AX-7199 Global CMO Quality Assurance Manager
This Global specialty-driven biotechnology company is looking for an ambitious QA Manager to provide quality and strategic oversight working closely with it’s global manufacturing partners.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
Launches anticipated over the next 2 years
Excellent potential for career development within the QA group including succession planning into QA Director role in the mid-term
Flat structure with every role in the QA group offering high exposure to company senior leadership team
Travel 15% to 20%
Deploy and maintain GxP Quality Management Systems with CMOs and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.
Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.
Escalate critical quality issues are reported to senior management using the Global Quality alert process.
Review and sign-off of master production, process validation and cleaning validation documentations provided by CMOs.
Carry out the disposition of Finished Products, APIs, Raw Materials and Components when required.
With the Director of Quality and Director of Relationship Management, develop a quality strategy aligned with the overall business strategy
Reduce and mitigate product risks as well as developing opportunities for improvement
Identify, remediate and mitigate risks associated with company products and systems
Identify and implement opportunities to simplify business processes including sampling, testing and data generation.
Support initiatives to meet or exceed Quality objectives. Contribute to continuous improvement planning and execution.
Contribute to the deployment of the Global Technical & Quality roadmap for External Manufacturing.
QUALIFICATIONS / EXPERIENCE REQUIRED:
Degree in a Life Sciences discipline, ideally in Pharmacy, Chemistry, Microbiology or Engineering
Significant hands-on experience gained in both Quality Assurance and Quality Control departments
Thorough knowledge of cGMP guidelines gained through practical experience of supporting cGMP manufacturing operations.
Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Preparation for FDA and EMA inspections.
Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.
Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button.
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AXESS has been operating since 1990
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