Qualified Person We are currently looking for a Qualified Person (QP) to join a leading biologics company based in the Oxfordshire area. As the Qualified Person you wi... View Job
Qualified Person We are currently looking for a Qualified Person QP to join a Pharmaceutical company based in the South East. As the Qualified Person QP you will be re... View Job
Quality Assurance Officer Hyper Recruitment Solutions are currently looking for a Quality Assurance Officer to join a leading Pharmaceutical business based in the Wiltshire are... View Job
We are currently looking for a Quality Director to join a leading biologics company based in the Wiltshire area. As the Quality Director you will be responsible for directing and implementing strategies across the business, ensuring compliance with EU and US regulations. You will also assist the company with their commercial growth plans, advising how they must operate to be compliant.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Director will be varied however the key duties and responsibilities are as follows:
1. You will need to ensure that the site is currently operating within MHRA and FDA regulations and that all quality systems are in compliance with these regulations. You will need to keep updated with changes in regulations and own the development plans of the quality systems.
2. You will work extremely closely with the Senior Leadership Team and will need to have the gravitas and commercial awareness to advise and encourage stakeholders. As the Quality Director, you will advise the senior leadership during their exciting growth, on quality standards.
3. As the Quality Director, you will take charge of the current Quality Team and will need to show managerial experience. The team will consist of Head's of Quality and QA Officers working in different specialisms. You will need to oversee the Audit plans, manufacturing and procedure Quality whilst ensuring there is adequate QA coverage throughout.
4. You will work closely with the site Qualified Persons (QPs) ensuring batch release schedules are adhered too. Although you are not expected to be a QP for this position, it would be advantageous.
To be successful in your application to this exciting opportunity as the Quality Director we are looking to identify the following on your profile and past history:
1. Prior experience managing a Quality Assurance unit within a Pharmaceutical or Life Science industry. Any experience at executive or board level would be beneficial, along with experience working within a sterile business.
2. Prior experience working and liaising with regulatory bodies, such as the MHRA, FDA is essential. You will be the lead contact with the regulatory bodies and will be the point of contact.
3. Experience in a commercial manufacturing site.
Key Words: Quality Director | Quality Assurance Director | Director | QA | Quality Assurance | MHRA | Life Science | Pharma | Biologics | Regulatory | Audit | QMS | Development | Commercial | Manufacturing | Aseptic
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.