Associate Director, Quality Control

This is what you will do:

The management and oversight of the following QC activities: analytical microbiological; sample management; direct laboratory testing support; equipment management & maintenance support to ensure fully compliant effective and safe Quality Control laboratories. The compliance and inspection readiness of all Quality Control activities on site and in line with regulatory and quality standards related to the testing of Alexion products per respective licensed specifications as well as technical support of new products registrations filings.

Lead and support QC forums and provide technical expertise in support of the Alexion Athlone operational functions & network.

You will be responsible for:

Provide leadership and oversight to the QC laboratory functions ensuring the full application implementation and adherence to current testing standards as well as EHS standards maintaining effective compliant and safe QC laboratories in accordance with GMP and EAEU requirements.

Accountable for review approval or rejection of all raw materials packaging materials intermediates bulk and finished products by ensuring these meet approved specifications and quality standards before release use or distribution.

Accountable for review and approval of all QC-related specifications sampling procedures test methods instructions and procedures ensuring their suitability relevance and regulatory compliance prior to implementation or update.

Ensure the establishment validation/qualification calibration and routine maintenance of all QC equipment and laboratory systems in accordance with internal and regulatory requirements to support accurate and reliable testing.

Oversee and ensure the formal recording review evaluation and retention of all QC test data guaranteeing data integrity traceability and readiness for internal and regulatory audits.

Monitor and control QC testing processes ensuring adherence to agreed lead times and compliance with approved methods and specifications.

Provide QC review and formal approval on relevant QC documentation as required to support the release of pharmaceutical materials and products in compliance with regulatory expectations.

Implement communicate and continuously maintain all QC Standards Procedures and GMP documentation ensuring ongoing compliance continuous improvement and readiness for inspection.

Ensure standardized QC practices and systems across all site QC functions and champion the implementation of Operational Excellence principles including Continuous Improvement and Digital Strategy.

Represent the QC function at regulatory corporate and internal inspections audits and quality forums ensuring all QC-related requirements are understood and demonstrated.

Oversee the recruitment development and retention of all QC staff ensuring suitable training qualification and competency management to deliver a flexible and robust QC workforce.

Lead the local design and execution of the global QC strategy and deployment ensuring alignment with corporate objectives and compliance standards.

Establish and maintain effective communication and networking with Quality professionals both internally and externally to ensure the ongoing application of evolving Quality Laboratory standards and regulatory requirements.

You will need to have:

A minimum of 15 years experience in a pharmaceutical or biopharmaceutical company in roles with increasing responsibility in quality leadership

BSc in Biochemistry Chemistry Microbiology or other life sciences. An advanced degree (MSc/PhD) is an advantage

Extensive GMP laboratory/Quality management within a multi-national pharma/biopharma company is essential.

Proven ability to build mentor and grow agile high performing teams

Knowledge of business and management principles involved in resource allocation financial management leadership and co-ordination of people and resources.

Proven ability to work in a matrixed organization

Extensive experience of the all regulatory requirements associated with QC methods submissions & variations

We would prefer for you to have:

Experience in a leadership role within a biopharmaceutical company.

Skilled in organisation planning and priority setting.

Previous experience in handling regulatory audits and inspections.

Experience working in a global and diverse work environment.

Date Posted

Closing Date