Manager, Internal Quality Operations
ModernaThe Role:
ModernaTX, Inc. seeks a Manager, Internal Quality Operations for its Norwood, Massachusetts location.
Here’s What You’ll Do:
On behalf of a global biotechnology company, oversee Quality Assurance (QA) operations for clinical-stage drug product manufacturing, including isolator-based aseptic fill-finish and packaging and labeling processes, ensuring compliance with good manufacturing practices (GMP).
Serve as the QA contact for the development and startup of a new aseptic fill-finish manufacturing facility, supporting equipment qualification, process validation readiness, and implementation of quality systems.
Provide QA operations support for drug product manufacturing, including aseptic behavior monitoring and oversight, batch record review, line clearance, visual inspection quality oversight, in-process checks, packaging and labeling review, and management of room changeovers.
Lead and coordinate deviation investigations and change controls for drug product manufacturing, including coordination of root cause analysis, cross-functional impact assessments, and timely closure of major and recurring quality issues.
Drive documentation improvements by managing updates to batch records and standard operating procedures to support manufacturing accuracy and regulatory compliance.
Facilitate technology transfer scheduling and execution by coordinating with supply chain, engineering, manufacturing science and technology (MST) and manufacturing operations teams to align quality oversight with production planning, material traceability, and process control strategies.
Support team development through mentoring, coaching, and performance feedback, while contributing to hiring activities and promoting continuous improvement within the QA group.
Lead quality-driven projects to improve operational efficiency and compliance.
Contribute to quality oversight through review and presentation of performance metrics, risk summaries, and investigation status to support proactive compliance and continuous improvement.
Support audit readiness for internal inspections and third-party audits by ensuring documentation completeness, floor compliance, and cross-functional coordination.
Provide on-site support during audits and serve as the drug product Quality point of contact.
Oversee day-to-day quality assurance support services coordination including task delegation.
Here’s What You’ll Bring to the Table:
Minimum Requirements:
Requires a minimum of a Master’s degree in Biotechnology, Pharmaceutical Sciences, or related field and two (2) years of experience as a QA Specialist, Quality Control Specialist, Senior Technician – Quality Control, Sterility Assurance Specialist, or related position supporting Quality activities in healthcare manufacturing.
Alternatively, employer will accept a Bachelor’s degree in fields specified and five (5) years of the specified progressive, post-baccalaureate experience.
Two (2) years of experience must include:
GMP compliance and audit readiness and participation;
Quality event management, including deviation investigations, and CAPA (Corrective and Preventive Actions);
Quality data analysis to drive continuous improvement; and
Quality system and documentation management utilizing eQMS (Electronic Quality Management System), EAM (Enterprise Asset Management), ERP (Enterprise Resource Planning) and MES (Manufacturing Execution System) platforms.
Must also have experience with: Providing QA support and quality support for facility-startup validation activities.
Position requires a 4-day, 10-hour schedule; afternoon/night shift; includes weekend work
The salary range for this role is $109,200 to $174,600. This range reflects the lowest to highest salary we, in good faith, believe we would pay for this role at the time of this posting. The minimum target pay for this particular position, based on its primary location, is $138,000 to $174,600. An individual’s placement within the range will depend on several factors, including but not limited to specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
Apply at https://modernatx.wd1.myworkdayjobs.com/en-US/M_tx (Job ID: R19154) or email resume and cover letter to careers@modernatx.com with subject line: R19154
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
#DNI
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.
Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.