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Manager, Operations and Systems QA
BioNTech SEManager Operations & Systems QA ensuring GMP compliance and managing Quality Assurance processes at BioNTech's BioNTainer site in Australia.
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.
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Quality System ImplementationDocumentation ControlChange ControlCAPA ManagementBatch Record ReviewRegulatory SubmissionsQuality AuditsContinuous Improvement InitiativesIMP Development SupportTechnical Quality Functions
Soft Skills
Interpersonal SkillsCommunication SkillsAgilityProblem-SolvingCollaboration
Certifications
Bachelor’s Degree in Relevant Scientific DisciplineMSc or MBA (Advantageous)