Current jobs related to Senior Manager, TMF Quality Assurance - Princeton, New Jersey - Moderna Therapeutics
-
Princeton, New Jersey, United States ACADIA Pharmaceuticals Full timeAbout Acadia PharmaceuticalsAcadia Pharmaceuticals is a leading biopharmaceutical company dedicated to developing innovative treatments for central nervous system disorders. With a strong commitment to advancing breakthroughs in neuroscience, we strive to elevate life for individuals affected by these conditions.Job SummaryWe are seeking a highly qualified...
-
Associate Director, TMF Management
1 month ago
Princeton, New Jersey, United States ACADIA Pharmaceuticals Full timeAbout Acadia PharmaceuticalsWe are a leading biopharmaceutical company dedicated to developing innovative treatments for central nervous system disorders. With a strong commitment to advancing breakthroughs in neuroscience, we strive to elevate life for those affected by these conditions.Our team is passionate about delivering high-quality solutions that...
-
Senior Quality Assurance Specialist
2 weeks ago
Princeton, New Jersey, United States Thinkbyte Consulting Inc Full timeKey Responsibilities:As a Senior Quality Assurance Specialist at Thinkbyte Consulting Inc, you will be responsible for participating in the execution of the testing process in compliance with the Quality Assurance testing plan. This includes managing, enhancing, and updating proprietary automated testing tools and environments to ensure smooth operation.Test...
-
Princeton, New Jersey, United States Kyowa Kirin, Inc. Full timeKyowa Kirin, Inc. is a global specialty pharmaceutical company that applies cutting-edge biotechnologies to discover and deliver innovative medicines in four key areas: bone and mineral disorders, intractable hematologic diseases, hematology oncology, and rare diseases.As a Senior Manager, Pharmaceutical Statistical Programming and Data Operations, you will...
-
Senior Software Quality Assurance Analyst
1 week ago
Princeton, New Jersey, United States State Street Corporation Full timeJob SummaryWe are seeking a talented Senior Software Quality Assurance Analyst to join our agile team at State Street Corporation. As a key member of our technology function, Global Technology Services (GTS), you will play a crucial role in ensuring the quality and reliability of our software products.Key ResponsibilitiesCollaborate with cross-functional...
-
Senior Software Quality Assurance Analyst
3 weeks ago
Princeton, New Jersey, United States State Street Full timeJob Title: Senior Software Quality Assurance AnalystWe are seeking a highly skilled Senior Software Quality Assurance Analyst to join our agile team. As a key member of our technology function, Global Technology Services (GTS), you will play a crucial role in ensuring the quality and reliability of our software products.Key Responsibilities:Collaborate with...
-
Princeton, New Jersey, United States Bristol-Myers Squibb Full timeJoin Our Team as a Clinical Quality Assurance LeaderBristol Myers Squibb is seeking a highly skilled Clinical Quality Assurance Leader to join our R&D Quality team. As a key member of our leadership team, you will be responsible for ensuring the highest standards of quality and compliance in clinical research and related activities.Key...
-
Quality Assurance Specialist
3 weeks ago
Princeton, New Jersey, United States Thinkbyte Consulting Inc. ( E-Verified ) Full timeQuality Assurance Analyst Job DescriptionAt Thinkbyte Consulting Inc. (E-Verified), we are seeking a highly skilled Quality Assurance Analyst to join our team. The successful candidate will be responsible for ensuring the quality of our software products by designing, implementing, and executing comprehensive testing strategies.Key Responsibilities:Testing...
-
Director, Quality Assurance
1 month ago
Princeton, New Jersey, United States TAIHO ONCOLOGY INC Full timeDirector, Quality AssuranceTaiho Oncology is seeking a highly experienced Director, Quality Assurance to lead our GCP Quality Assurance function. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our clinical trials.Key Responsibilities:Lead GCP Quality Assurance initiatives across the Taiho...
-
Princeton, New Jersey, United States Kyowa Kirin, Inc. Full timeJob SummaryKyowa Kirin, a global specialty pharmaceutical company, seeks a Senior Manager, Pharmaceutical Statistical Programming and Data Operations to oversee vendor management and ensure high-quality deliverables for clinical trials and regulatory submissions.Key ResponsibilitiesDevelop TLF shells, CDISC deliverables, and TLFs in collaboration with...
-
Senior Software Quality Assurance
4 days ago
Princeton, New Jersey, United States State Street Full timeAbout the RoleWe are seeking a talented Senior Software Quality Assurance (SQA) Analyst to join our agile team at State Street. As a key member of our technology function, Global Technology Services (GTS), you will play a crucial role in ensuring the quality and reliability of our software products.Key ResponsibilitiesCollaborate with cross-functional agile...
-
Quality Assurance Specialist
1 week ago
Princeton, New Jersey, United States Path Engineering Full timeJob SummaryAs a Quality Control Technician at Path Engineering, you will be responsible for ensuring the quality of our products and processes. This involves providing quality control across various departments, ensuring compliance with company's GMPs, HACCP plan, SSOP programs, and quality policies.You will also assist the Quality Assurance Manager with the...
-
Senior Clinical Trial Associate
4 days ago
Princeton, New Jersey, United States Genmab Full timeAt Genmab, we're committed to building extraordinary futures together, by developing innovative antibody products and pioneering therapies that change the lives of patients and the future of cancer treatment and serious diseases.Our team is passionate about our purpose and genuinely cares about our mission to transform the lives of patients through...
-
Director, Quality Assurance Lead
4 weeks ago
Princeton, New Jersey, United States TAIHO ONCOLOGY INC Full timeJob Title: Director, Quality AssuranceJoin TAIHO ONCOLOGY INC as a Director, Quality Assurance, and lead quality initiatives across the Taiho clinical development portfolio. As a key member of the GCP Quality Assurance Team, you will provide expert GCP regulatory guidance and advice to all development teams in support of Tiaho's commitment to excellence in...
-
Quality Assurance Associate
4 weeks ago
Princeton, New Jersey, United States Food Lion Full timeJob Title: PT Quality Assurance AssociateFood Lion is seeking a Part-Time Quality Assurance Associate to join our team. As a Quality Assurance Associate, you will play a critical role in ensuring our stores meet the highest standards of quality and safety.Key Responsibilities:Maintain a clean and safe shopping environment for our customersMinimize shrink...
-
Quality Assurance Specialist
2 weeks ago
Princeton, New Jersey, United States dsm-firmenich Full timeJob Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at dsm-firmenich. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for implementing quality control measures to prevent defects and errors.Key Responsibilities:Support the...
-
Senior Quality Executive for R&D
3 days ago
Princeton, New Jersey, United States Bristol-Myers Squibb Company Full timeAbout the RoleThis is a senior leadership position responsible for overseeing the quality and compliance of R&D activities across the organization. The successful candidate will have a strong background in quality assurance and regulatory affairs, with experience in managing cross-functional teams and developing strategies to ensure compliance with relevant...
-
Quality Assurance Specialist
4 days ago
Princeton, New Jersey, United States dsm-firmenich Full timeJob Title: Quality Assurance SpecialistAbout the Role:As a Quality Assurance Specialist at dsm-firmenich, you will play a vital role in ensuring the quality of our products and services. Your primary responsibility will be to perform Quality Assurance activities in line with Global driven Policies and Procedures.Key Responsibilities:• Support the MQI team...
-
Quality Assurance Specialist
2 weeks ago
Princeton, New Jersey, United States Schlage Lock Company LLC Full timeUnlock Your Potential as a Quality Engineer InternAt Allegion, we're committed to creating peace of mind for our customers. As a Quality Engineer Intern, you'll be part of a team that ensures exceptional customer experiences. You'll work closely with our Quality Function team to resolve issues and prevent them from occurring through data analysis and process...
-
Senior Risk Assurance Expert
1 day ago
Princeton, New Jersey, United States Munich Re America Services Full timeThe OpportunityMunich Re America Services is seeking a highly skilled Senior Risk Assurance Expert to join our team. This exciting opportunity will allow you to utilize your analytical skills and business acumen to lead audits and identify errors and omissions in the accounting and reporting requirements of reinsurance contracts.As a Senior Risk Assurance...
Senior Manager, TMF Quality Assurance
2 months ago
The Role:
The Clinical Trial Systems Operations (CTSO) division at Moderna is seeking a proactive, detail-oriented, and seasoned leader to oversee quality assessments of trial master files (TMF) and associated documentation across clinical studies. This role is crucial in ensuring that TMFs comply with regulatory standards and align with Moderna's oversight requirements, including audits and external inspections.
The ideal candidate will possess a meticulous approach and a flexible, solution-driven mindset, enabling them to effectively support both internal team members and our contract research organization (CRO) partners.
Key Responsibilities:
Functional Team Leadership
Manage a team of TMF Quality Review Associates responsible for conducting regular assessments of trial TMF content for quality and completeness.
Ensure that periodic reviews are scheduled and executed according to the trial TMF Plans.
Evaluate the team's output for quality, addressing any deficiencies through remediation strategies such as additional training or new tools.
Provide constructive performance feedback as necessary to functional service provider team members.
Collaborate with colleagues in CTSO to ensure uniform execution of periodic completeness reviews across the trial portfolio.
Work closely with the Associate Director of Clinical Records Management to comprehend requirements for periodic completeness review activities and contribute ideas for process and tool enhancements.
Participate directly in periodic completeness reviews to apply firsthand knowledge of processes and tools.
Engage in CTSO leadership meetings and attend departmental and trial-specific discussions as required.
Perform additional TMF document-related tasks as directed by the Director of Clinical Trial Systems Operations.
Qualifications:
Bachelor's degree required. A minimum of 6 years of experience in a clinical research setting within the pharmaceutical or biotech industry is essential. At least 4 years of experience in TMF document management, with a focus on TMF completeness and quality oversight, is preferred.
Prior experience in team management is advantageous.
Excellent communication skills, both clear and timely.
Proficient understanding of clinical research documents, their content, and purpose.
Familiarity with ICH/GCP guidelines and other relevant regulatory standards.
Strong organizational and prioritization skills to manage workload effectively, with a keen attention to detail.
Demonstrated proficiency with electronic TMF applications.
Benefits:
Moderna offers a comprehensive and innovative benefits package, including:
- Highly competitive medical, dental, and vision coverage options
- Flexible Spending Accounts for medical and dependent care expenses
- Lifestyle Spending Account funds for personal enrichment and self-care
- Family care benefits, including subsidized backup care and on-demand tutoring
- Free premium access to fitness, nutrition, and mindfulness classes
- Exclusive discounts on fitness equipment
- Generous paid time off, including vacation, sick leave, and holidays
- Paid sabbatical after 5 years of service
- Comprehensive parental leave policy
- 401k matching and financial planning resources
- Complimentary concierge services for various needs
At Moderna, we are committed to fostering a culture of belonging and inclusivity, recognizing that diverse experiences and perspectives drive our success. We are proud to be an equal opportunity employer, dedicated to creating a workplace where everyone can thrive.
