Release QA Manager, Quality Assurance Disposition - Basel

Job content

**Please kindly submit your resume in English. Moderna uses English as our standard business language. Danke**

The Role

TheRelease QA Managerfor Moderna’s International Organization will support the product release (including market release) for International markets (EU and ROW) as well as wholesale distribution to these countries. He/shewill work closely with the EU QPs to support EU batch certification of products and cross-functionally to create and maintain standards for GXP compliance and will have a high degree of impact across the organization.

Here’s What You’ll Do

• Ensure products (DS and DP) are manufacturing in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.
• Oversee GDP related activities throughout the product supply chain, including transportation activities and customer qualification activities.
• Maintain thorough and up to date understanding of international regulatory requirements and guidance.
• Take actions necessary to maintain and extend technical and professional competence in support of QP responsibilities and ensure thorough understanding of any products and processes prior to the QP batch certification and disposition.
• Understand and support review of investigations, root cause analysis and review and approval of major/critical deviations, complaints and change controls with process and product impact.
• Perform product impact assessments, including for temperature excursions.
• Support Quality Systems and Compliance on continuous improvement of the Quality Management System (QMS), support quality management review processes, annual product quality reviews, overall inspection readiness and state of control.
• Establish and maintain effective communication with clients to match internal and external expectations.
• Interact with Health authorities as it pertains to Moderna’s licenses and regulatory activities.
• Supportproduct defects and recallsassessments if needed.
• Ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing and timely release, and distribution of quality product, and consistent with the global quality strategy and meet all relevant regulatory requirements including local and international regulations and applicable standards and guidance’s.
• Support review of international regulatory filing information to ensure data integrity and regulatory compliance
  

Here’s What You’ll Bring To The Table

• Bachelor’s degree with a minimum of 5-10 years of international quality experience in the biotechnology or pharmaceutical industries; Advanced degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering) preferred.
• Experience in release of commercial product including biotech/sterile products, or in GDP QA activities, or in manufacturing QA Operations. Experience in Vaccines release to the Market is a plus.
• Thorough knowledge in cGMP global regulatory requirements, quality systems and importation requirements.
• Proven track record in interacting with QA and regulatory teams and successful health authority inspection experience.
• Ability to serve on multiple interdepartmental teams and to act as team leader when appropriate.
• Proven ability to lead and manage projects/teams of significant scope and complexity, directly or indirectly, while meeting all deliverables and timelines.
• Excellent working knowledge, understanding and experience with practical implementation of local laws, FDA and EMA regulations and industry guidelines including data integrity, computer system validation and electronic records and signature requirements.
• Exceptional oral and written communication skills to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations.
• A leader who is self-reflective and leads by example and drives the organization’s performance with an attitude of continuous improvement by being open to feedback and self-improvement.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
  

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit

Moderna is a smoke-free, alcohol-free and drug-free work environment.