We are currently looking for a Quality Director to join a leading Advanced Therapeutics company based in the Oxfordshire area. As the Quality Director you will be responsible for providing Quality oversight during the build of a new facility. This will including implementing a Quality Vision, Culture, Systems and building a Quality team.
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 will be eligible to operate within MHRA 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, cultures and teams.
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 all relevant Quality areas and will need to show managerial experience. The team will consist of various departments, including QA, QC and Operations. You will need to oversee the Audit plans, manufacturing and procedure Quality whilst ensuring there is adequate QA coverage throughout.
4. 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 or EMA 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 | ISO13485 | Med Device | 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.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Chris Carey
- Phone: 0203 910 2980
- Reference: J5635276
Website: Hyper Recruitment Solutions
- Posted: 15th July 2021
- Expires: 12th August 2021