Manager, Quality Assurance
6 days ago
ModernaTX, Inc. seeks a Manager, Quality Assurance for its Norwood, Massachusetts location.
Here's What You'll 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.
Minimum requirements:
- Requires a Master's 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.
- Applying knowledge of validation protocols, including equipment qualification;
- May telecommute up to 1 day per week.
- 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 $149,400 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.
#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.
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