Quality Manager

Come and Save Lives with Us!

SERB Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases.  We have over 470 employees in 16 countries and a group revenue in excess of €350m.

Our portfolio 80+ rescue medicines make a real difference in the lives of patients and their caregivers and that gives every one of our employees a sense of purpose.

Our Purpose is supported by our 4 key values:

• We make patients our priority
• We act with integrity and accountability        
• We work together as one team         
• We look for better ways forward       

Broad Function
As the Quality Manager, will work with the Site Director as part of the Australian Leadership Team (ALT) to translate the Company's vision and quality objectives into local strategy.  You will manage the Quality team to deliver agreed production output to the supply chain and work to the required cost, quality and time targets.  Lead the local implementation, development and improvement of the Company's Quality Management System (QMS).
Principle Responsibilities

• Ensure that validation activities, calibrations and maintenance of equipment are performed in line with Site Validation Master Plan
• Conduct GMP/GDP audits internally and externally to ensure compliance with TGA and FDA and any other relevant Regulatory Authority
• Continuously review key quality parameters through the CAPA process to drive the  continuous improvement in Quality standards
• Ensure there is a system for storage of batch reference samples as required by regulatory authorities 
• Ensure Certificates of Analysis are generated and filed for each batch of serum released  Ensure that deviations, nonconformances and out-of-specification results are investigated, assessed and managed via the Company's QMS.
• To be the first point of contact for regulatory bodies such as the TGA, FDA and any other appropriate regulatory authority at time of inspection
• Review from a Quality perspective, the effective operation of the livestock health management program 
• Be able to identify and change procedures which are inconsistent or unworkable with the guidance of the Department Manager and in relation to TGA compliance
• Provide global QMS and support for interstate and overseas audits for non-Australian suppliers as required

Education and Experience
•    A Degree or equivalent in a scientific discipline such as Chemistry, Biochemistry, Microbiology, Immunology, Pharmacy or Life Science
•    Previous experience in a senior quality role, preferably in a manufacturing background
•    Educational background should be supported by at least  years' experience in an appropriate Quality role within the Pharmaceutical / Biotechnology industry
•    In depth knowledge of cGMP and ability to conduct internal and external GMP/GDP audits.

Skills and Attributes
•    Ability to work with employees at all levels of seniority utilising excellent communication skills, both on an internal and external basis
•    Competent, methodical, highly organised individual who pays strict attention to detail and has the ability to effectively prioritise and execute tasks accurately within a high-pressure environment.
•    Creative thinker able to solve problems, question the status quo and consider innovative solutions to complex issues
•    Must be able to work as part of a collaborative team and demonstrate initiative when required with a flexible and willing attitude at all times
•    Highly self-motivated and directed

Serb Pharmaceuticals is an equal opportunity employer. We offer competitive compensation & benefit packages, challenging opportunities and a culture of working together in a supportive way built on our strong foundation of values.