Global Quality Director
3 weeks ago
As the Global Quality Director, you will play a pivotal role in leading and shaping the quality management strategy and set up of our global organization that is part of a larger company group. You will be responsible for ensuring that our products and services consistently meet or exceed customer expectations and comply with regulatory standards. The successful candidate will drive a culture of continuous improvement, understands that quality starts with the design of our product and collaborates cross-functionally to implement effective quality management systems & successful quality assurance programs.
- Develop quality department structure and vision.
- Oversee the implementation and maintenance of robust quality management systems and ensures compliance with industry regulations, standards, and certifications.
- Create, implement and maintain a compliance auditing program.
- Identify critical operation issues including quality, regulatory and resource issues that impact production projects.
- Provide guidance to effectively resolve deviations and out-of-specification results and work closely with QC/Manufacturing to develop plans for investigations and corrective actions.
- Drive a culture of continuous improvement throughout the organization.
- Establish an understanding across departments how strong processes lead to a greater customer experience.
- Lead the quality organization with openness, predictability and a clear focus on team and employee development. Hire, train, coach, council and manage all quality staff to achieve department/organization goals and support personal growth. Develop and maintain Budgets and hiring plans.
- Coordinate reporting as it relates to quality activities, benchmarks and completion of projects.
- Maintains product quality by enforcing quality assurance policies and procedures and government requirements; collaborating with other members of management to develop new product and engineering designs and manufacturing and training methods.
- Represent QA in management teams. Ensures the evaluation, trending, and communication of quality data and information for management review.
- Develops plans and implements actions to ensure that each site operates in conformity with handbook and regulations. Ensures site readiness for regulatory and audit inspections.
- Oversees the performance of all deviation investigations; ensures robust corrective actions are identified and implemented.
- Establishes and maintains systems for the quality oversight of outsourced operations (e.g. contract manufacturers, contract laboratories), including but not limited to review and approval of deviations, and maintenance of Quality Agreements.
- Collaborate with the supply chain team to establish and maintain strong supplier quality management processes
- Collaborate with R&D, manufacturing, supply chain, and other departments to integrate quality into all aspects of the product life cycle.
- Establishes design quality.
We offer a full benefit package that includes Basic Life, Vision, and Short and Long Term Disability provided by the Company at no cost to you. Medical, Dental, Additional Life Insurance and Vision insurance for employee and family, Identity Theft Protection, and Legal Services Benefit are available at group rates through payroll deduction. A 401(k) Retirement Plan, Flexible Spending and Dependent Day Care Accounts are available. Benefits are available the first of the month following the hire date except for Short and Long Term Disability that have a 60-day waiting period.
#hc110539
-
Quality Systems Specialist
7 days ago
Watertown, United States Ehub Global Inc Full timeTitle: Quality Systems Specialist 6-12 month contract Schedule: Mon-Fri (HYBRID onsite Tues-Thurs) KEY AREAS OF JOB ACCOUNTABILITY:(list of key objectives and quantifying standards) The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring...
-
Director, Quality Systems and Compliance
3 days ago
Watertown, United States ElevateBio Full timeElevateBio is a technology-driven cell and gene therapy company, accelerating access to the cutting-edge technologies and expertise to change the future of medicine. Our integrated technologies model offers turnkey scale and biotechnological capabilities to power genetic medicines processes, programs, and companies to their full potential. The Role: The...
-
Associate Director, Quality Systems
3 days ago
Watertown, United States Affini-T Full timeAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a "best-in-class" TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant diseases. Through the application of...
-
Associate Director, Quality Systems
4 weeks ago
Watertown, United States Affini-T Full timeJob DescriptionJob DescriptionAbout Affini-T Therapeutics Affini-T Therapeutics is an emerging biotechnology company focused on targeting oncogenic driver mutations with a “best-in-class” TCR therapy platform. Our innovative method of discovering high affinity TCRs specific to oncogenic driver mutations is used to develop therapies against malignant...
-
Director, Early Talent Recruitment
4 days ago
Watertown, United States Thermo Fisher Scientific Full timeJoin our team as the Director of Early Talent Recruitment, a pivotal role reporting directly to the Vice President of Talent Acquisition. You'll spearhead our global Early Talent hiring strategies, collaborating closely with our Talent Acquisition pe Talent, Director, Talent Acquisition, Business Partner, Recruiting, Manufacturing, Administrative
-
Design Quality Engineer
3 days ago
Watertown, United States WiTricity Full timeWiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and improve the quality and reliability of WiTricity's products and product development process, drive risk mitigation...
-
Real World Evidence-Associate Director
3 days ago
Watertown, United States AstraZeneca, plc Full timeGaithersburg, MD or Waltham, MA - Join AstraZeneca, a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the worlds most serious disea Director, Evidence, Associate, Clinical, Healthcare, Data Scientist
-
Design Quality Engineer
2 weeks ago
Watertown, United States WiTricity Full timeJob DescriptionJob DescriptionWiTricity is seeking an experienced Design Quality Engineer at our Watertown, MA headquarters to join our Global Engineering and Quality team. This role will work closely with our global product development and manufacturing teams to ensure and improve the quality and reliability of WiTricity’s products and product development...
-
VP, Regulatory Affairs
3 weeks ago
Watertown, United States Vigil Neuroscience, Inc. Full timeVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
-
VP, Regulatory Affairs
1 week ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the worlds first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brains immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
-
VP, Regulatory Affairs
3 weeks ago
Watertown, United States Vigil Neuroscience, Inc. Full timeJob DescriptionJob DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across...
-
VP, Regulatory Affairs
2 weeks ago
Watertown, United States Vigil Neuroscience, Inc. Full timeJob DescriptionJob DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. We are utilizing the tools of modern neuroscience drug development across...
-
VP, Regulatory Affairs
2 weeks ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
-
VP, Regulatory Affairs
2 weeks ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
-
VP, Regulatory Affairs
2 weeks ago
Watertown, United States Vigil Neuroscience Full timeVigil Neuroscience is the world’s first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain’s immune system. We are utilizing the tools of modern neuroscience drug development across multiple therapeutic modalities to...
-
Quality Engineering Supervisor
3 weeks ago
Watertown, United States Twin Cities Orthopedics Full timeDon't swipe left on TCDC! Here's why; at TCDC you are not a number - you are part of a team that owns its future! TCDC is an employee-owned company with over 100 years in business and three locations. We value our employee-owners and their contributions that play an important part in our ability to provide our customers with precision aluminum and magnesium...
-
Watertown, United States Planet Pharma Full timeLocation: Waltham, MA - 3 days / week onsite Salary: AD - $175K + 20% bonus; Director - $200K+ 22% Bonus Top Skills Proven ability to lead Trial Master File (TMF) strategy, streamline processes, oversee vendor management, and ensure inspection readiness. Strong background in managing vendors effectively. Extensive experience with inspection readiness and...
-
Director of Operations
3 weeks ago
Watertown, United States AgCareers.com Full timeCompany: Glacial Lakes Energy (GLE) The Director of Operations will oversee the production management in Glacial Lakes Energy (GLE) affiliated facilities. This role is responsible for identifying, developing and managing process improvement methodologies and facilitates the definition of new and/or improved operational processes within GLE to meet new...
-
Sr Director, Merchandise Planning
3 weeks ago
Watertown, United States Wolverine Worldwide Full time**Success Profile** Check out the top traits we're looking for and see if you have the right mix. * Collaboration * Consumer-Obsessed * Building an Inspiring Culture * Technological savvy * eCommerce Business Acumen "In my role, I am responsible for collaboration with all cross-functional partners to manage all aspects of the eCommerece business, including...
-
Senior Quality Engineer
3 weeks ago
Watertown, United States CareerBuilder Full timeSenior Quality Engineer - Automation page is loaded Senior Quality Engineer - Automation Apply locations Waltham, MA time type Full time posted on Posted Yesterday job requisition id R22043 SS&C is a global provider of investment and financial services and software for the financial services and healthcare industries. Named to Fortune 1000 list as top U.S....