Sr. Manager, Quality Assurance
hace 4 semanas
The Role : The Senior Manager of Quality Assurance Disposition, Deputy Qualified Person for Moderna's International Organization will act as Deputy Qualified Person in accordance with EU GMP to provide final certification/release along with ensuring overall maintenance of site quality management system (QMS) to support release of product for EU/EEA markets as well as wholesale distribution to EU countries.
The Deputy QP will perform audits of third-party providers, suppliers, and contract manufacturing and testing organizations in order to ensure EU GMP standards have been achieved and will support the internal audit program to enable permanent inspection readiness.
This Deputy QP Role will also provide QP GMP declarations in support of importation activities and will be expected to maintain up to date awareness of regulatory issues and international regulatory requirements.
This role will work cross-functionally to create and maintain standards for GXP compliance and will have a high degree of impact across the organization.
The incumbent will provide QP support during weekends.
Here's What You'll Do Execute, according to a written delegation, QP responsibilities, duties, batch certification and disposition for products in the EU as defined in EU Council Directives and Eudralex Volume 4, Annex 16.
Ensure products are manufactured in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.
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 conducting any 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.
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.
Act as contact person for product defects and recalls for EMA and support recall of product if needed.
Provide QP GMP declarations in support of regulatory filings and assist in maintaining GMP/GDP regulatory licenses.
Perform QP Audits internally and externally of suppliers and contract testing and contract manufacturing organizations and support health authority inspections.
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.
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 acting and executing Qualified Person responsibilities and duties as defined in EU directive 2001/83/EC (as amended) is a plus.
Experience in release of commercial product including biotech/sterile products.
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, while meeting all deliverables and timelines.
Experience conducting contract assessments across the GXP space.
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 complex regulatory environments and maintain compliance.
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