Associate Director, QA Operations – Systems QA

Role Overview

• Close collaboration and partnership with the Global QA BioNTainer Set-up & Support Team, the Australia Quality organization, and the Quality organizations across BioNTech 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 BioNTainer 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 BioNTech 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, CoA, 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.

Requirements

• 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.

Benefits

• 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.
• 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.