Regulatory Affairs Manager Permanent GlasgowAre you an experienced Regulatory Affairs Manager looking for a new challenge?Do you have experience working within medical devices or a...
Director / Head of Quality and Regulatory - Permanent
Do you have quality management experience within the biopharmaceutical industry?
Can you perform well in a fast paced environment?
Can you drive and maintain a quality culture and build a high performance quality team?
Do you appreciate strong Company values? Then you will fit in well with our client - Sartorius Stedim BioOutsource Ltd.
On behalf of our client are looking for outstanding individuals who want to make an impact on the business and can work effectively to deliver targets, manage by example and drive standards.
Sartorius Stedim BioOutsource Limited is the world's fastest growing provider of contract testing services to the biopharmaceutical industry. Their core offering includes a wide range of GMP, GLP and GCP tests to support Biologics and Vaccines therapeutics from their development to release into the market.
SRG are looking for an experienced Director / Head of Quality and Regulatory to be responsible for the strategic direction of the Cell & Testing Services (CTS) Quality groups in Glasgow, Cambridge (USA) and Laupheim (Germany). The incumbent is responsible for Regulatory compliance of all CTS sites to the appropriate FDA, EU and local requirements as well as providing strong regulatory advice and strategy, both internally and externally. The successful candidate must have experience in applying EU and US GMP manufacturing regulations as well as being able to demonstrate excellent organisational and leadership skills.
In return our client can offer you a competitive salary, a generous benefits package and significant opportunity for personal growth and development within a rapidly expanding successful CRO.
What you can look forward to achieving
- Maintaining regulatory licenses (e.g. MA(IMP)
- Ensuring that GMP, GLP and GCP compliance is maintained throughout our testing facilities and IMP licenced cell bank manufacturing facility.
- Develop and implement a shared CTS quality framework across all sites.
- Design, effective implementation and monitoring of the QMS systems to meet the appropriate compliance, user, client, and business requirements.
- Build a high performance Quality team
- Responsibility for Head of QC duties as specified in Eudralex, Volume 4
- Promote and maintain a Quality culture throughout the organisation.
- Develop a client Regulatory support service
Skills and experience you need to bring to the Company
- A degree in a relevant scientific discipline is desirable
- Previous experience in a senior quality role within a licensed drug or biologic facility regulated by FDA, EMEA is essential
- Experience in implementation of automated systems is also essential
- Proven practical application of the relevant Regulations is essential, particularly:
- Directive 2001/83/EC, Directive(s) 2003/94/EC and 2011/62/EU
- Directive 2001/20/EC
- 2003/94/EC; Eudralex Volume 4
- QP training is desirable
- UK Good Laboratory Practice Regulations, 1999 [Statutory Instrument 3106, as amended),
- Good Clinical Practice for testing laboratories
- Be the Subject Matter Expert in at least 1 area of validation (assay, equipment, CSV)
- Have a Collaborative and Innovative style with the ability to challenge and simplify complex systems
- Proven Regulatory Compliance success within a GMP or GLP environment
- Demonstrate leadership and motivational skills to create high performance teams
- Thorough understanding and experience applying EU and US GMP or GLP regulations
- Extremely organised approach is required coupled with the ability to influence without authority
- Excellent written and verbal communication skills coupled with the ability to prioritise multiple tasks and have the confidence to challenge existing systems & processes.
- Competent in Word, Excel and PowerPoint
- Working knowledge of current pharmaceutical production technologies, QC procedures, and regulatory requirements.
If you are interested in this exciting opportunity please apply online or contact Pamela for further information.
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.