Reference Number: JO-1910-438584
Associate Director/Director QA
Job Type: Permanent
ASSOCIATE DIRECTOR/DIRECTOR QUALITY ASSURANCE
Salary: Excellent/Dependent on experience and full bonus/benefits package
Our client, a young but exciting Biopharmaceutical company adopting solid strategies for the treatment of infectious diseases, is currently looking to recruit for a senior pharmaceutical/Biotech Quality Management specialist to take ownership of the UK Quality function. This is a responsible, autonomous role which will allow the successful candidate to fully utilise their extensive QA skills and knowledge.
As the Associate Director/Director QA, responsibilities will include (but not be limited to):
– Maintain oversight on company system to ensure procedures are in place to cover main activities and ensure procedures are updated regularly
– Reviewing and documenting QA approval of procedural documents before issue as per company policies
– Driving the development and execution of the Company GXP Audit Programme and conduct GXP audits including internal system audits, vendor audits, and investigator site audits.
– Managing, reviewing and finalising responses to audit reports in collaboration with relevant staff.
– Ensure the business is inspection ready at any time
– Implementing and maintaining a Company training programme related to GXP activities
– Managing CAPA process, issuing escalation and change management, derived from internal and external audits until closure.
– Providing consultation and direction on quality assurance and GxP compliance questions from supported functions.
– Supporting clinical product development programmes by attendance at project team meetings and providing quality inputs related to execution of the programmes in line with business needs.
– Working with GxP contractors as appropriate to deliver a comprehensive quality service
– Reporting to Director of QA on the performance of the quality management system and recommendations for improvement
The successful candidate will possess:
A Bachelors degree in a scientific/healthcare field.
– A minimum of 10 years experience in a GxP related biotech/pharmaceutical company with progressing roles of responsibility
– The ability to work autonomously as this position is a UK based role that reports into an Internationally based line manager
– Experience with clinical development as well as GMP process.
– Any Commercialization experience is a distinct advantage
– The ability to engage with stakeholders and negotiate Quality mandates across all levels of the organization.
This role represents an outstanding opportunity for a highly experienced senior Quality Management professional to make this role their own and play a major part in the growth of the business.
If you are interested in this opportunity Please call Jim Maddison at Scientific Professionals on +44 (0) 207 822 1710 or send an updated version of your CV via email to firstname.lastname@example.org
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