Position Summary:

The Associate Director, GxP Systems will report to the Sr. Director, Commercialization Systems and will be responsible for leading the implementation, validation, and support of GxP-regulated systems to enable Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a commercial biotech environment. This role will play a pivotal part in supporting regulatory, compliance, and for commercialization. Working with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M functions to ensure systems are fit-for-purpose, validated and aligned with evolving business requirements.

Responsibilities:

• Serve as the System Owner and hands-on administrator for GxP systems (e.g., TraceLink, Lorenz DocuBridge, Egnyte Life Sciences, ZenQMS, Global Vision, Veeva), overseeing system lifecycle, performance, and compliance
• Participate in system implementation activities, including vendor selection, requirements gathering, testing, and deployment to ensure alignment with business and regulatory needs
• Provide oversight and direction for Computer System Validation (CSV) activities and validation documentation, partnering with the Validation Engineer to ensure regulatory compliance and audit readiness
• Own and lead Change Control processes for all GxP systems, including impact assessments, risk evaluations, documentation, coordination of testing, and release management
• Perform system administration activities, including user access provisioning, role management, periodic access reviews, and audit trail monitoring
• Oversee system maintenance, enhancements, and issue resolution (e.g., upgrades, patches, changes), ensuring appropriate validation impact assessments, documentation updates, and minimal business disruption
• Collaborate with IT and vendors to support integration, system performance optimization, and resolution of technical issues
• Develop and maintain system-related documentation, including SOPs, Systems Inventory, administrative procedures, and work instructions in collaboration with Quality Assurance and business stakeholders
• Provide SME support during FDA audits and inspections, including preparation, documentation review, and representation of system controls and validation status
• Drive continuous improvement by identifying gaps, inefficiencies, and opportunities for system scalability and automation
• Translate business requirements into effective system solutions, acting as a key liaison between business stakeholders and technical teams
• Manage project timelines, risks, and deliverables to ensure successful and compliant execution of system initiatives

Qualifications:

• Bachelor’s degree in Life Sciences, Information Systems, Computer Science, Engineering, or a related field; advanced degree preferred
• 10-12 years of hands-on experience with GxP systems in Life Sciences, including system administration, validation oversight, and operational support
• Proven experience implementing and validating systems such as eQMS, TraceLink, LMS, Validated Documents and Data storage solutions (such as Box for GxP or Egnyte Life Sciences), or ERP systems (e.g., NetSuite, Oracle, SAP) in a GxP-regulated environment
• Strong understanding of CSV, data integrity, Part 11 compliance, and regulatory expectations (FDA, EMA, ICH)
• Experience partnering with validation/CSV resources while maintaining accountability for system compliance and validation outcomes
• Proven experience owning and managing Change Control processes for GxP systems
• Experience supporting pre-commercial biotech organizations transitioning to commercialization
• Ability to balance strategic oversight with hands-on system administration and operational responsibilities
• Strong cross-functional collaboration skills across IT, QA, Regulatory, and Technical Operations
• Experience managing vendors and implementation partners
• Excellent troubleshooting, analytical, and problem-solving skills
• Strong communication skills with the ability to translate technical concepts into business terms and influence stakeholders

Good people. Good work. Great opportunities.

McCullough Robertson is a commercially focused firm with a proud 100 year history, working with high-calibre national and international clients. We work on big matters in small teams, approaching each day with dedication and professionalism.       

We provide exceptional opportunities for our employees to perform, grow and succeed through extensive training and career development. Our teams work together and support one another to achieve individual, team and firm-wide goals.

Backed by a national team of over 400 staff located in Brisbane and Sydney, McCullough Robertson combines a century of experience with a modern, collaborative approach, making us a big firm, without the attitude.

The Role

As we build on the momentum of our centenary year and continue to support the firm’s strategic priorities, we are seeking a Business Development and Marketing Coordinator to join our Brisbane office. You will form part of the national BDM team, contributing to a strong culture of collaboration and high-performance. 

It is a fantastic opportunity for a BD & Marketing Coordinator eager to gain further experience in the legal industry in a firm that prioritises continuous improvement and genuine career development opportunities.  The role is well suited to someone who thrives in a fast-paced environment, enjoys taking ownership, and is motivated to build a career in business development and marketing within a high-performing professional services team.

Your main responsibility will involve supporting the firm’s Business Development Leads in executing practice, industry group and client strategic plans, and your day-to-day will include:

• Delivering high-quality panel and project/matter-specific tenders and credential statements (often working directly with senior lawyers and partners in their respective practice or industry groups);
• End-to-end coordination of firm, practice and client events, ensuring a seamless experience and a high standard of delivery;
• Preparing email marketing campaigns and social media posts, including developing copy in line with the firm’s key messaging, and creating relevant digital assets;
• Contributing to the firm’s strategy, including supporting various projects in involving the firm’s centenary this year, and working on innovation projects to enable data-driven decision-making and task automation;
• Assisting with the ongoing maintenance of our client relationship management (CRM) system (Dynamics 365);
• Participating in client listening initiatives, including tender debriefs;
• Preparing legal directory submissions, coordinating input and ensuring consistency, accuracy and a high-quality final product;
• Managing client and industry research and reporting;
• Assisting with management of the firm’s strategic partnerships and sponsorships;
• Assisting with internal communications, including the preparation of our monthly newsletter, and developing content for our internal social media channel.

Experience

As a successful candidate, you will hold or be working towards tertiary qualifications in a business or communications-related discipline, and have a minimum of two years’ experience as a Business Development and Marketing Assistant/Administrator.

You will be both enthusiastic and proactive, with a keen interest in engaging with a diverse range of tasks and responsibilities. 

Furthermore, you will demonstrate the following attributes:

• Excellent attention to detail;
• Strong writing, verbal communication and presentation skills;
• Strong organisational skills, including the ability to prioritise workflow, follow procedures, and communicate progress effectively;
• Prior experience working with stakeholders at varying levels, with a collaborative and service-orientated approach;
• A hands-on, proactive and collaborative working style;
• Flexibility to undertake a range of tasks while appropriately managing priorities and deadlines;
• An interest in continuous learning and process improvement;
• Sound judgment and professionalism to deal with sensitive and confidential information.

Benefits

At McCullough Robertson, we encourage a balanced work environment. Our teams enjoy having the opportunity to work in a supportive environment while having fun and achieving results.

We offer the following benefits for our employees:

• Dedicated diversity committee with an innovative program focusing on all areas of diversity and inclusion;
• Attractive further education program and supportive learning and development opportunities throughout your whole career;
• Mentoring and sponsorship opportunities as well coaching and leadership support;
• Holistic health and wellbeing program including subsidised gym membership and active social and sporting committees; and
• End-of-trip facilities.

Inclusion and Diversity

We are a leader in diversity and inclusion and are committed to creating an inclusive environment for all employees.

Our commitment is to create an accessible, inclusive and informed workplace, where we can collectively make a difference for everyone, including people with disability, to gain equal opportunities and grow their career at McR. This is our commitment to diversity and inclusion and how we bring to life our McR values.

An award-winning law firm, we have received the prestigious Employer of Choice for Gender Equality citation for the tenth consecutive year and have recently been awarded by Lawyers Weekly – Diversity Law Firm of the Year.

To apply for this position, please click on the "Apply for Job" button, and submit your application online. Alternatively, please contact Sophie Sims on 07 3914 8462 for a confidential discussion.

We're an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.