Associate Director, Quality Control

6 months ago

Melbourne, Australia Moderna Full time

**The Role**:
Moderna is on the lookout for a dynamic, motivated, and dedicated professional to serve as the Associate Director for Quality Control at our new manufacturing site in Australia. The individual in this role will directly oversee commercial testing functions in the Quality Control department in support of raw materials and drug substances testing for mRNA products produced at Moderna’s manufacturing facility and affiliated contract organizations (this will include Microbiological and EM tests as well). Also, this individual may support related method transfer, qualification and validation activities and assist in the development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements. He/she will also manage a group of laboratory personnel and oversee performance management, mentoring and career development. The individual will act as interdepartmental liaison to various groups including AS&T, Global QC, External QC, Quality Assurance and Regulatory.

**Here's What You’ll Do**:
Oversees day-to-day operations of the Quality Control commercial program testing functions, including stability.

Ensure on time delivering of tests results and proper support of deviations.

Work with a Lean mindset and suggest any change that can improve the efficiency.

Manages laboratory personnel and oversees their selection, performance management, mentoring, and career development.

Assists in development of appropriate Standard Operating Procedures, laboratory data collection & documentation systems (paper and electronic) and training of personnel to ensure cGMP compliance.

Supports laboratory investigations, change controls, and CAPAs for relevant QC operations.

Contributes to budget planning and resource allocation.

Provide testing data and other required quality-related information needed to support product studies.

Interacts with AS&T, Quality Assurance, Regulatory Affairs, and other Departments to:
Support testing for drug substance and drug product internally and at CMOs and contract laboratories.

Provide testing data and other required quality-related information needed to support stability programs, APQR.

Collaborates/Supports with AS&T and development groups for method transfer and qualification activities as required.

Assists in development, implementation, and maintenance of general laboratory operational QC/IT systems in accordance with cGMP requirements.

Interface with health authorities to support site and external inspections as required.

Troubleshoots issues related to laboratory procedures and assay performance.

Provides support to audit teams for Health authority, Internal/External and vendor audits.

Ensures teams perform tasks as needed to maintain GMP compliance

Evaluate, align, and oversee QC data analytics, monitoring, and trending (e.g., method and product performance trending).

Works with Digital/IT to continually strengthen data integrity across the QC testing laboratories.

**Here’s What You’ll Bring to the Table**:
**Minimum education required**: Bachelor’s Degree in a relevant scientific discipline.

**Minimum experience required**: 10 + years in applied industry experience; 4-6 years of management/supervisory experience.

Demonstrated proficiency with Quality System Records, Deviations, Change Controls and CAPAs.

Previous supervisory experience is preferred, including testing scheduling and lab project management.

**Minimum knowledge required**: general laboratory operations, method acquisition, qualification.

**Minimum skills required**:
Technical writing.

Proficiency with Microsoft Office Programs.

Familiarity with electronic databases (e.g., LIMS, SAP, LMS).

Familiarity with QC operations including bioassay, chemistry, and microbiology.

HPLC Instrumentation/ Software experience is preferred.

Strong written and oral communication skills as well as organizational skills.

Knowledge of industry standards and guidelines, experience supporting compliance audits.

Demonstrated ability to work effectively under established guidelines and instructions.

Ability to collaborate effectively in a dynamic, cross-functional matrix environment.

Working knowledge of relevant and current FDA, EU, ICH guidelines and regulations.

Ability to efficiently prioritize and complete multiple projects and tasks in a fast-paced environment.

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end

  • Associate Director, Quality Control

    6 months ago

    Melbourne, Australia Moderna Full time

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners...

  • Associate Director, Divisional Controls

    2 months ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Permanent Full time **Region**: VIC- Melbourne CBD **Associate Director, Divisional Controls (Fraud Operations)** Support our amazing Fraud Operations (FO) and Financial Crime Operations (FCO) teams by assisting first-line business owners in identifying and managing risks, enhancing processes, and addressing issues or events that affect both...

  • Associate Director, Controls

    4 weeks ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Permanent Full time **Region**: VIC- Melbourne CBD - **Seeking experienced Audit / Assurance / Risk professionals to join the team based in Melbourne.**: - **Play a pivotal role in improving NAB’s risk and control environment and contribute to NAB achieving its strategic priorities.**: - **We are empowered to make a positive difference in...

  • Associate Director Divisional Controls

    7 months ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Permanent Full time **Region**: VIC- Melbourne CBD - **Bring your passion for divisional controls alongside your experience in first line controls compliance**: - **Make a genuine difference through the work you do**: - **Bring your ideas, ambitions, and passions both in and outside of work** **It’s more than a career at NAB. It’s about...

  • Quality Assurance Associate

    6 months ago

    Melbourne, Australia Canopy Growth Corporation Full time

    The Company At Canopy Growth, our mission is clear: improve lives, end cannabis prohibition, and strengthen communities. We believe that cannabis can be a force for good. We’re building a consumer-centric organization that is focused on sharing the transformational potential of cannabis with the world. We will achieve this through an innovative and...

  • Associate Director, Assets

    1 month ago

    Melbourne, Australia Department of Transport and Planning Full time

    Location: Melbourne | Parkville Job type: Ongoing - Full Time Organisation: Department of Transport and Planning **Salary**: $182,813 - $248,629 Occupation: Other Reference: 6053 **About the Role** The Associate Director Assets will adopt a risk-based strategic approach to lead the management of the department’s tram assets, including new tram...

  • Associate Director

    8 months ago

    Melbourne, Australia Clemenger Group Full time

    Who we are Hall & Partners is a team of unconventional thinkers, obsessed with how marketing influences the relationship between people, brands, and culture. Born out of adland, we are the insight agency known for weaving creativity with science. Our strength is our diversity and flexibility, we're focussed on solving the difficult problems our clients are...

  • Quality Assurance/control Technician

    6 months ago

    Melbourne, Australia Programmed Full time

    Programmed Skilled Workforce is a leading provider of managed workforce and training services. Our Client, a leading manufacturer of power transmission products, has an exciting opportunity for a Quality Control Technician to join their team near Clayton VIC. This role is day shift, Monday - Friday 6:00am - 2:30pm. Programmed Skilled Workforce is a leading...

  • Associate Director, Divisional Controls

    2 months ago

    Melbourne, Australia NAB - National Australia Bank Full time

    **Work type**: Permanent Full time **Region**: VIC- Melbourne CBD - **We’re leveraging our size to do positive things for customers.**: - **Experience exciting momentum with support from awesome leaders.**: - **When you’re ready for a bigger challenge, you’ll get the tools and support to succeed.** **In this Associate Director role, you will**: -...

  • Associate Director Network Resilience

    1 month ago

    Melbourne, Australia Department of Transport and Planning Full time

    Location: Melbourne | Parkville Job type: Ongoing - Full Time Organisation: Department of Transport and Planning **Salary**: $182,813 - $248,629 Occupation: Other Reference: 5910 **About the Role** The Associate Director Network Resilience is a crucial leadership role that actively oversees a highly skilled operational team focused on achieving a...

  • Associate Director

    6 months ago

    Melbourne, Australia HR GO Recruitment Full time

    **Associate Director - Asset Management**: **Victoria - Melbourne** **up to $160000 per annum, Super + Bonus** **Permanent** Surveying - Job Reference - 270815 Associate Director - Asset Management Melbourne Salary up to $160,000 p.a. (negotiable) + Super + Bonus Hybrid working Are you looking for a strategic role at Associate Director level in Asset...

  • Quality Assurance Compliance Associate

    6 months ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation - Quality & Document experience - Melbourne Metro Area **About the Company**: Operating as a major global Multinational manufacturing organisation, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace, offering a range of healthcare products to local & global...

  • Associate Director, Contract Management

    1 month ago

    Melbourne, Australia Department of Transport and Planning Full time

    Location: Melbourne | Parkville Job type: Ongoing - Full Time Organisation: Department of Transport and Planning **Salary**: $182,813 - $248,629 Occupation: Other Reference: 6054 **About the Role** The Associate Director Contract Management will adopt a risk-based, strategic approach to expand and lead the contract and commercial management function of...

  • Director of Quality Excellence

    2 weeks ago

    Melbourne, Victoria, Australia Michael Page Full time

    Unlock Your Expertise as Director of Quality ExcellenceWe are seeking an accomplished Quality Manager to spearhead our ambitious ERP transformation program.About Our Client:A well-established private holding company with multiple operations in the Middle East, embarking on a strategic journey towards excellence.Job Overview:Key Responsibilities:Develop and...

  • Analyst, Quality Control

    6 months ago

    Melbourne, Australia Moderna Full time

    **The Role**: Reporting to the Quality Control Associate Director, the individual in this role will perform cGMP QC testing for QC Chemistry, release, and stability. He/she will also be responsible for supporting Global GMP stability programs, stability sample set down, pull, and sample shipment/receipt activities. Additionally, the individual in this role...

  • Quality Controller

    6 months ago

    Melbourne, Australia Options Consulting Group Full time

    Market Leader in FMCG Sector with Strong Corporate Culture. - Current HACCP Certification is a must. - Competitive Salary & Work-Life Balance Built on their core competence in developing a range of 100% Australian & Pure Vegetable Purees serving Institutional customers, this organisation has expanded their market offering across multiple channels and...

  • Associate Director

    6 months ago

    Melbourne, Australia RHL Full time

    **Victoria - Melbourne** **up to $160000 per annum, Super + Bonus** **Permanent** Surveying - Job Reference - 270815 Associate Director - Asset Management Melbourne Salary up to $160,000 p.a. (negotiable) + Super + Bonus Hybrid working Are you looking for a strategic role at Associate Director level in Asset Management? Do you have experience of...

  • Analyst, Quality Control

    6 months ago

    Melbourne, Australia Moderna Full time

    **The Role**: Reporting to the Associate Director of Quality Control, the Microbiology & Bioassay Quality Control Analyst, will perform Quality Control testing using Bioassay and Microbiology various testing techniques in a GMP testing environment for mRNA products produced at Moderna’s manufacturing facility and affiliated contract...

  • Project Controls Director

    4 weeks ago

    Melbourne, Victoria, Australia Melbourne Airport Full time

    About the RoleWe are seeking an experienced Project Controls Director to join our team at Melbourne Airport. This is a key leadership role that will play a critical part in driving the success of our capital delivery programs.

  • Associate Director

    1 month ago

    Melbourne, Australia URBIS Full time

    **Who we are**: Urbis is people focussed, and we want the best for our team, our clients, and our communities. We are a community of passionate problem solvers, sought out by clients for our fresh thinking and approach to their city-shaping projects. Our mission is to help create meaningful, sustainable cities & communities. Urbis is an employer of choice...