Associate Director QA Operations & Systems Join to apply for the Associate Director QA Operations & Systems role at Bio NTech SE Associate Director QA Operations & Systems 19 hours ago Be among the first 25 applicants Join to apply for the Associate Director QA Operations & Systems role at Bio NTech SE Get AI-powered advice on this job and more exclusive features.
Melbourne, Australia | full time | Job ID: 9364As Associate Director QA Operations and Systems, you will be responsible for establishing, maintaining, and developing Quality Assurance (QA) Operations and Systems teams and processes for the Australia (AUS) Bio NTainer site.
Responsible for ensuring implementation of GMP compliant operations and quality system at 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 Bio NTech's high standards of Quality under GMP.Your main responsibilities are:Close collaboration and partnership with the Global QA Bio NTainer Set-up & Support Team, the Australia Quality organization, and the Quality organizations across Bio NTech to ensure all regulations and procedures are followed in Australia.
Build, maintain, and develop a team of QA operations & systems experts.
Create and implement 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 Australia Bio NTainer site by ensuring local GMP Quality operations activities and procedures are implemented in compliance to regulations and global policies.
Support the Australia Head of QA in representing Bio NTech Australia QA to internal (local and global) and external stakeholders.
Help to establish and develop a fit-for-purpose QA Operations and Systems organization including continuous improvement.
Lead and continue to develop the QA Operations and Systems team and efficiently manage the site QA Operations and Systems organization resource allocation.
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, Co A, EM, TEs, line clearance, CC, deviations and investigations, documentation support, etc.) in partnership with the Technical QA and Product Release functions.
Lead and manage audits and inspections (internal and external); develop and implement an inspection readiness process.
Establish and maintain GMP compliance, author QA procedures and documents (e.g., SOPs), and contribute to regulatory submission and periodical quality reviews.
Develop, manage, and maintain Quality metrics for the site.
Support the Head of QA in the implementation and running of the site Quality Council.
Expectation for hands-on, interactive, and practical leadership; train and mentor staff.
What you have to offer:University degree (e.g., Bachelor's degree) in relevant scientific discipline, and additional qualifications (MSc, MBA) are advantageous.
8+ years of relevant experience in a pharmaceutical industry, GMP/GDP experience.
Working knowledge of TGA and PIC/S relevant regulations and guidelines (experience with ICH, US FDA, EMA, etc.
are advantageous).
Experience in hosting inspections and collaborating with national or international regulatory agencies.
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) from early through late-phase clinical trials 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.
Experience leading team/budget.
Fluency in English (written and spoken) is essential.
Your Benefits:Bio NTech 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.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, Bio NTech will conduct the background check through our service provider 'Hire Right'.
You will be informed accordingly by your Bio NTech-Recruiter.We are looking forward receiving your application.
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