Head of Quality
2 days ago
**Head of Quality & Compliance**
I am currently working on an exciting Head of Quality & Compliance hire for a start up Pharmaceutical company in Birmingham (3 days a week on site required) who are looking for an experienced Quality Assurance leader to join the team on a permanent basis.
For both of these, the individual will lead the team's efforts to be 'GMP ready' in an efficient manner. This will involve leading all quality executives and overseeing all GMP-related functions (eg, R&D), preparing all necessary documents for inspectionand ensuring the facility, equipment etc is ready.
This clearly requires deep GMP experience, but also experience in project managing a team to tight deadlines and planning ahead. As an early stage business, we have to deliver in an efficient timeline.
Key Responsibilities:
- Lead on the regulatory MHRA, FDA and GMP compliance for all licence submissions (Manufacturing Specials initially) - including all correspondence with MHRA inspectors and mock auditors
- Project manage the team to hit deadlines
- Lead, manage, support and develop the QA and QC teams to assure effective operational performance and compliance
- Create the Departmental strategy objectives and goal setting
- Lead on regular (daily) site walk-arounds to ensure GMP compliance
- Oversee all GMP-related and QMS activities on day-to-day basis
Key Requirements:
- 20+ years experience in a Quality management role in Pharmaceuticals with deep understanding of both UK regulatory market (and US ideally):
- GMP (including MHRA inspections)
- Manufacturing Specials
- APIs
- Natural medicines
- Experience of leading a quality team
- Understanding of MHRA (and ideally FDA in US) regulatory frameworks
- Strong knowledge of manufacturing drug substances
If this Head of Quality & Compliance role in Birmingham looks as though it could be the next step in your Pharmaceuticals career, please get in touch ASAP
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England andWales
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