ICH Q7 Jobs in USA

Clinical Trial Manager Boston We are working on behalf of our client to find a Clinical Trial Manager based in Boston to lead global earlyphase clinical trials in a dynamic environment. The role involves managing trials from startup to closeout ensuring deliverables are met on time an More...

FillFinish Subject Matter Expert (SME) Job Location: Beloit Wisconsin Day 1 Onsite (Candidate needs to work 4 Days at the Client Office) seeking an experienced FillFinish Subject Matter Expert (SME) to support the commissioning and startup of a new GMPcompliant fillfinish facility for More...

Title: QC Microbiology Analyst Location: Miami FL Onsite experience need : 6years TOP QUALITIES INCLUDE: Thorough knowledge and understanding of current Good Manufacturing Practices (cGMP) FDA Guidance and ICH Guidelines Strong microbiology skills with a focus on drug product c More...

Title: QC Microbiology yst Location: Miami FL Onsite experience need : 6years JD: Thorough knowledge and understanding of current Good Manufacturing Practices (cGMP) FDA Guidance and ICH Guidelines Strong microbiology ss with a focus on drug product contamination control and e More...

Director Statistical Programming Were seeking a Director of Statistical Programming to lead statistical programming activities for clinical development programs and manage vendor oversight. This role will collaborate closely with biostatisticians data managers and crossfunctional team More...

Job Title: Application Lead (SAP Advanced Track and Trace for Pharmaceuticals) Location: 100% Remote Duration: 6 Months Contract Interview mode: Video Visa: USC/GC/GCEAD/H4EAD/TN LinkedIn (Required) Job Description: As an Application Lead you will take charge of designing bu More...

Director Clinical Operations Boston We are working on behalf of our client to find a Director of Clinical Operations based in Boston. This leadership role involves managing oncology trials overseeing daytoday operations and working closely with both internal teams and external partner More...

Director of Biostatistics In this role reporting to the Vice President of Biometrics you will work with crossfunctional clinical teams overseeing statistical activities across clinical programs including managing statistical deliverables outsourced to CROs. This is an exciting opportu More...

Role: Application Lead (SAP Advanced Track and Trace for Pharmaceuticals) Location: Remote (Anywhere in North America or LATAM) Duration: 6 Months Job Description: Work Hours: Flexible 12:00 AM start time Visa Restrictions: None Industry: US FDA and Drug Supply Chain experience requir More...

POSITION DESCRIPTION Position Title: Quality Control Chemist Department: Quality ControlReports To: Supervisor of Quality Control Work Location: Decatur IllinoisPosition Summary:Perform the sampling of raw materials chemical and physical ysis of raw materials bulk formulations finishe More...

Job Title Validation Process Monitoring and Data Analytics Location Parsippany NJ Job Duration: 12 months Hybrid Onsite T/W/Th Working hours: 84:30 8:305 95:30 type of hours (most of team works 95) Responsibilities: Process Engineer/Validation Engineer having strong backgrou More...

Our client is a leading biopharmaceutical company dedicated to developing therapies to better their patients lives and driven by an entrepreneurial mindset and a teamoriented culture. Position Overview The Vice President of Regulatory will oversee all aspects of Regulatory operations. More...

Job Title Process Monitoring and Data Analytics Location Parsippany NJ Hybrid Onsite T/W/Th Working hours: 84:30 8:305 95:30 type of hours (most of team works 95) Responsibilities: Process Engineer/Validation Engineer having strong background in statistics process monitori More...

Position Process Engineer Location Parsippany NJ 07054 (Hybrid) Duration 12 months Shift 84:30 8:305 95:30 type of hours (most of team works 95) Responsibilities: Process Engineer/Validation Engineer having strong background in statistics process monitoring and advanced statistic More...

This is a remote position. Position: Clinical Research ociate (CRA) Cardiovascular Location: Remote (applicant should be willing to travel as needed) Job Overview:We are seeking a dedicated and detailoriented Clinical Research ociate (CRA) with a strong background in cardiovas More...

Summary:The Clinical Program Director is a fulltime role responsible for overseeing clinical operations program development and mental health initiatives. This position ensures highquality patient care and treatment outcomes through leadership and collaboration with medical staff.Resp More...

Hi Hope all is well Please revert me with your updated profile if you like this JD to apply Quality Systems Specialist Hybrid role in Waltham MA ( Local only) Duration 5 months (with extension possible) Must Have vs. Plus 23 years exp. In biotech or regulated industry (require More...

DIRECTOR/SENIOR DIRECTOR OF REGULATORY CHEMISTRY MANUFACTURING AND CONTROLS (CMC)Company Overview:Mythic Therapeutics is a privately held clinical stage productplatform company building a pipeline of bestinclass antibody drug conjugates (ADCs) exhibiting a combination of unprecedented More...

Job Title: CMC Expert Biologics Location: Hybrid (NJ Boston) Job Description: We are seeking a CMC Expert specializing in Biologics to provide regulatory and lifecycle management support for a large client. This role is instrumental in fulfilling client needs for regulatory submissi More...

QA Manufacturing Specialist II (Hopewell NJ) Need with 45 years experienced only. Background: Our client is looking for QA Manufacturing support to assist in the ramp up of their new R&D facility in New Jersey. Project: Supports QA manufacturing activities in the Warehouse More...