Position Summary:

ultrafocused – Work together to fearlessly uncover new possibilities

The Senior Manager, CMC QA will be responsible for the Product Complaints, Annual Product Quality Review and CMC Change Control Review Board programs and will maintain strategic responsibility over QA Manufacturing Operations and will implement and communicate Ultragenyx’s CMC quality approach for the company. This role will direct and oversee operations in accordance with GxP regulations and Ultragenyx standards. 

Work Model: 

Flex: This role will typically require onsite work 2-3 days each week, or more depending on business needs. In many locations, the business will set certain days each week that Flex employees are required to be onsite.

Responsibilities:

1. Facilitate Global Annual Product Review/Product Quality Review in partnership with Quality Leads and collaboration with Tech Ops and Reg CMC 
2. Lead UGX Change Control Review Board program and provide coaching to Change Owners on the Change Control process as needed 
3. Support the release of production lots in accordance with Ultragenyx procedures 
4. Execution of Quality Systems in an Owner/SME or QA role, for Deviations, Change Controls and Product Quality Complaints 
5. Lead and actively participate in Continuous Improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by the CMC QA and cross-functional partners 
6. Design, develop, and review CMC QA standards and procedures (i.e., policy documents and SOPs). Review and support deployment of Quality Standards generated by the Quality System Department 
7. Support the Product Complaints function in investigating reported product quality events, as needed 
8. Represent Ultragenyx to Health Authorities during inspections 
9. Ensure activities and deliverables comply with FDA, EMA and local regulations and guidance, ICH guidelines, Ultragenyx policies, SOPs and industry best practices. 
10. Communicate and promote a culture of quality and operational excellence  
11. Other duties as assigned 

Requirements:

1. A Bachelor’s degree or equivalent work experience in QA Manufacturing Operations or related discipline.  
2. 8+ years of experience in a GMP biopharmaceutical manufacturing environment in technical operations and/or quality. 
3. Experience with management of Change Control process and Review Board. 
4. Experience with Product Disposition.  
5. Demonstrate quality mindset and influences across the entire organization. 
6. Strong understanding unique quality and manufacturing expectations from other regulatory authorities such as EMA, ANVISA, MHRA, etc. 
7. Expert knowledge of GMPs. 
8. Flexibility and the ability to manage change. 
9. Strong interpersonal skills and the ability to work well as part of a team. 
10. Demonstrated ability for analytical and systematic thinking. 
11. Experience with Product Complaint handling, investigations, and reporting a plus. 
12. Fosters an environment of accountability, diversity and speaking up. 
13. Demonstrated high personal and professional ethical standards. 
14. Travel up to 10% of total work hours.  

#LI-CT1 #LI-Hybrid

As part of the Fever Originals team, you will use data and insights to create one-of-a-kind events and experiences that allow people to have unforgettable moments. 

ABOUT THE ROLE

We are looking for an experienced, passionate, and critical-thinking event producer who will support our Executive Producer and Project Manager in all aspects of production ensuring that high-quality experiences are delivered. This person will serve as the point of contact on the production side of all projects, being responsible for the third parties involved in the execution, development, and production of the creative deliverables.

To support the development of new events, the Producer will research and periodically support the implementation of new production formats, technologies, and solutions that could enhance Fever’s experiences.

This role requires flexibility, creativity, attention to detail, and the ability to meet deadlines while staying within budget. The ideal candidate has a proven track record in live event production and experiential marketing.

Candidates should be passionate about delivering results and producing fun and entertaining experiences for all walks of the public. Strong communication skills are critical to success in this role. The right candidate will be a self-starter and have strong interpersonal and project management skills.

Employees are expected to be in the office Monday to Thursday with possibility to work from home on Fridays.

This is a temporary maternity cover contract (12 months).

You will:

• Manage all aspects of events production, including pre-production logistics planning, vendor selection, hiring, onsite execution, as well as post-event wrap-up
• Create production timelines and ensure that teams are keeping to schedule
• Communicate and collaborate with Project Managers and on-site teams to drive alignment and execution of concerts
• Optimize production costs and processes whenever possible
• Manage thorough follow-up of third parties' quotes, invoices and P&L updates
• Secure proper event permits and meet insurance requirements
• Venue research and booking
• Secure proper event permits and meet insurance requirements
• Handle administrative duties including expense reports, invoicing, and working with the legal department on contracts 
• Domestic and international travel and work across time zones may be required 

QUALIFICATIONS

You have a track record of successfully produced events with strong data analysis, oral and written communication skills. You thrive in a fast-paced environment and pride yourself on your flexible, detailed, analytical mindset.

The role requires a mix of business development and operational experience. Candidates need to be passionate about the entertainment/events industry. You will have to be comfortable delivering results in an ambiguous environment, being exceptionally detail-orientated while looking around corners, and thinking bigger about how we create a compelling experience. 

• 4+ years of experience in the event production industry
• Native/Fluent level of English. Other languages a plus.
• Ability to manage multiple projects at any given time and pull together multiple aspects of an event in an organized and efficient way
• Have an innovative mindset to identify cutting edge solutions in the production space
• Have a strong network of vendors and venues 
• Understanding of technical production requirements 
• Basic knowledge of fabrication processes  and familiarity with permitting processes  
• Huge appetite for learning and the ability to pick up new skills quickly
• You'll be solution-focused, identifying problem areas and then creating plans to find resolutions 
• Have strong communication skills and a proven track record of building positive working relationships
• Curious and keen to push boundaries and try new concepts
• Able to communicate with partners, brands, agencies, and talent on efforts
• Ability to think strategically when faced with an events partnership brief or with our proprietary data on what events work
• Collaborative and willing to get hands dirty
• Knowledge of promotional tools such as Facebook and Instagram is a plus

You can expect to join a group of diverse, hardworking team players, where a cultural fit is someone willing to stay humble and learn and can work nimbly. We welcome applications with unusual backgrounds with the expectation that the applicant will have acquired hard or soft skills and maturity throughout their experiences.

BENEFITS

• Attractive compensation package and the potential to earn a significant bonus for top performance.
• Opportunity to have a real impact in a high-growth global category leader
• 40% discount on all Fever events and experiences
• Private health insurance
• Work in the heart of the city, with possible travel across our markets
• Responsibility from day one and professional and personal growth
• Great work environment with a young, international team of talented people to work with!

Our hiring process

• A 30 min video call with one of our Talent Acquisition Managers, to better understand your career plan, assess cultural fit, and answer any questions you may have
• A 60 min online test with three topics: logic, analytics, and written understanding
• A 30 min interview with your future manager
• A 45 min video call with your future manager, including questions about your profile.

On average our process lasts 20 working days and offers usually follow within a week.

#LI-Remote

Good people. Good work. Great opportunities.

McCullough Robertson is a commercially focused firm, 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, Sydney, and Canberra, McCullough Robertson is a big firm, without the attitude.

The Role

Are you a seasoned employment lawyer, wanting to work in a large, busy team, ready to elevate your career?

This role offers an exciting opportunity to work within our high-performing Employment Relations and Safety team in Brisbane, and to contribute significantly to our State Government practice. You will play a pivotal role in shaping workplace policy and employee relations strategies for public sector entities while driving impactful solutions that make a difference for the team’s clients generally.

Collaborating closely with partner, Lydia Daly, but also working with the team’s other three partners, your work will include:

• Advising clients on disciplinary processes and effective workforce management strategies tailored to the public sector IR framework;
• Advocating for clients within various tribunals;
• Managing matters including applications for reinstatement, general protections, discrimination, industrial disputes and appeals;
• Conducting or managing investigations into allegations involving misconduct, corruption and code of conduct breaches;
• Preparing show cause letters and decisions in discipline matters, and responses for employee grievances;
• Developing and delivering training and presentations to clients and industry events on essential areas, such as bullying, sexual harassment and workplace health and safety;
• Providing advice to client’s executive teams, HR and legal teams on performance management and dismissal processes, ill and injured employees, industrial instrument interpretation, liability for unpaid wages and entitlements, and other industrial relations matters.

Experience

As the successful candidate, you will be an accomplished lawyer with 5+ years PAE. You will have experience in both the federal and Qld IR frameworks, with a particular focus on representing State government and local government clients. Your passion for specialising in this field will be evident by your wealth of expertise and strong commitment to advancement in this space.

You will also possess outstanding technical legal skills, exceptional communication abilities, and an eye for detail that ensures precision in all aspects of your work.  Your values must align with those of the firm.

As a senior member of the team, you will have a key mentoring role, guiding and developing junior lawyers to enhance their skills and thrive in the complex world of employment law. Your leadership and support will be integral in fostering the growth and success of the team.

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 as coaching and leadership support;
• Holistic Health and Wellbeing program including subsidised gym membership and active social and sporting committees; and
• In-house barista and end-of-trip facilities.

Inclusion and Diversity 

We are a leader in diversity and inclusion and are committed to creating an environment where our employees want to come to work.

Our commitment is to create an accessible 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.

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 Team

Our Employment Relations and Safety team delivers tailored, commercial solutions to complex workplace issues. Supporting organisations across the full employment lifecycle, we provide comprehensive guidance on workplace compliance, investigations, restructuring and change management, industrial relations and employment litigation, enterprise bargaining, dispute resolution, executive exits and post-employment enforcement. Additionally, our Work Health and Safety practice combines in-depth knowledge of WHS issues and legislation with genuine commitment to clients, approaching each matter with confidence and care.

The Role

McCullough Robertson’s Employment Relations and Safety practice is entering an exciting phase of national growth, and we are seeking exceptional talent to join our expanding Brisbane team.

In this role, you will work closely with both private and public sector clients across a broad spectrum of employment and industrial relations matters. You will provide strategic, commercially focused advice and representation on complex workplace issues, supporting organisations to navigate evolving legislation, manage risk and achieve practical, compliant outcomes.

As part of a highly regarded and collaborative team, you will contribute to meaningful, high-impact work that shapes workplace practices across diverse industries. This is a rare opportunity to work alongside respected leaders in the field, deepen your expertise in complex and sensitive matters, and play a genuine role in delivering forward-thinking solutions that support positive and productive workplace cultures.

Experience

We are seeking a driven and capable lawyer with three to four years of post-admission experience and a demonstrated commitment to employment and industrial relations law. The successful candidate will have a strong track record providing front-end employment advice and undertaking detailed document reviews, as well as managing back-end litigation in courts and tribunals. Experience acting for government clients at the federal, state or local level, together with an understanding of national-system employers, will be highly regarded however, we welcome applications from practitioners with experience across either the federal or state industrial relations frameworks.

As the successful candidate, you will bring excellent written and verbal communication skills, coupled with a proactive, outcomes-focused approach to client service. Confidence in building meaningful relationships with clients and colleagues is essential, as is the ability to manage competing priorities with efficiency, sound judgment and professionalism. We are looking for someone who thrives in a collaborative team environment while also being capable of working autonomously when required. Furthermore, you will have a genuine passion for employment law and a desire to build a long-term career in this dynamic and evolving area of practice.

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 as coaching and leadership support;
• Holistic Health and Wellbeing program including subsidised gym membership and active social and sporting committees; and
• In-house barista and end-of-trip facilities.

Inclusion and Diversity 

We are a leader in diversity and inclusion and are committed to creating an environment where our employees want to come to work.

Our commitment is to create an accessible 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.

Good people. Good work. Great opportunities.

McCullough Robertson is a commercially focused firm, 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 is a big firm, without the attitude.

The Team

McCullough Robertson’s Insurance and Corporate Risk group stands out as a leader in the Australian legal market. We offer advice across every class of insurance including public and product liability, ISR, contract works, property, professional indemnity, D&O, workers' compensation, marine, and aviation.

Our team is comprised of highly skilled and approachable professionals who thrive in a friendly, collaborative and high-performing environment. With a wealth of expertise, we are dedicated to delivering tailored solutions that meet the unique needs of our clients.

The Role

Due to our success in building the practice and an increased volume of work, we are actively recruiting for a mid to senior level lawyer to join our high-performing practice. As a key member of the team, you will collaborate closely with our partners and have the chance to play a role in the management of client relationships and team development.

Working in this role, your primary focus will be acting for defendants in personal injury claims, particularly in the area of abuse claims, but also in other commercial sectors. You will also work across an array of other legal matters including public liability, workers compensation appeals, property damage, policy interpretation, coverage litigation, and general insurance and contractual matters. You will have the opportunity to develop close relationships with your clients which include key players in construction, resources, agribusiness, property ownership, not-for-profit, technology, and infrastructure, and to refine your business development skills.

If you are passionate about advancing your legal career in the insurance sector, this is the ideal opportunity to make a significant impact and grow in a supportive, high-calibre environment.  The two partners leading this team are committed to helping the successful candidate to develop their career.

Experience

As the successful candidate, you will be a driven and technically excellent mid to senior level lawyer with a minimum of three years post-admission experience. You will have a passion for insurance law and a clear ambition to advance your career in this field. A background in personal injury claims is essential, particularly within the defendant space, however we are also open to hearing from candidates with experience in plaintiff work eager to make the transition.

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 as coaching and leadership support;
• Holistic Health and Wellbeing program including subsidised gym membership and active social and sporting committees; and
• In-house barista and end-of-trip facilities.

Inclusion and Diversity

We are a leader in diversity and inclusion and are committed to creating an environment where our employees want to come to work.

Our commitment is to create an accessible 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.