Release QA Manager, Quality Assurance Disposition
vor 3 Wochen
**The Role**:
The Release QA Manager for 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/she will 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.
Support product defects and recalls assessments 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.
Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.
We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras
The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.
About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RN
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