
- Previous experience in managing a QMS within a global supply chain environment
- Deep knowledge of products handled in aesthetics industry
Benefits
Company pension, annual bonus, 25 days holiday plus bank holidays (and increasing with service), staff discount, staff social events, access to Health Assured EAP.
