- Catalent (San Diego, CA)
- Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical ... regulatory compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and ... in support of a proactive quality risk management process. Interact with the audit function. The respective Data Management groups and respective CROs in order to… more
- Contract Pharmacal Corp (Hauppauge, NY)
- Senior Manager ; QA Compliance (Audits) Hauppauge, NY (http://maps.google.com/maps?q=135+Adams+Avenue+Hauppauge+NY+11788) * Quality Assurance Apply Description ... Position Summary: The Sr. Manager of Quality Assurance Compliance - Audits has primary...the Document Control team and facility compliance to support audit functions. Responsibilities:Responsibilities include, but are not limited to:… more
- HistoWiz (Long Island City, NY)
- …into GLP to support our customers' growing histology needs. Who are you? The Senior Manager /Director of Quality is responsible for overseeing the quality and ... accountable for the execution of assigned company GLP QA audit activities ensuring that the current regulations, policies, and...aims to build from the ground up, not just audit . GENERAL RESPONSIBILITIES AND SPECIFIC DUTIES + Develop, review… more
- Charles River Laboratories (Shrewsbury, MA)
- Senior Laboratory Manager Req ID #:...maintained in a clean and orderly condition, presenting as audit ready at all times. ⦁ Oversee the development, ... the primary contact, prepare for and participate in customer audits. Respond to audit findings in a timely fashion. Initiate corrective action, provide support and… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- As a Senior Project Manager - Oncology, you will be responsible for the routine cross-functional operations of assigned studies for one or more clients or ... + Coordinate, plan and execute Investigator Meetings as needed. May need support from a Senior Project Manager . + Lead internal project team meetings. + May lead… more
- Catalent Pharma Solutions (San Diego, CA)
- ** Senior Manager , Quality Assurance** **Position Summary:** **Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at ... regulatory compliance, and sound fiscal responsibility. The primary responsibilities of the Senior QA Manager include activities related to GMP (Good… more
- Novo Nordisk (Lexington, MA)
- …to develop new medicines for patients. The Position We are looking to hire a Senior Clinical Project Manager (CPM). This is a unique opportunity to work in ... programs based on an innovative RNAi technology platform. The Senior CPM will be responsible for all aspects of...the Trial Master File (TMF) and assist with periodic audit of the TMF + Drive critical clinical trial… more
- BeiGene (Emeryville, CA)
- …in the region and provides regular updates on study progress in the region to senior management and Global Clinical Study Manager as required + Represents the ... of the Clinical Study Report in collaboration with Global Clinical Study Manager and Medical Writing **Quality:** + Handles escalated issues or problems with… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Manager Clinical Operations Date: Mar...for assigned studies to ensure timely resolution of CQA audit findings at the global study or program level ... and new people to make a difference with. **The opportunity** The Sr. Manager is responsible to lead and oversee the operational execution of Teva's clinical… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …and passionate professionals who collectively propel us to new horizons. The ** Senior Manager , Quality Operations ExM Americas** manages CMO relationships from ... audits as defined in related Quality Agreements + Assist with preparation of audit observations + Participate in audits (For Cause) of North American External… more
- Actalent (Bernardsville, NJ)
- …deviations, and suspected serious non-compliance by sites Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to ... CAPAs as required Close out: Supervising study close-out activities and contributing to clinical study report writing and review Additional Skills & Qualifications: Bachelors Degree 8+ years of experience LEADING GLOBAL Clinical trials within Pharma Industry… more
- Boehringer Ingelheim (Ridgefield, CT)
- …This role ensures thereby a compliant execution of the QM global annual audit program. The Sr. AD, Global Principal QM Auditor oversees assigned specific product ... strategy and process in liaison with the respective line manager . The incumbent will act as subject matter expert...+ Prepares complex global internal and external audits (all audit types including process, systems, partner and supplier audits)… more
- Catalyst Clinical Research LLC (Raleigh, NC)
- As a Senior Clinical Research Associate with strong Car-T/Cell therapy experience, you will monitor clinical trial programs and manage regional clinical trial sites ... input on site selection, study initiation procedures, conflict resolution, and audit responses. You will effectively communicate all relevant and important findings… more
- United Therapeutics (Durham, NC)
- …clinical team in preparing for external audits + Facilitate GXP Compliance/QA audit activities for clinical development to include root cause analysis, corrective ... in biopharmaceutical research & development or CRO + For Senior Oversight Lead level: + 10+ years of experience...relevant clinical oversight experience as a CRA and/or Clinical Manager in the biopharmaceutical industry + Experience with quality… more
- Highmark Health (Washington, DC)
- …contact with pharmaceutical manufacturers and vendors, including the Pharmacy Benefit Manager . This role may ensure compliance with government drug rebate reporting ... obligations and may assist in audit responses. This role may support monitoring FDA-approvals, drug...business + Experience in a Health Plan, Pharmacy Benefit Manager (PBM), or Pharmaceutical Manufacturer environment + 2 years… more
- Danaher Corporation (Chaska, MN)
- …a part of the CCIA Clinical Affairs team and report to the Clinical Affairs Manager , who is responsible for managing the clinical operations for a cardiac study. If ... (SSF), and Investigator Site Files (ISF) are maintained and kept current; assist in audit readiness and preparation. + Contribute to case report form design and EDC… more
- BeiGene (San Mateo, CA)
- …study-specific monitoring issues * Provide direct support to the Clinical Study Manager by assisting with monitoring visit report review and other managerial tasks ... audits/inspections preparation/responses and quality issues, as needed, and follow-through with audit /inspection findings to resolution as it related to involved CRA… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …risks. + Prepare, revise, and execute vendor Quality Agreements + Communicate audit results to senior management and regulatory authorities when necessary. ... quality management systems, manufacturing processes and facilities. + Develop comprehensive audit plans, including scope, objectives and risk assessment. + Conduct… more
- Nanobiosym, Inc. (Cambridge, MA)
- …help the company scale up its operations. Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role and requirements are below. ... The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the Nanobiosym diagnostic testing laboratory.T… more