- Danaher Corporation (Marlborough, MA)
- …the Danaher Business System which makes everything possible. The Quality and Regulatory Support Manager for Cytiva is responsible for supporting the ... Business and Customers in a global environment by providing quality documents and regulatory support in ongoing projects, new product development, change… more
- Olympus Corporation of the Americas (Westborough, MA)
- …Act, Cybersecurity regulations, and relevant consumer protection laws). + Oversee and support regulatory submissions and compliance filings where applicable (eg, ... Manager to plan and direct the OSTA Core Regulatory Affairs Team activities including but not limited to...Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs… more
- Olympus Corporation of the Americas (Westborough, MA)
- …regulatory due diligence in vendor and technology selection. + Oversee and support regulatory submissions and compliance filings where applicable (eg, AI risk ... classification documentation, cybersecurity certifications, and voluntary compliance frameworks). + Support responses to inquiries from regulatory authorities,… more
- ThermoFisher Scientific (Waltham, MA)
- …claims. + Author and/or review regulatory submissions, specifically device master files, regulatory support files, and meeting requests to FDA and other ... cures for cancer. **Discover Impactful Work** As a Sr. Manager , Regulatory Affairs, you will play a...information systems, with our strategic objectives. You will manage regulatory professionals, providing guidance and support to… more
- Dentsply Sirona (Waltham, MA)
- …submissions, FDA 510(k) submissions and EU technical files submissions. + Provides regulatory guidance and support to cross-functional teams throughout the ... portfolio of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and deliver better… more
- Hologic (Marlborough, MA)
- Sr Manager , Quality Assurance Newark, DE, United States Marlborough, MA, United States Are you a strategic leader with a passion for driving compliance, ... regulated environment? At Hologic, we are seeking a **Senior Manager , Quality Assurance** to lead the development,...data to drive decision-making and improvements. + Ability to support audits and regulatory inspections as a… more
- Bristol Myers Squibb (Devens, MA)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Manager , Quality Assurance - Lab Operations is responsible for ... The position plays a key role in maintaining data integrity, supporting regulatory inspections, and driving continuous improvement across quality control… more
- Element Materials Technology (Boxborough, MA)
- …for an experienced quality professional to join its team as a ** Quality Manager ** over-seeing the quality systems of Boxborough, Ma; Pittsfield, ... extended, as agreed with operational management and the Division Quality Manager , to service our customer base...and ensure eQMS usage is monitored and maintained to support quality performance + Develop, analyze and… more
- Bristol Myers Squibb (Devens, MA)
- …at BMS with our Cell Therapy team. This is a key role on the Shop Floor Quality Assurance team. As ** Manager , Shop Floor Quality Assurance, Cell Therapy** , ... compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP. The Manager , Shop Floor Quality Assurance, Cell Therapy is responsible for… more
- Bristol Myers Squibb (Devens, MA)
- …better place than here at BMS with our Cell Therapy team. The **Senior Manager , Quality Assurance Investigations** at the Cell Therapy Facility (CTF) in Devens, ... MA will be responsible for providing quality oversight of the site investigations and CAPA programs...site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and… more
- Skanska (Waltham, MA)
- Skanska is searching for a dynamic Quality Manager . This is a great opportunity to start a career with a company that builds things that matter and values its ... team. We are proud to share our culture of diversity and inclusion. The Quality Manager assists and supports Project Engineer, Project Manager , and… more
- Bristol Myers Squibb (Devens, MA)
- …Global current Good Manufacturing Practices (cGMPs). In the capacity of QA Shop Floor Support , the ** Manager , Shop Floor QA, Cell Therapy** shall be responsible ... here at BMS with our Cell Therapy team. The Quality Assurance Shop Floor (QASF) organization has responsibility for...relevant governance forums. Additionally, the incumbent shall flex to support ad-hoc deviation approval or batch record review as… more
- Bristol Myers Squibb (Devens, MA)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager , Quality Systems - Change Control and Quality ... a risk-aware culture at BMS and ensure alignment of these efforts with broader Quality initiatives. + Support front room External Inspection activities as site… more
- Olympus Corporation of the Americas (Westborough, MA)
- …+ Participate in teams for sustaining products to provide input on global regulatory requirements. + Support regulatory submissions, filings, and responses ... of a high-growth, innovative team, the RA Specialist II will provide regulatory guidance, prepare and maintain documentation, and support submissions related… more
- Curia (Hopkinton, MA)
- Manager , Quality Control Strategy in Hopkinton, MA Build your future at Curia, where our work has the power to save lives. The Manager , Quality Control ... is responsible for the planning and organization of the Quality Control function at the site. The Manager...to ensure adherence to schedule and compliance with applicable regulatory requirements. Curia is a global contract development and… more
- Bristol Myers Squibb (Devens, MA)
- …here at BMS with our Cell Therapy team. Bristol Myers Squibb is seeking a ** Manager , QC Sample Management** at the Cell Therapy Facility (CTF) in Devens, MA. This ... for the management of QC samples and materials in support of the QC laboratories. This includes, but is...a daily work plan for QC associates. Report out quality and operational metrics. + Responsible for management of… more
- Astellas Pharma (Westborough, MA)
- **Validation Manager ** Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and ... AIRM is headquartered in Massachusetts. Astellas is announcing a **Validation Manager ** opportunity at their **Astellas Institute for Regenerative Medicine (AIRM)**… more
- Fallon Health (Worcester, MA)
- …Manages NaviCare members in conjunction with the Navigator, Behavioral Health Case Manager , Aging Service Access Point Geriatric Support Service Coordinator, ... Founded in 1977 in Worcester, Massachusetts, Fallon Health delivers equitable, high- quality , coordinated care and is continually rated among the nation's top… more
- Sartorius (Marlborough, MA)
- …according to the quality , costs, schedule, and compliance goals. As the Manager of Process Engineering, you will be responsible for defining and implementing the ... As the Manager of Process Engineering, you will be responsible...quality standards + Deep understanding of GMP requirements, regulatory compliance, and validation procedures in biotech/pharma settings +… more
- Gentiva (Worcester, MA)
- …strategic oversight? If so, you could be the next Hospice Patient Care Manager Senior on our team. At Gentiva Hospice, we're dedicated to providing compassionate ... patients live with dignity and comfort. As a Senior Patient Care Manager , you'll help guide branch-level clinical operations, oversee direct patient care activities,… more