- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. SummaryThis position supports the head of CSPV Quality , Compliance & Training in the establishment, implementation and oversight of ... the CSPV Quality , Compliance and Training function. This position is responsible...key performance indicators (KPIs) and compliance reports relative to safety reporting processes and regulatory authority submissions. This role… more
- Aequor (Devers, TX)
- Top Must Have: Detailed experience with Contractor Safety , Safe Work Permit Program Support EHS training and Risk/Hazard Assessment Initiative/autonomy EHS ... audits EHS program implementation Job Description: Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist) Onsite role--Local candidates only… more
- Catalent (Manassas, VA)
- …if any out of specification or any deviations are found. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standard and any other standard that ... enter and track result data Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP)...BS in Food Science related major with 1+ year experience in quality assurance in a regulated… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …CSPV and key business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements ... lessons learned and improved processes. Provide end to end safety consultation impacting products from a quality ...with senior CSPV/ Medical Affairs leadership teams to ensure Quality is consistently and proactively represented at program… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality Plan status, metrics, trends in deviations and Quality Events, inspection/audit findings, inspection/audit CAPAs).Responsibilities- Leadership/ Program ... around rare diseases and immune disorders. SummarySupport the PVQA quality strategy and quality plan with specialty...with involvement in a regulated GCP environment or equivalent experience preferred- Experience in Clinical Safety… more
- Catalent (Philadelphia, PA)
- …our facilities. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... Quality Assurance Document Control Supervisor Position Summary Catalent...a deep understanding and values around patient and employee safety , will assist in the enforcement of GMPs and… more
- Merck & Co. (North Wales, PA)
- …the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of ... multiple stakeholder groups which include clinical development, outcomes research and safety evaluation.The position is a key collaborator with statistics and other… more
- Merck & Co. (Durham, NC)
- …people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in ... many diverse areas including Biologics, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation. Position… more
- Catalent (St. Petersburg, FL)
- I. Department Overview: The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department has ... the responsibility for Quality aspects related to Quality Systems, Finished...Furthermore, this position will participate in the internal audit program , customer audits and may assist with Supplier Audits/Certification… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …or senior director level, depending on the scope and size of the asset program . This Clinical Science (CS) lead will be responsible for leading and managing one ... or more clinical scientists, oversee a program of clinical trials from the clinical science perspective,...clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... this leader enables all activities related to the successful acquisition of high- quality goods/services at the best possible prices and business terms for NNI.… more
- Catalent (Emeryville, CA)
- …drug conjugates. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and ... related discipline required with 1.5+ years of additional research experience in industry. We would also accept a Master's...to establish and meet production goals that consistently meet quality requirements is essential. Must have a desire and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Master's Degree preferred Experience Qualifications- 4 or More Years Previous experience with a data governance program , data stewardship program ... governance processes surrounding these capabilities, and the data governance program in general. This role will help support the...managers and lineage capabilities. preferred- 4 or More Years Experience with data quality tools eg, Precisely… more
- Merck & Co. (Durham, NC)
- …embraces an inclusive team culture including significant interaction with Operations, Quality , Automation, Technology, and other groups as required.The Lab Senior ... Responsible for supporting our Manufacturing Division,- Divisional site mission by assuring quality of products and services are of the highest quality ,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …role in ensuring governance and continuous improvement as an enabler supporting product quality , patient safety , and data integrity, and contributes to the ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...Nordisk standards. Work to identify efficiencies in the CSV program approach. Work to apply lessons learned, and stay… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial performance and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure actions ... planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Shimadzu Scientific Instruments (Naperville, IL)
- …competitive salary. Retirement Benefits: Matching 401K and a Profit-Sharing Program . Health Benefits: Flexible Spending/Health Savings Accounts. Performance Bonuses: ... Off and Hybrid work options for qualifying roles. Education: Tuition Assistance Program for both graduate and undergraduate levels. Insurance Perks: Pet Insurance,… more
- Novo Nordisk Inc. (Irvine, CA)
- …to make a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety , rights and wellbeing; data reliability; ... find better and more innovative ways to improve their quality of life. We're changing lives for a living....and Closure) for assigned sites and clinical trials Verifies safety reporting and the proper handling, monitoring and storage… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of ... disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one or more indications; Interacts… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Global Development Hub merges biotech speed and agility with large pharmaceutical company quality , resources , and stability, uniting the best of both worlds to ... is a team player, detail oriented with prior research experience , either in academia or industry. In this role,...of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility… more
