Manager, Operations and Systems QA

BioNTech SE

Manager Operations & Systems QA ensuring GMP compliance and managing Quality Assurance processes at BioNTech's BioNTainer site in Australia.

Posted 7/7/2026full-timeMelbourne • 🇦🇺 AustraliaMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in GMP compliance and Quality Assurance operations, with a strong focus on establishing and maintaining quality systems, documentation control, and regulatory compliance. Proven ability to lead and mentor teams while effectively collaborating with internal and external stakeholders.

Highest-signal resume keywords

GMP ComplianceQuality Assurance OperationsRegulatory Knowledge (TGA, PIC/S, ICH)Quality Metrics ManagementSterile Manufacturing Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System ImplementationDocumentation ControlChange ControlCAPA ManagementBatch Record ReviewRegulatory SubmissionsQuality AuditsContinuous Improvement InitiativesIMP Development SupportTechnical Quality Functions

Soft Skills

Interpersonal SkillsCommunication SkillsAgilityProblem-SolvingCollaboration

Certifications & Qualifications

Bachelor’s Degree in Relevant Scientific DisciplineMSc or MBA (Advantageous)

Industry Keywords

Pharmaceutical IndustryGMPGDPBiologicsVaccinesATMPsWHOEMAUS FDAInspection Readiness

About the role

Key responsibilities & impact

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.
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.
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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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.