Manager Operations & Systems QA AUS

Melbourne, Australia   |   full time   |   Job ID: 10726 

Responsible for ensuring GMP compliance and performing Quality Assurance (QA) operations and systems activities for the Australia (AUS) BioNTainer site. Responsible for establishing, maintaining, and developing Quality Assurance (QA) Operations and Systems processes for the site. This role will also be responsible for helping to develop and ensure the Quality mindset of the organization and preserve compliance with national and international regulations. This is achieved within the framework of regulatory compliance and operating within established BioNTech’s high standards of Quality under GMP.

Your main responsibilities are:

• Close collaboration and partnership with the Global QA BioNTainer Set-up & Support Team, the AUS Quality organization, and the Quality organizations across BioNTech to ensure all regulations and procedures are followed in Australia.
• Implement and set-up local GMP standards and procedures, a quality system, documentation control (e.g., change control, deviations, CAPA), training, metrics, audits and inspections, as examples.
• Help to set up and establish the AUS BioNTainer site by ensuring local GMP Quality operations and systems activities and procedures are implemented in compliance to regulations and global policies.
• Support the AUS QA Operations and Systems organization in shaping local processes in representing BioNTech Australia QA to internal (local and global) and external stakeholders.
• Help to establish and develop fit-for-purpose QA Operations and Systems processes, ensuring GMP compliance, and performing QA operations and systems activities for the site.
• Oversight and support for quality system implementation and management.
• Establish and implement quality processes for change control, deviations, investigations, CAPAs, and documentation control including end-to-end document management oversight (e.g., issuance, archiving), as examples.
• Provide general manufacturing and disposition support (batch records, CoA, EM, TEs, line clearance, CC, deviations and investigations, documentation support, etc.) in partnership with the Technical QA and Product Release functions.
• Contribute to and support audits and inspections (internal and external), and the development and implementation of an inspection readiness process.
• Help to establish and maintain GMP compliance, author QA procedures and documents (e.g., SOPs), and contribute to regulatory submissions and periodical quality reviews.
• Support and help manage and maintain Quality metrics and continuous improvement initiatives for the site.
• Expectation for hands-on, interactive, and practical leadership; continuous learning and development; training and mentoring staff.

What you have to offer:

• University degree (e.g., Bachelor’s degree) in relevant scientific discipline, and additional qualifications (MSc, MBA) are advantageous.
• 6-8+ years of relevant experience in a pharmaceutical industry GMP/GDP experience
• Working knowledge of relevant regulations and guidelines (e.g., TGA, PIC/S, ICH), and additional experience with WHO, EMA, US FDA etc. are advantageous.
• Experience with national or international regulatory agency and participation in hosting/supporting inspections is advantageous.
• Quality Operations experience across pharmaceutical GMP functions (additional experience within a technical quality function is desirable)
• Experience within a quality organization in supporting development of IMPs (vaccines, biologics and ATMPs) through clinical phase is advantageous.
• Sterile manufacturing and filling operations experience is highly advantageous
• Strong solution driven mindset and desire to learn.
• Ability to conceptualize, analyze, plan and manage in a fast-paced environment.
• Ability to be agile, effectively collaborate, and build consensus in a dynamic, cross-functional environment.
• Excellent interpersonal skills; outstanding communication skills (verbal and written).
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• Fluency in English (written and spoken) is essential.

What we do with the BioNTainers:

We want to improve healthcare by making our innovations accessible worldwide. Therefore, we developed the first modular mRNA-manufacturing facilities based on a container solution called “BioNTainers”. Help us build a regional manufacturing network in Africa & Australia: With the region and for the region. As a part of the local team, driving the establishment of the regional end-to-end mRNA manufacturing solutions.

Benefits for you:

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.

Click here to find out more about what we do, the careers we offer ans also the benefits we provide. Note: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.

How to apply:

Apply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.

Please note:

Only applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.

We are looking forward receiving your application.