Quality Manager

We have an exciting opportunity for a **Quality Manager** to join our growing team

Nucleus Network is the only global Phase 1 clinical trial specialist with facilities in the USA and Australia, fulfilling our purpose of _"advancing medicine and improving lives",_ by attracting the best talent.

Since our establishment in 2004, Nucleus Network has conducted well over 1000 Phase 1 clinical trials for biotechnology and pharmaceutical companies from the USA, Europe, Australia, Japan, South Korea, Taiwan and China.

Come and join us through this exciting journey of expansion and gain world-class experience servicing some of the most innovative biotechnology and pharmaceutical companies globally.

**About the Role**

To provide Quality operational support to functional teams and assist in the management of the Nucleus Network Quality System for the purpose of support Trial Realisation activities across all NN departments.

**Key responsibilities**
- Provide on-the-floor support to operations functional areas to ensure consistency, reliability and data integrity
- Managing site deviation and CAPA processes by providing rapid response support to teams when problems are identified
- Performing labels and batch Quality release
- Change control, risk management and archiving support
- Supporting documentation quality control practices throughout operations by identifying key trends and working with operations teams to improve processes and documentation integrity
- Conducting internal audits of functions, processes and clinical studies
- Maintaining equipment through oversight of maintenance, calibration, and validation activities
- Participating in the creation, management, and improvement of clinical study templates
- Participation in site initiation visits, clinical study protocol reviews, and study safety reviews, as necessary
- Developing training material and delivering site-based training (as necessary)

**Requirements**:

- A Bachelor of Science in relevant quality/technical discipline
- 2 to 5 years of experience in Quality, or related field in the medical clinical/ Pharma industry (Desired)
- Practical knowledge and experience in GXP Quality Systems/ISO9000
- Personnel management or functional area leadership experience
- Ability to implement and improve process efficiency
- Support learning and development team with training documentation
- Good practical knowledge of global Good Clinical Practice (GCP) requirements and/or GMP.
- Experience with Quality System Documentation and Good Documentation Practices.
- Previous experience in the Pharmaceutical / Life Science TGA/FDA regulated industry

**Benefits**
- Make a difference in _'Advancing medicine, improving lives'_
- We offer career development pathways and LinkedIn Learning to further your skills and education
- Employees are recognized through our Reward and Recognition Program and have access to a range of discounts with online and in store retailers
- At Nucleus Network we are committed to creating a supportive and inclusive space where every individual feels they can be their full selves. Our policy applies to all aspects of employment, including our hiring and selection process. We are an equal opportunity employer; seeking people from all life stages, backgrounds and life perspectives. Our focus are people who embody our values of drive, teamwork, customer focus and excellence._
- At Nucleus Network, we recognize our responsibility to ensure the safety of our staff, participants, and visitors. As such, Nucleus Network requires all employees to be vaccinated against COVID-19. Vaccination evidence must be provided before the commencement date._

**Job Types**: Full-time, Permanent

**Benefits**:

- Professional development assistance
- Referral program

Schedule:

- Flexible hours

Work Location: One location