Validation Manager

3 days ago

Sydney, Australia Proclinical Full time

Proclinical has partnered with an Australian based company that is committed to enhancing patient care and outcomes by developing ground-breaking diagnostic technologies. They are currently developing and commercialising a patented molecular diagnostic platform, that provides hospitals and pathology labs with the ability to screen for a wide array of infectious pathogens with a high degree of specificity in a rapid throughput environment.

**Tasks and responsibilities**

The position of Validation Manager will lead a well-established competent team of 10 people, in the performance of studies for domestic and international regulatory submissions, enabling the business to bring their innovative molecular diagnostics technology to market. As well as responsibility and oversight of the following;
- Authority to draft validation protocols, and plan who, how and when to perform validation studies
- Make decisions on troubleshooting, approach to analytical/clinical validation studies and variables
- Draft analytical validation and stability protocols in collaboration with Regulatory Affairs team
- Draft clinical validation protocols in collaboration with Regulatory Affairs team
- Assist Validation Scientists to perform analytical studies for new nucleic acid extraction kits and real-time PCR assays
- Assist with some aspects of process, equipment and computer software validation
- Analyse data and assist with problem solving and experimental design
- Prepare validation and clinical trial reports in collaboration with Regulatory Affairs team
- Performance of the product validation studies
- Record all details of product evaluations
- Perform controlled validation experiments (e.g., specificity, sensitivity and stability studies)
- Manufacturing and validation documentation authorship and approval responsibilities
- Comply with regulatory requirements (including TGA, HC, FDA and IVDR)
- Assist with CAPA investigations
- Liaise with Regulatory Affairs Manager to ensure all activities comply with QMS and regulatory requirements
- Maintain of appropriate safety, record keeping and quality requirements

**Qualifications and experience**

To be considered for this position, you will need the following skills, experience, knowledge, and attributes.
- Scientific background with a Bachelor of Science or Biomedical Science, a Masters or a PhD is desirable
- Experience in Product, Process or Equipment Validation of medical devices to FDA regulations
- Experience with Molecular biology products including real time PCR
- A strong understanding of the molecular diagnostics field and relevant international regulations
- Experience in leading and managing a team of highly educated professionals

**Benefits**
- Sponsorship and relocation to Australia
- Attractive remuneration package that includes a long term incentive scheme
- Ability to work from home and have flexibility around start and finish times
- Work close to a thriving vibrant café and restaurants seen

Please be advised before applying, that is role is located in Australia, and you would need to relocated. The business will of course provide sponsorship and a relocation package

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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