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RADcube
Boston, MA, United States
Primary Responsibilities • Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. • Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. • Identify systemic problems, inefficiencies, risks, and opportunities for improvement; work with
Job Source: RADcubeConnect Life Science
Cambridge, MA, United States
Quality Manager Cambridge, MA $135,000 - £145,000 Medical Device The ideal candidate is a critical thinker who will proactively improve the quality systems of our implantable medical device client through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback. Responsibili
Job Source: Connect Life ScienceSyntricatetechnologies
Burlington, MA, United States
Job duties: Develop and execute software tests to identify software problems and their causes. Create test plans, scripts, and test data. Perform product testing, UAT, remote testing, and performance testing. Prepare UAT and functional test cases. Conduct system analysis, and identify and resolve problems. Test design improvements through the
Job Source: SyntricatetechnologiesMotion Recruitment
Boston, MA, United States
Our Client, an E-Learning company focused on providing assessments and personalized instructional materials, are currently looking to bring aboard a Senior Quality Assurance Engineer to their team. As a QA Engineer here, you will be focused on driving their products/platform forward through your experience in testing software development. Technica
Job Source: Motion RecruitmentCHS Inc
Boston, MA, United States
Please note that CHS Inc. has set internal salary ranges for each position within its job matrix. However, CHS Inc. will pay or exceed the prevailing wage, as determined by the U.S. Department of Labor, when applicable. CHS Inc. Senior IT Quality Assurance Analyst Location: Inver Grove Heights, MN Salary range is $114,358 - $136,100 per year J
Job Source: CHS IncDice
Boston, MA, United States
Dice is the leading career destination for tech experts at every stage of their careers. Our client, Motion Recruitment Partners, LLC, is seeking the following. Apply via Dice today! Our Client, an E-Learning company focused on providing assessments and personalized instructional materials, are currently looking to bring aboard a Senior Quality As
Job Source: DiceGardner Resources Consulting
Boston, MA, United States
Our Pharma client, located in Boston, MA, is currently searching for a Senior Quality Assurance Contractor to help maintain quality systems with a focus on GMP Compliance. The Senior QA Contractor will assist with batch record review and will provide a thorough review and analysis of mission critical data focused on QMS trending and reporting and
Job Source: Gardner Resources ConsultingSyntricate Technologies
Burlington, MA, United States
Job duties: Develop and execute software tests to identify software problems and their causes. Create test plans, scripts, and test data. Perform product testing, UAT, remote testing, and performance testing. Prepare UAT and functional test cases. Conduct system analysis, and identify and resolve problems. Test design improvements through the devel
Job Source: Syntricate TechnologiesBoston, MA, United States
Sr. Manager - Quality Assurance, Systems and Compliane
Pay Rate: 65-75 per hour
Norwood, MA
6 month contract
The Role
This role is an exciting opportunity to be a part of the Quality Assurance organization. Moderna is a growing organization with a state-of-the-art cGMP manufacturing facility in Norwood, MA, USA. The site focuses on manufacturing early phase and commercial product. As the company grows, the Quality Assurance is looking for talented individuals with a strong Quality Culture mindset and ability to adapt to a fast-paced environment. This role will be supporting many of the responsibilities listed below and will be expected to collaborate with cross-functional departments to maintain and enhance compliance at the Norwood site.
We work collaboratively as a team, we boldly strive for excellence, we are constantly curious and committed to ongoing learning and improvement, and we are relentless in our pursuit of having the highest level of Quality products.
Here’s What You’ll Do
• Manage the performance and effectiveness of the quality system programs such as risk management, change management, discrepancy and CAPA management, training, documentation and records management, and data integrity via maintenance and execution of Quality Management Review and Site Quality Council governance forums.
• Support the establishment and reporting of quality metrics for cGMP related functional areas.
• Author and review SOPs and Policies to ensure compliance and adherence to regulations/cGMP operations.
• Author, review, and approve Annual Product Quality Reviews (APQR) and other trend reports.
• Partner cross-functionally to maintain a company culture that embraces compliance and recognizes that compliance is a collective responsibility of all company employees.
• Continue to improve Moderna’s overall Quality Management System (QMS) and quality manual, policies and procedures while keeping them current with emerging and changing regulations, guidance documents and current industry best practices and expectations.
• Provide compliance guidance and training through various methods including formal and informal presentations and trainings.
• Identify opportunities for quality system improvements.
• Work collaboratively with the digital team on the GXP integrated digital landscape to support eDOC, eQMS, and LMS systems.
Within 3 Months, You Will…
• Complete required onboarding and training programs, familiarize with company policies, procedures, and quality systems.
• Start developing relationships with key stakeholders.
• Understand the current state of compliance and quality systems.
Within 6 Months, You Will…
• Participate in development of strategic plans for quality system and compliance improvements.
• Establish regular communication channels for updates and feedback.
• Fully own coordination and execution of Quality Management Review and Site Quality Council meetings.
Within 12 Months, You Will…
• Act autonomously to identify compliance risk and continuous improvement opportunities.
• Demonstrate tangible improvements in quality systems and compliance metrics, establish yourself as an influencer within the organization, and contribute to broader organizational goals and initiatives beyond the quality systems and compliance realms.
Here’s What You’ll Need (Minimum Qualifications)
• Bachelor’s degree with a minimum of 10 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.
• Fluent in written and spoken English.
• Experience in data analysis, statistical evaluation, and trending of data.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.
• Ability to interact effectively with all levels of personnel within the organization.
• Ability to navigate through ambiguity and rapid growth and adapt to change.
• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
Here’s What You’ll Bring to the Table (Preferred Qualifications)
• Master’s degree with a minimum of 8 years of experience in the pharmaceutical industries or Ph.D. with a minimum of 5 years of experience in the pharmaceutical industries providing Quality Assurance oversight in a cGMP organization.
• Deep understanding and experience with global cGMP regulations (e.g. FDA, MHRA, EMA, PMDA, ANVISA) and ICH guidelines.
• Advanced experience in data analysis, statistical evaluation, and trending of data.
• Capability to lead and train a diverse, multinational community of practice with multiple stakeholders.
• Proven ability to lead and manage projects/teams of significant scope and complexity, meeting deliverables and timelines (project management skills).
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Email Alert for Senior Quality Assurance Manager jobs in Boston, MA, United States
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