Sr. Manager, Combination Product Quality

Moderna Therapeutics - Norwood, MA

Full-time - Mid Level

Norwood, MA

Professional, Scientific, and Technical Services

About the position

The Senior Manager, Combination Product Quality is responsible for overseeing quality assurance for combination products and medical devices at Moderna. This role involves ensuring compliance with regulatory standards, guiding design control and risk management activities, and collaborating with various teams to support product development and continuous improvement. The position requires a strong background in biotech or pharmaceutical environments, particularly in cGMP quality systems.

Responsibilities

• 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, 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.
• Provide technical quality support in development and on-market products through supporting root cause investigations and incident management.
• Support the development of policies and procedures in the evolution and continuous improvement initiatives of the Global Quality Management System.
• 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.

Requirements

• Bachelor's degree 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.
• Experience in Combo product/s development and medical device as QA engineer is a plus.
• Experience in working with CMO/CLO for process validation and product testing.
• Strong scientifically with technical expertise to ensure robust analysis of complex device product data.
• Excellent interpersonal skills using a team-oriented approach to project management and problem solving.
• Outstanding communication skills (verbal and written).
• Ability to navigate through ambiguity and rapid growth and adapt to change.

Nice-to-haves

• Experience in a biotech or pharmaceutical development environment.
• Ability to interact effectively with all levels of personnel within the organization.
• A 'digital first' and curious mindset that allows you to constantly learn and challenge the status quo.

Benefits

• Highly competitive and inclusive medical, dental and vision coverage options.
• Flexible Spending Accounts for medical expenses and dependent care expenses.
• Lifestyle Spending Account funds for personal enrichment and self-care activities.
• Family care benefits, including subsidized back-up care options and on-demand tutoring.
• Free premium access to fitness, nutrition, and mindfulness classes.
• Exclusive preferred pricing on Peloton fitness equipment.
• Adoption and family-planning benefits.
• Dedicated care coordination support for our LGBTQ+ community.
• Generous paid time off, including vacation, sick time, and holidays.
• Volunteer time to participate within your community.
• Discretionary year-end shutdown.
• Paid sabbatical after 5 years; every 3 years thereafter.
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents.
• 401k match and Financial Planning tools.
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options.
• Complimentary concierge service including home services research, travel booking, and entertainment requests.
• Free parking or subsidized commuter passes.