CMO Quality Manager

Ipsen Pharma

London, Boulogne, Wrexham or Dublin

Job Description:

The CMO Quality Manager - External Manufacturing will lead the quality oversight of partners under its responsibility, provide quality leadership, technical quality expertise and guidance to internal cross-functional teams. In this role you will work in collaboration with others within the Quality department. You will be an expert in Quality Assurance with the gravitas and maturity of experience to work with our manufacturing partners, joint ventures, and our own manufacturing community. The role will also ensure that the highest standards of Quality Operations (QA & QC) are implemented and maintained at Contract Manufacturing Organisations (CMOs) and Contract Laboratories.

The successful candidate will need to show the following Key Technical Competencies:

QA and QC experience for products manufactured by CMOs including regional, national, and international audits
Extensive experience of Internal & External Quality auditing, CAPA management deviation management & risk assessments
Strong domestic and international regulatory inspections compliance background and detailed knowledge and application of cGMP, GDP, ICH regulations and international regulatory expectations.
Knowledge of biotech and aseptic, synthetic small molecule and formulation processes with the ability to creatively problem solve
Ability to influence external and internal stakeholders in a multicultural environment.

Experience & Qualifications

Ideal: MSc in a Life Sciences discipline. 7 years hands-on experience gained in Quality Assurance in contract manufacturing environment. Experience in Drug Substance and control testing labs would be a plus. Minimum: 5 years hands on experience on manufacturing site (Quality assurance, validation, production)

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