Manager, Quality Assurance
2 weeks 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.
-
Software Quality Assurance Engineer
5 days ago
Norwood, MA, United States ITW Full timeJob Description: Company Description: Instron is a global organization that designs, manufactures, sells and services mechanical testing systems. Have you ever wondered how a potato chip always has the right crispiness level? Or, how your game controller will survive several drops whether you are excited for your win or upset by a loss? How about eyewear...
-
Billing Quality Assurance Analyst
14 hours ago
Norwood, MA, United States Reliable Respiratory Full timeReliable Respiratory is a Durable Medical Equipment (DME) company that provides the highest quality service for patients needing respiratory, diabetes, urology, and maternity support. Equipment provided includes CPAPs, BiPAPs, AutoPAPs, nebulizers, oxygen equipment, ventilators, CGM devices, insulin pumps, and breast pumps. Each patient is treated with...
-
Senior Design Quality Engineer
4 days ago
Norwood, MA, United States Advanced Instruments Full timeWe Are Now Nova Biomedical! Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and...
-
Data Quality Program Manager
1 week ago
Norwood, MA, United States Rockland Trust Full timeAbout the job: Rockland Trust Bank is driving innovation in how financial services are delivered to our customers and communities. As we expand, we're investing heavily in advanced analytics, data science, and AI to empower smarter decisions, deliver personalized customer experiences, and strengthen our digital transformation. The Data Quality Program...
-
Data Quality Program Manager
2 days ago
Norwood, MA, United States Rockland Trust Full timeAbout the job: Rockland Trust Bank is driving innovation in how financial services are delivered to our customers and communities. As we expand, we're investing heavily in advanced analytics, data science, and AI to empower smarter decisions, deliver personalized customer experiences, and strengthen our digital transformation. The Data Quality Program...
-
Data Quality Program Manager
1 week ago
Norwood, MA, United States Rockland Trust Full timeAbout the job: Rockland Trust Bank is driving innovation in how financial services are delivered to our customers and communities. As we expand, we're investing heavily in advanced analytics, data science, and AI to empower smarter decisions, deliver personalized customer experiences, and strengthen our digital transformation. The Data Quality Program...
-
Data Quality Program Manager
1 week ago
Norwood, MA, United States Rockland Trust Full timeAbout the job: Rockland Trust Bank is driving innovation in how financial services are delivered to our customers and communities. As we expand, we're investing heavily in advanced analytics, data science, and AI to empower smarter decisions, deliver personalized customer experiences, and strengthen our digital transformation. The Data Quality Program...
-
Data Quality Program Manager
4 days ago
Norwood, MA, United States Rockland Trust Full timeAbout the job: Rockland Trust Bank is driving innovation in how financial services are delivered to our customers and communities. As we expand, we're investing heavily in advanced analytics, data science, and AI to empower smarter decisions, deliver personalized customer experiences, and strengthen our digital transformation. The Data Quality Program...
-
RN Required
3 days ago
Norwood, MA, United States Henpen Corporation Full timePatient Care Manager Norwood, Massachusetts, USA Pay Rate - 90000-110000 Job Description We are seeking an experienced and dedicated Patient Care Manager to join our team in Norwood. This role is critical in ensuring the highest standards of patient care within a home health setting. As a leader in this field, you will drive initiatives to improve...
-
RN Required
1 week ago
Norwood, MA, United States Henpen Corporation Full timePatient Care Manager Norwood, Massachusetts, USA Pay Rate - 90000-110000 Job Description We are seeking an experienced and dedicated Patient Care Manager to join our team in Norwood. This role is critical in ensuring the highest standards of patient care within a home health setting. As a leader in this field, you will drive initiatives to improve...
