Head of Quality Deeside
Job description
Role: Head of Quality
Location: Deeside, CH5
Salary: circa £100k
Benefits Package: Private Health Insurance, Life Assurance, Potential for future Share Options, Enhanced Annual Leave, Enhanced Pension Contributions
The Company:
Reacta Healthcare, established in 2013, operates from a pharmaceutical manufacturing facility in Deeside, North Wales. The GMP facility is licenced to manufacture oral challenge meals, for use in clinical trials, as auxiliary medicinal products. The Reacta Healthcare challenge meals are currently used to diagnose and monitor food allergy in numerous global therapeutic trials. The business is progressing along a strategic path to marketing authorisation. Patents for the challenge meals have been granted in a number of countries.
Reacta Healthcare is responding to the rapidly evolving food allergy environment, future plans include expansion into niche areas of food allergen development and manufacture beyond challenge meals.
The Opportunity:
Reacta Healthcare is a young, entrepreneurial, and fast-growing organisation, positioned for great things! We have a fantastic opportunity for a Head of Quality to join the team. This hands-on role is a unique opportunity to be an integral part of the success story. A key role as part of the Senior Leadership Team, the Head of Quality will have the opportunity to further develop both the Quality Assurance and Quality Control functions, supported by our internal teams and external consultants where appropriate.
The ideal candidate will have substantial experience in pharmaceutical manufacturing, coupled with a detailed understanding of the relevant UK Human Medicines Regulations, European Regulations, and international cGMP standards to fulfil obligations.
The role includes the following key accountabilities:
Key Accountabilities
- Provide governance of, and support to ensure ongoing compliance of the site Pharmaceutical Quality Management System with all applicable standards and guidelines.
- Promote across our whole site an awareness of and commitment to the quality standards and objectives required by the business, through effective motivation, communication and training.
- Effective direction, leadership, and development of the quality team (QA and QC) in support of the business as a whole.
- Ensure QA/QC operations operate effectively and efficiently.
- Ensure the provision of sufficient and appropriate resources to enable the overview of manufacture of Reacta Healthcare products and ensure systems are in place to support selection and approval of new suppliers of products, materials, and services.
- Oversight of in house development laboratory, contract laboratories and stability studies to ensure the continued safe use of products.
- As a person named on the companys manufacturing authorisation, the job holder is personally and professionally accountable for the quality of all products certified for release.
-
Lead role with regulatory authorities (MHRA and other regulatory authorities), as required in company inspections.
Decision making authority for:
- Materials/Products (approval/rejection)
- Production cGMP operating standards,
- Contract manufacturing approval,
- Recruitment of relevant staff.
Advice given on:
- Plant design and operation in accordance with cGMP requirements.
- New product development and new product introduction in accordance with applicable cGMP requirements
Essential Skills, Qualifications and Experience
To be successful in this role, applicants need to have the following essential skills and experience:
- Extensive experience of pharmaceutical manufacturing.
- Extensive experience of Pharmaceutical Quality Systems.
- A scientific degree.
- Detailed understanding of the UK Human Medicines Regulations, European Regulations, and international cGMP standards to fulfil obligations.
- Substantial operations experience, along with a proven track record of successes and achievements.
- Proven leadership expertise, with a pragmatic approach.
Desirable Skills and Experience
- Eligible to be nominated as a Qualified Person on a manufacturing authorisation.
- Experience of manufacture of clinical trial products.
- Experience of manufacture of medicinal products with a marketing authorisation.
Do you want to feel inspired every day? We are future-focused, and our business is growing rapidly. We succeed together through passion, commitment, and teamwork, and so can you.
