Quality Manager & Deputy Responsible Person (RP)
Reporting to: Head of Quality & Responsible Person (RP)
Location: Flexible London Reading and Manchester
Compensation: Competitive salary annual bonus
About Us:
Founded in 2000 Healthxchange is the leading supplier of medical aesthetic products and services to professionals across the UK & Ireland. Healthxchange proudly partner with awardwinning brands including Obagi Medical Medik8 Jan Marini and Jane Iredale to strategically commercialise their products in market. We currently supply over 9000 clinics with a full range of products (Skincare Injectables Energybased 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:
The Quality Manager & Deputy RP supports the Responsible Person in maintaining compliancewith Good Distribution Practise (GDP) guidelines to ensure the Quality safety and integrity of products throughout the Healthxchange supply chain. Reporting to the Head of Quality the Quality Manager will collaborate closely with crossfunctional teams to identify areas for improvement and support the implementation of best practices touphold our commitment to Quality.This role will also include the added responsibility of acting as the Deputy Responsible Person (RP).
Responsibilities:
- Support the implementation & maintenance of Healthxchanges commitment towards Quality towards GDP GMP GxP Pharmacy (oversight with support ex SI Pharmacist) & Regulatory standards
- Provide daily support towards Healthxchanges operations licences at all sites; namely WDA(h) & MS licenses
- Assist the RP in implementing and maintaining Good Distribution Practise (GDP) standards across all Healthxchange operations
- Act as the Responsible Person in the RPs absence ensuring that all GDP related activities continue uninterrupted
- Oversight and maintenance of our QA 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
- Document and report any deviations or issues identified during daily tasks
- Assist in the development and maintenance of procedures protocols and departmental documentation
- Support customer and vendor approval process with Head of Quality
- Partake and support internal and external audits to assess compliance whilst continually removing risk from Healthxchange operations
- Provide guidance and support to crossfunctional internal teams on QA related topics
- Drive continuous improvement initiatives to enhance QA systems processes & performance
- Maintain and support GDP/GMP training to internal colleagues to ensure staff are consistently aligned with industry body regulations and expectations
- Assist the Head of Quality with the management and broadcast of QA KPIs to measure 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
- Support the Head of Quality in communications with external agencies and clients in all matters pertaining to QA/Regulatory including audit management at Healthxchange
- Mentor and develop QA and Regulatory actions across all colleagues at Healthxchange
Requirements:
- Batchelors degree in related field (Quality Assurance life sciences etc)
- Minimum of 5 years experience in a QA role preferably in a pharmaceutical medical device global supply chain industry
- Strong knowledge of Quality Management Systems (QMS) and regulations (GDP GMP GxP)
- Strong analytical problemsolving and decisionmaking skills
- Effective communication and interpersonal skills
- Excellent attention to detail with strong analytical skills
- Ability to work independently and collaboratively across multiple crossfunctional
department - Preferred knowledge of Lean Six Sigma principles and methodologies
- Proficient in Microsoft Office Suite (Word Excel PowerPoint)
- Flexible to commute across all Healthxchange facilities
Benefits
Company pension annual performance bonus 25 days holiday plus bank holidays (and increasing with service) staff discount staff social events access to Health Assured EAP.
Healthxchange is committed to creating a diverse and inclusive work environment. We are proud to be an equal opportunity employer and we welcome and encourage applications from all qualified individuals regardless of race colour religion sex sexual orientation gender identity national origin age disability status marital status or any other legally protected status. All employment decisions are based on merit qualifications and business needs.