- ThermoFisher Scientific (Bedford, MA)
- …Impact** Leading quality efforts for PPA, the Director reports to the VP of Quality & Regulatory at BPG. They drive a customer-focused quality culture ... (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Description: Director, Quality - Purification & Pharma Analytics (PPA)** **How You'll Make… more
- Hologic (Marlborough, MA)
- …+ Strong understanding of Quality Management Systems (QMS), CAPA processes, and regulatory requirements, including ISO 13485 and FDA QMSR. + Familiarity with ... Quality Engineer 2 Marlborough, MA, United States Are...and sustaining engineering. + Proven track record of supporting regulatory audits and maintaining audit-ready documentation. + Preferred: Experience… more
- Teleflex (Mansfield, MA)
- …to troubleshoot and resolve them. * Ensure Compliance: Adhere to all safety, regulatory , and quality standards in all tasks. * Additional responsibilities may ... experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired * Experience in… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the compliance of deviation ... This role focuses on defining activities, processes, and standards to meet quality requirements relevant to deviation management and serious breach. This position… more
- Bristol Myers Squibb (Devens, MA)
- …and EU cGMP regulations and guidance. + Knowledge and proven experience in FDA , EMA, or other regulatory authority. + Demonstrated leadership, interpersonal, ... BMS with our Cell Therapy team. The **Senior Manager, Quality Assurance Investigations** at the Cell Therapy Facility (CTF)...site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and… more
- Kelly Services (Boston, MA)
- …protocols and procedures. + Collaborate with cross-functional teams to ensure compliance with regulatory standards. + Analyze quality data and trends to identify ... Kelly Science is seeking a Quality Assurance Specialist to join a client located...the biotechnology or pharmaceutical industry. + Strong knowledge of regulatory requirements and industry standards (eg, FDA ,… more
- Hologic (Marlborough, MA)
- …architecture diagrams. + Collaborate with cross-functional teams (Product Engineering, DevSecOps, Regulatory , Quality ) to integrate security into the product ... Hologic products, and manage these risks according to established quality procedures. + Participate in continuous improvement of our... FDA submissions. + Maintain current knowledge of FDA and other regulatory body's cybersecurity guidance… more
- Bristol Myers Squibb (Devens, MA)
- …no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and ... Shop Floor QA, Cell Therapy** shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks, routine communication… more
- Bristol Myers Squibb (Devens, MA)
- …there's no better place than here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor team is responsible for 24x7 Quality collaboration and ... oversight of site operations, including but not limited to Manufacturing, Quality Control laboratories, and Warehouse Operations. The **Senior Specialist, Quality… more
- Bristol Myers Squibb (Devens, MA)
- …lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager, Quality Systems - Change Control and Quality Risk Management ... (QRM) Process Owner is responsible for ownership and oversight of assigned quality systems per established local and global standards. This local process owner is… more