Associate Director* QA (Operations & Compliance)
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Who we are:
We are a global immunotherapy company. Our 4,000+ colleagues globally are committed to improving the health of people worldwide with our fundamental research utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We leveraged our mRNA technology to develop a COVID-19 vaccine which became the first mRNA drug approved for human use.
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”. The aim is to build a regional manufacturing network in Africa, with Africa, for Africa.
Why we need you:
The BioNTainers will be equipped to produce a range of mRNA-based vaccines targeted towards the needs of African Union member states. You will become part of the regional staffing team, driving the establishment of the regional African end-to-end mRNA manufacturing network.
Associate Director* QA (Operations & Compliance)
Responsible for establishing, maintaining, and developing Quality Assurance (QA) Operations teams and processes for the Rwanda (RWA) BioNTainer site. Responsible for ensuring GMP compliance and performing QA Operations activities 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 high BioNTech standards of Quality under GMP.
Your main responsibilities are:
- Close collaboration and partnership with the Global QA BioNTainer Set-up & Support Team, the Rwanda Quality organization, and the Quality organizations across BioNTech to ensure all regulations and procedures are followed in Rwanda.
- Build, maintain, and develop a team of QA operations 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 Rwanda BioNTainer site by ensuring local GMP Quality operations activities and procedures are implemented in compliance to regulations and global policies.
- Support the Rwanda head of QA in representing BioNTech Rwanda QA to internal (local and global) and external stakeholders; including support in shaping of local processes and regulations.
- Help to establish and develop a fit-for-purpose Operations QA organization in Rwanda including continuous improvement.
- Lead and continue to develop the Operations QA team and efficiently manage the site QA Operations team(s) resource allocation.
- Oversight and support for quality system implementation and management
- Establish and implement documentation control (including change control, deviations, investigation, and CAPAs), provide end-to-end document management oversight (e.g., document creation and archiving).
- 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), author internal audit reports, Develop and implement an inspection readiness process.
- Establish and maintain GMP compliance, author procedures and documents (e.g., SOPs), and contribute to regulatory submissions and Annual Product/PQ reviews.
- Develop, manage, and maintain Quality metrics for the site.
- Expectation for hands-on, interactive, and practical leadership.
- Train and mentor staff.
What you have to offer:
Education:
- Bachelor’s degree in relevant scientific discipline, and additional qualifications (MSc, MBA) are advantageous.
Professional experience:
- 8+ years significative experience within the pharmaceutical industry.
Languages:
- Fluency in English (written and spoken) is essential.
Competencies:
- Working knowledge of 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.
- Operations experience across pharmaceutical GMP functions.
- 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.
Benefits for you:
We offer a competitive compensation package which will be determined by the contract type and selected candidate’s qualifications and experience.
How to apply:
Apply now and simply send 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 by using our online form.
Please note:
- Only applications sent via our online form shall be considered.
- Only Candidates with the right qualifications and relevant experience shall be shortlisted and
- Incomplete applications shall be rejected.
- Please note that BioNTech will run a background check during the hiring process
We are looking forward receiving your application.
*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!
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