Sr. Manager, Combination Product Quality

The Role

Located in Norwood, MA and reporting to the Director, Technical Development Quality Assurance, the Senior Manager, Combination Product Quality will be responsible for quality oversight of design control and risk management activities for combination products and medical devices in development and on-market products to ensure alignment with current regulatory expectations for combination products and medical devices.  

In collaboration with the device development teams and medical device suppliers and testing partners, this individual will support development, implementation, and continuous improvement of Moderna’s products. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

Here’s What You’ll Do

• Provide guidance and make Quality decisions on Combination product development and regulatory strategies. Proactively support design control activities as governed by project plan

• Lead Quality review and approval of all technical documentation for device development technical and risk management documentation including planning, traceability matrix, protocols and reports, and risk assessments

• Support design-related continuous improvement efforts, design changes, and market expansions.

• Support post market surveillance activities including complaint management and medical device and vigilance reporting.

• Act as global Quality representative in cross-functional forums to provide support and oversight to internal and external manufacturing and testing facilities for application of the device and combination products, Global policies, SOPs, and Standards throughout the lifecycle of products.

• Provide technical quality support in development and on-market products through supporting root cause investigations, and incident management (Deviations/CAPAs) across Moderna’s internal and external manufacturing and testing sites

• In collaboration with Quality System business process owners and site quality operations teams, support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System

• In partnership with the Digital team, identify and implement tools and electronic Quality systems to improve efficiencies of processes

• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.

• Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.

• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.

• Complete training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Bachelor’s degree, preferably in Sciences or Engineering with applied Quality industry experience of 5 years; 3 with MS.

• Mastery of relevant FDA, EU regulations, ICH standards/guidelines, and ISO requirements, and experience in supporting successful regulatory inspections.

• Experience in Combo product/s development, experience in medical device as QA engineer is a plus.

• Experience in working with CMO/CLO for process validation and product testing.

• Ability to interact effectively with all levels of personnel within the organization.

• Strong scientifically with technical expertise to ensure robust analysis of complex device product data and the ability to use that information to make scientifically sound Quality risk-based recommendations.

• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issue resolution in a scientifically sound and understandable way. 

• Outstanding communication skills (verbal and written). 

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment.

• A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo.

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

Moderna is pleased to provide you a