QA Manager/AD Quality Assurance
If you are inspired by developing your career in a stimulating environment where you can make a profound difference to the healthcare of patients, my client can offer exceptional careers for exceptional people. Based on an established Bioscience campus in Cambridge, you will have the opportunity to work with smarter science, unique technologies and highly experienced scientific leaders.
The company is engaged in the discovery and development of human monoclonal antibody therapeutics using novel monoclonal antibody therapeutic platforms
They are looking to recruit a QA Manager or Associate Director of Quality Assurance to ensure that appropriate quality standards are adopted throughout their growing business & to monitor & maintain compliance with these standards.
Assist the VP of Quality in defining a Quality Management System (QMS), encompassing all relevant company activities
Ensure that the QMS meets all necessary regulatory requirements, including good-practice guidelines and standards, with specific emphasis on GCP compliance
Work with the VP Quality and Development teams to implement the QMS as an enabler for delivery of the client's programmes
Maintain and control the implemented QMS
Implement defined quality standards and metrics to monitor compliance
Provide support and advice to Development teams with regards to management of quality issues
Ensure that quality issues do not compromise or impede progress of programmes
Ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented according to procedures
Monitor the performance of GxP service providers with regards to the relevant quality standards required to support activities
Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified
Maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company
Education and Experience
Comprehensive knowledge of GCP requirements as applied to biologics
Basic understanding of GLP and GMP requirements for biologics
Substantial experience of managing quality issues in a biotechnology or biopharma setting
Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharma companies
Proven track record of monitoring and influencing internal client group quality compliance, including conducting self-inspection audits
Proven track record of monitoring and influencing the quality performance of contracted service providers, including external audit experience
Skills and Knowledge
Excellent communication skills
Excellent negotiation and influencing skills
Highly developed conflict resolution abilities
Conversant with quality requirements of EU directives and ICH biologics guidelines
In-depth knowledge of GCP and related industry/regulatory guidelines governing clinical trials in the UK, EU & USA
Knowledge of cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US
Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines
Ability to find pragmatic solutions for quality issues in a highly agile biotech environment
Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
Can you see yourself being part of a company that celebrates diversity and believes that better thinking and decisions come from wider experience? If the answer is yes and you have a desire to be an integral part of a dynamic team, we would be keen to hear from you. In the first instance, please send your CV to Matthew Walsh: email@example.com . We endeavour to come back to you within 24 hours of CV submission.