Senior Quality Assurance Manager

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases.

See Yourself at Telix

This role will contribute to the achievement of the Group's strategic goals by leading the quality management of the Marketing Authorization (MAH) and distributor site, Telix Innovations SA, following the GMP and GDP requirements. As Senior Quality Assurance Manager, it is expected that the candidate has the Quality Assurance responsibility and leadership related to the MAH and the distribution activities, staff and operations for the related TLX programs.

This position will coordinate and assist in the active management and implementation of the Telix commercial program/s as directed, including aspects of quality requirements. It will also actively participate in and support the quality needs of the commercial programs across the organisation's country jurisdictions. This role will provide support to other TLX programs and other team members as required, and interact with key staff in Australia, or the US as required.

This position is located in Herstal (Telix Innovations SA), Belgium, and reporting to the Quality Director, Site Quality - QP, RP, & Radiopharmacist. A 4-day on-site presence is expected in the role.

Key Accountabilities:

* Understand and adhere to GMP Policies.

* Prepare, review and approve documents within Telix Quality Management System (QMS) and eQMS, Master Control:

* Develop and implement standard operating procedures (SOPs).

* Review protocols, summary reports, SOPs to ensure that documentation is accurate and complete.

* Support the review of the product specifications in collaboration with the QC department to ensure that documentation is accurate and complete.

* Develop electronic document management system.

* Develop the training program to ensure the ongoing training of current staff.

* Participate in the management of internal quality audits on all Telix systems within the QMS, prepare reports and recommend solutions and close out activities under the guidance of the local Director of Quality.

* Participate in the management of supplier quality audits and agreements.

* Participate in the management of CMOs (vendors involved in manufacturing, production and quality control) and other external suppliers (vendors involved in distribution) in compliance with EU GMDP and other global requirements.

* Collaborate with production/manufacturing teams to monitor all work according to requirements under Telix quality system,

* Provide support to cross-functional team.

* Review documents assess risk and create GAP analysis based on current regulations.

* Investigate and resolve products and process problems related to quality issues.

* Ensure CAPA's and quality issues are properly documented and corrective actions taken.

* Participate in investigations of customer complaints; working with manufacturers and operations to resolution.

* Perform record reviews of batches supplied by manufacturers.

* Lead and manage quality assurance functions on-site (Telix Innovations SA). Collaborate with, provide functional leadership and support to Site team members on quality function, and support/participate in global quality initiatives (including the QMS).

* Participate in communication with the regulatory agencies as needed.

Personal development - maintain standard knowledge and make recommendations for professional development and training.

Education and Experience:

* Bachelor's degree required. Focus in pharmacy, biochemistry or science is highly preferred

* 8+ years' of experience in pharmaceutical manufacturing environment with Good Manufacturing Practices (GMP) and Good…