Manager, Quality Assurance

Norwood, OH - USA

Monthly Salary: $ 149400 - 174600

Posted on: 6 days ago

Vacancies: 1 Vacancy

Job Summary

The Role:

ModernaTX Inc. seeks a Manager Quality Assurance for its Norwood Massachusetts location.

Heres What Youll Do:

Support biotechnology therapeutic programs by focusing on quality oversight for validation processes in compliance with Good Manufacturing Practices (GMP) and regulatory standards.
Manage the review and approval of validation records and associated documentation related to equipment including qualification induction decommissioning and maintenance process
including cleaning validation smoke studies and medial fills and facilities including build-outs shutdowns and critical utility qualification.
Manage Commissioning Qualification and Validation (CQV) activities investigate discrepancies and address compliance issues for facilities utilities systems and equipment.
Assess change control implementations and ensuring timely resolution of compliance and quality systems issues.
Ensure adherence to data integrity and Good Documentation Practices (GDP) practices to support audit and inspections.
Drive continuous improvement initiatives and participate in cross-functional projects to support equipment utilities and facilities validation.
Ensure seamless alignment of validation activities with operational and regulatory goals.

Heres What Youll Bring to the Table:

Minimum requirements:

Requires a Masters degree in Mechanical Engineering Chemical Engineering or related field and 3 years of experience as a QAV Engineer QAV Engineer Consultant Validation Engineer Quality/Validation Engineer or related position.
3 years of experience must include:
- Applying knowledge of validation protocols including equipment qualification;
- Ensuring compliance with GxP GMP & GDP regulatory requirements;
- Change control assessments and implementation for validation processes;
- Investigating and resolving issues in manufacturing processes; and
- Identifying and implementing process improvements to enhance manufacturing efficiency.
May telecommute up to 1 day per week.
The salary range for this role is $109200 to $174600. 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 $149400 to $174600. An individuals 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 (Job ID: R18558) or email resume and cover letter to with subject line: R18558.

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Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat 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.

Required Experience:

Manager

The Role: ModernaTX Inc. seeks a Manager Quality Assurance for its Norwood Massachusetts location.Heres What Youll Do: Support biotechnology therapeutic programs by focusing on quality oversight for validation processes in compliance with Good Manufacturing Practices (GMP) and regulatory standards.M...