Carrier · 18 hours ago
Quality Assurance Manager
CAM60: Sensitech, Inc., 800 Cummings Center, Beverly, MA, 01915 USA
Full-time
Onsite
Mid, Senior Level
$120K/yr - $168K/yr
5+ years expCarrier Global Corporation is a global leader in intelligent climate and energy solutions. The Quality Assurance Manager oversees the quality management program for Sensitech’s pharma and life sciences operations, ensuring compliance with regulatory standards and promoting a culture of continuous improvement.
EnergyHeating Ventilation and Air Conditioning (HVAC)
No H1B
Responsibilities
Develop, implement, and maintain Quality Management System (QMS) procedures related to Quality Assurance (QA) aligned with GMP, GDP, ISO 9001, ISO 13485, and applicable regulatory requirements
Ensure compliance with FDA, EMA, ICH, and other relevant regulatory bodies for pharmaceutical and life sciences operations
Review and approve SOPs, work instructions, quality records, and validation documentation
Support external customer audits
Oversee QA activities for product development, manufacturing, packaging, and distribution
Monitor product release processes to ensure compliance with quality and regulatory requirements
Manage investigations of deviations, non-conformances, Out-of-Specification (OOS) results, and customer complaints
Approve Corrective and Preventive Actions (CAPA) and verify their effectiveness
Conduct risk assessments for products, processes, and suppliers
Implement quality metrics and reporting systems to track compliance and performance
Lead continuous improvement initiatives to enhance process efficiency, product reliability, and regulatory compliance
Support change control processes and assess the impact of changes on product quality and compliance
Mentor and guide QA employees; promote a culture of quality awareness across the organization
Collaborate with cross-functional teams including Engineering, Operations, Supply Chain, and Regulatory Affairs
Act as the primary QA contact for suppliers, contract manufacturers, and logistics partners
Provide quality guidance and training to employees at all levels
Qualification
Required
Bachelor's degree
5+ years of experience in quality assurance in pharma, biotech, or life sciences
2+ years of experience in leading global teams
Must have unrestricted authorization to work in the USA. No visa sponsoring available
Preferred
Bachelors in Life Sciences, Pharmacy, Biotechnology, or Engineering
Master's degree in Life Sciences, Pharmacy, Biotechnology, Engineering
Experience with cold-chain monitoring, logistics, or medical device quality systems
Familiarity with electronic quality systems (EQMS) and digital tools for QA/QC management
Certification in quality (e.g., CQE, CQA, Six Sigma)
In-depth knowledge of GMP, GDP, ISO 9001, ISO 13485, and FDA/EMA regulations
Experience with validation, qualification, and quality control processes in a regulated environment
Leadership and interpersonal skills
Analytical and problem-solving abilities
Detail-oriented, organized, and able to handle multiple projects simultaneously
Effective English written and verbal communication skills, including report writing and documentation review
Benefits
Health Care benefits: Medical, Dental, Vision; wellness incentives
Retirement benefits
Time Off and Leave: Paid vacation days, up to 15 days; paid sick days, up to 5 days; paid personal leave, up to 5 days; paid holidays, up to 13 days; birth and adoption leave; parental leave; family and medical leave; bereavement leave; jury duty; military leave; purchased vacation
Disability: Short-term and long-term disability
Life Insurance and Accidental Death and Dismemberment
Tax-Advantaged Accounts: Health Savings Account; Healthcare Spending Account; Dependent Care Spending Account
Tuition Assistance
Company
Carrier
Carrier is the provider of intelligent climate and energy solutions.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
David Gitlin
Chairman & Chief Executive Officer
Gary Boucher
Chief of Staff to the Chairman & CEO
Recent News
Morningstar.com
2025-12-16
2025-11-20
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