- Regeneron Pharmaceuticals (Rensselaer, NY)
- …with in compliance. The Director will also provide support during regulatory inspections and internal audits and work to ensure that all identified content ... inspection readiness. + Identify trends in recent regulatory inspections and translate this to recommendations to improve readiness....biotech industries or related field, for each level: + Associate Director - 10+ years + … more
- Merck (Columbus, OH)
- … Inspection Preparation and Management + Responsible for maintaining current regulatory inspection knowledge as it relates to GCP inspections by regulatory ... TA. Maintain contemporaneous awareness of filing schedules, potential future inspections and ongoing inspection preparation activity. +...+ Ensures that all actions and commitments related to audits and inspections are implemented in a… more
- Amicus Therapeutics (Princeton, NJ)
- Associate Director , External Quality Lead (Small Molecule) Location Princeton, NJ Requisition ID 2258 # of openings 1 Apply Now ... (https://phh.tbe.taleo.net/phh04/ats/careers/v2/applyRequisition?org=AMICUS&cws=37&rid=1303) Associate Director , External Quality Lead (Small Molecule) Amicus… more
- GRAIL (Durham, NC)
- …partnerships with pharmaceutical companies for companion diagnostic (CDx) tests. The Associate Director will work cross-functionally to manage Grail's Clinical ... as needed + Assist in the hosting of inspections and audits ; creating responses to audit...ensure resolution; and identifying lessons learned + Lead GCP Inspection Readiness activities for study teams and supporting departments… more
- Actalent (Jersey City, NJ)
- Our client is seeking an Associate Director or Director of Clinical QA to join their group. Main Responsibilities + Lead and provide overall quality ... + Perform risk assessments to identify audit targets, conduct internal and vendor audits , develop and maintain audit tools, checklists and plans, and author or… more
- Lilly (Lebanon, IN)
- …drives and enhances organizational capabilities and ensures personnel qualification. The Associate Director is responsible for enhancing employees' capabilities ... delivery of training meet corporate and site quality standards. Additionally, the Associate Director will oversee performance consulting for business partners to… more
- IQVIA (Seattle, WA)
- …stakeholders as agreed, as assigned * Oversee proper coordination of customer-initiated audits and mock regulatory inspections , manage regulatory facility ... assigned QA program in support of customer accounts, functional accounts, audit and inspection program, or QA quality management system at a regional and/or global… more
- MTA (New York, NY)
- Associate Director Facility Operations Job ID: 6090 Business Unit: MTA Headquarters Location: New York, NY, United States Regular/Temporary: Regular Department: ... Acquisitions & RE Ops Date Posted: Apr 24, 2024 Description JOB TITLE : Associate Director , Facility Operations (North) SALARY RANGE : $125,000 - $140,000 HAY… more
- Merck (Columbus, OH)
- …on time, every time, across the globe. **Position Responsibilities:** + The Associate Director is responsible for performing comprehensive and detailed GMP ... compliance audits of human health sites, animal health sites, contractors,...+ Prior experience at a health authority performing GMP inspections . + Demonstrated ability to establish and maintain collaborative… more
- Kelly Services (Burlington, MA)
- **Sr. Manager/ Associate Director - Quality Assurance** **Burlington, MA** **Direct Hire** **Compensation: $125k-165k base + 10-15% annual bonus** **Candidate ... + Ensure appropriate definition, development, and implementation of Quality systems. + Conduct inspections and internal audits in accordance with GCP, GLP and… more
- Catholic Charities Family Community Services (Rochester, NY)
- ** Associate Director of Housing** **Job Details** **Level** Management **Job Location** Son House - Rochester, NY **Position Type** Full Time **Education Level** ... Don't miss out on being a part of something special! **Position Title:** Associate Director of Housing Services **Salary Range: $60,000 annually to $66,000.00… more
- Sanofi Group (Ridgefield, NJ)
- The Associate Director Quality is part of the Quality Assurance Department at Ridgefield, NJ. This role is responsible for providing direction and managing Teams ... direct supervision to deviation / CAPA team, Quality Assurance Inspection Team and Supplier Quality Team to meet Sanofi,...Teams and cross-functional groups related to site operations The Associate Director Quality Compliance is expected to… more
- Lilly (Indianapolis, IN)
- …a wholly owned subsidiary of Eli Lilly and Company. **Position Summary:** The Associate Director of Quality Engineering and Computer System Validation (CSV) is ... Quality Systems related to POINTs Engineering and Computer System Validation processes. The Associate Director of Engineering and CSV will work across the POINT… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Temperature Strategy & Execution - 2406177829W **Description** Johnson & Johnson Innovative Medicine Research & Development (JJIM R&D), part ... of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director , Temperature Strategy & Execution within Clinical Supply Chain (CSC). The… more
- Lilly (Indianapolis, IN)
- …partners, contract manufacturers, and internal business customers. The QA Operations Associate Director position is responsible of the development, management, ... and ensure safety goals are achieved. **Contract manufactures management:** . Support Corporate audits , CM's inspections (as required) and follow up on audit… more
- Lilly (Durham, NC)
- …ground up as a member of the site IT organization. **Responsibilities:** The IT Associate Director -RTP is responsible for the smooth operation of critical IT ... at the Research Triangle Park (RTP) manufacturing site. The Associate Director assists the Senior Director...and ensure privacy compliance. + Facilitate internal and external inspections of IT systems and processes and ensure timely… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …to more patients living with certain difficult-to-treat cancers. The Clinical Pharmacology Associate Director will be the GCLP scientific expert and point ... regulatory submissions and in responding to regulatory queries and audits as needed + Supports regulatory agency inspections...Bachelor's and 10+ years of relevant experience OR + Associate and 12+ years of relevant experience OR +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. **Summary** The Associate Director , External Data Management, is accountable for the ... Ensure consistency of standard implementation across programs. Is accountable for inspection readiness of external data documentation filed/archived in Trial Master… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plans, Clinical Study Reports). + Actively participates in audits and inspections . + Operational Efficiency / Continuous Improvement: ... across multiple therapeutic areas and experience with regulatory submissions and inspections . Finally, this position has strong skills in continuous improvement,… more
- Takeda Pharmaceuticals (Columbus, OH)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible for the ... to support internal and external (ie Regulatory Authority) requirements and support audits / inspections as a labeling subject matter expert + Liaise with… more