Quality Consultant - Cryopreservation

Date: 25 Jun 2025

Site: VCCC (Parkville)

Location:

MELBOURNE, VIC, AU, 3000

Company: Peter MacCallum Cancer Centre

Unit: Cryopreservation

Division: Chief Operating Officer

Department: Haematology Operations

Enterprise Agreement: Health and Allied Services, Managers and Administr

Cryopreservation

At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting and retaining top talent and providing the best possible cancer care for our patients.

YOUR ROLE IN OUR FUTURE

Quality Consultant – Cryopreservation

Ongoing, Part-Time position
0.63 EFT or 48 hours per fortnight

The quality consultant within Cryopreservation is responsible for ensuring the highest standards of quality assurance, regulatory compliance, and patient safety across all quality activities within the Cryopreservation unit and other related departments within Ambulatory Cell Therapies (ACT).
The successful candidate will lead the development, implementation, and continuous improvement of quality management systems to ensure regulatory compliance and that Cryopreservation practices align with the highest standards of safety, efficacy, and clinical care for patients.

The ideal candidate will meet the following essential requirements:

Qualification in Medical Science, Health Science or relevant discipline
Recognised scientific training and competence relevant to the position including knowledge in cell therapy/cryopreservation, analytical methods
Proficient with information systems (MS Word, Excel, Outlook, Access, LIMS and Explorer/Netscape).
Experience and expertise with the use of Quality Management systems (Such as Q-pulse or master control)
Experience in document preparation, report writing, risk mitigation and non- conformance management
Proven experience in training and education of staff
Excellent communication, interpersonal and team building skills
Understanding and / or leadership experience to sustain departmental compliance in the delivery of safe patient services within a highly regulated environment

Our benefits

We offer a range of benefits which support our people both personally and professionally, including:

Up to $11,660 in salary packaging to increase your take home pay
Discounted health insurance and eye care
A comprehensive health and wellbeing program
Public transport options at our doorstep and end of trip facilities for cyclists
Onsite eateries and coffee shops and inviting rooftop garden spaces
Pathways for professional development and new career opportunities
Five weeks annual leave (pro-rata), 17.5% leave loading and purchased leave options
Flexible, hybrid working practices

Join us!

If you feel this role is right for you, we warmly invite you to apply and encourage your early application. All appointments are made subject to a satisfactory police check and may include vaccination requirements. Should you need assistance or require any adjustments or accommodations to fully participate in the application or interview process, you are welcome to reach out to the contact person listed. We acknowledge that not all applicants will meet the full list of selection criteria outlined, and wherever possible we will consider applications where relevant experience can apply.

Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.
For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.

Hiring Manager: Janu Davawala
Contact Number: 03 8559 7360
Email: Janu.Davawala@petermac.org

Applications Close: 16 July 2025

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Position Summary

Responsible for ensuring the highest standards of quality assurance, regulatory compliance, and patient safety across all quality activities within the Cryopreservation unit and other related departments within Ambulatory Cell Therapies (ACT). This position plays a critical role in coordinating and maintaining quality activities to meet the objective of Clinical Haematology while adhering to regulatory requirements. The Cryopreservation department is currently Accredited by TGA (Therapeutic Good Administration) and NATA (National Association of Testing Authorities) and will working towards obtaining FACT (Foundation for the Accreditation of Cellular Therapy) accreditation.

The Cryopreservation Quality Consultant will lead the development, implementation, and continuous improvement of quality management systems to ensure regulatory compliance and that Cryopreservation practices align with the highest standards of safety, efficacy, and clinical care for patients. With a focus on quality and risk mitigation, this position is pivotal in ensuring the department's operations are streamlined, efficient, and patient-centred.

Enterprise Agreement

Health and Allied Services, Managers and Adminstrative Workers

Classification or Salary Range

Grade 5: HS5

Immunisation Risk Category

Immunisation Risk Category A

Key Relationships

Internal	All members of Ambulatory Cell Therapies Clinical Haematology Pathology department Centre Of Excellence in Cellular Immunotherapy Parkville Cancer Clinical Trials Unit team members Other health professionals
External	Cell Therapies Pty Ltd Clinical Quality Manager Any external stakeholders that relate to patient care activities within ACT (e.g. Clinical Trial sponsors and clients for standard of care programs) External companies that provide equipment, consumables and services.

Education

Skills

Essential Requirements

Qualification in Medical Science, Health Science or relevant discipline
Recognised scientific training and competence relevant to the position including knowledge in cell therapy/cryopreservation, analytical methods
Proficient with information systems (MS Word, Excel, Outlook, Access, LIMS and Explorer/Netscape).
Experience and expertise with the use of Quality Management systems (Such as Q-pulse or master control)
Experience in document preparation, report writing, risk mitigation and non- conformance management
Proven experience in training and education of staff
Excellent communication, interpersonal and team building skills
Understanding and / or leadership experience to sustain departmental compliance in the delivery of safe patient services within a highly regulated environment

Desireable Requirements

Experience in delivering a cGMP, NPAAC or FACT compliant Cryopreservation service
Understanding/knowledge of Apheresis and/or Cellular Therapy
Demonstrated Quality improvement initiatives/experience
Understanding of haematology and medical microbiology

Certifications, Licenses & Registrations

Key Accountabilities

Key Accountabilities	Demonstrated By / Key Performance Indicators
1. Regulatory and Operational Compliance	Collaborate with key stakeholders to plan and coordinate service delivery, workflow, and resource allocation. Oversee compliance across all Cryopreservation processes, including standard of care and clinical trial programs, external partnerships, and new program onboarding. Ensure regulatory adherence in cell product handling, transport, processing, storage, shipment, materials use, environmental monitoring, facility standards, and competency assessments. Participate in planning, execution and managing validation activities, monitoring ongoing compliance. Track and report on key performance indicators to maintain service effectiveness. Support adoption of new technologies and services. Identify, escalate, and manage risks with leadership, implementing controls as needed. Provide scientific expertise to maintain regulatory and clinical standards.
2. Equipment Management and Compliance	Participate in procurement, testing, and validation of equipment and consumables, ensuring patient safety and regulatory compliance. Coordinate documentation for equipment management within regulatory frameworks. Ensure all equipment is fit for purpose and covered by appropriate maintenance contracts where applicable. Assist ACT departments in planning and executing equipment validations. Maintain communication with Clinical Quality and ACT representatives to uphold ongoing compliance. Oversee commissioning, validation, decommissioning, calibration, and maintenance activities with Senior Scientists, ensuring timely execution and documentation.

Key Accountabilities (Contd..)

3. Quality Management and Continuous Improvement

Participate in internal and external quality assurance programs, non-conformance reporting, and audit preparation.
Support hospital accreditation activities and manage audit responses and closeouts.
Conduct regular unit audits to ensure ongoing compliance.
Lead investigation and resolution of non-conformances and CAPAs, ensuring timely closure.
Perform Risk assessment and gap assessment where relevant to ensure regulatory compliance is met
Escalate issues to management and quality nominees as appropriate.
Identify areas for process improvement to mitigate risks proactively.
Participate in product/process reviews and staff education on risk mitigation.
Generate and present reports on quality metrics at clinical and multidisciplinary meetings.
Adhere to and promote PMCC and ACT quality systems and policies.
Coordinate, development, review and management of SOPs, policies, validation protocols, reports, and change control documentation for Cryopreservation.
Ensure document accuracy and currency, including agreements related to departmental operations.

4. Team Collaboration, Support and Development

Model and foster a culture of respect, excellence, compassion, and innovation across the unit.
Translate organisational standards and policies into actionable practice throughout the Cryopreservation department.
Support departmental operations through after-hours, overtime, and on-call contributions as required.
Collaborate with the Cryopreservation Manager and ACT medical lead on recruitment, workforce planning, and staff onboarding.
Provide training and education to staff on regulatory compliance, quality standards, and updates following non-conformance incidents or process changes.
Maintain oversight of staff competency levels and ensure accurate, up-to-date training records.
Encourage professional growth through participation in educational courses, clinical/scientific meetings, and conferences.
Support skills development, innovation, and continuous improvement within the team.
Represent the Cryopreservation department at internal and external scientific meetings, seminars, and professional forums.
Actively promote the work and reputation of PMCC through professional and academic engagements.
Contribute to and support broader departmental initiatives and interdepartmental collaboration.

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For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position profile. Alternatively, please contact us for a confidential discussion.

Peter Mac is a child safe organisation and has a commitment to child safety and wellbeing.

WHY WORK FOR PETER MAC

Peter Mac offer a range of benefits which support our people both personally and professionally.
Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.
We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.