• Merck & Co. (Rahway, NJ)
    …activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities . Supported Areas The ... Job DescriptionPosition Description : Director -Automation Leader (M3)The Enabling Facilities (EF) group... investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsProficient in MS… more
    HireLifeScience (03/26/24)
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  • Merck & Co. (North Wales, PA)
    …Systems for seamless integration and realize synergies where available while ensuring compliance to GMP requirements.- Ensure alignment to corporate policies as ... Division QMS team for QMS updates as needed.Support establishment of New Modalities Global Quality Management processes and Regulatory Compliance plan in support… more
    HireLifeScience (03/29/24)
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  • Catalent (Harman, WV)
    POSITION SUMMARY The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... and timely resolutionResponsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of… more
    HireLifeScience (03/27/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …effective communications within the GPT, by interacting with other GxP QA functions ( GMP / IMP QA, Audit Compliance , Quality Management System [QMS] QA, PV/MA ... people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality… more
    HireLifeScience (02/24/24)
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  • Insmed Incorporated (Bridgewater, NJ)
    …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director Quality GMP Compliance , the Director , Quality ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...suppliers. Using influence, active engagement, and an understanding of compliance requirements, work with critical suppliers to ensure quality,… more
    HireLifeScience (03/12/24)
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  • Daiichi Sankyo, Inc. (Basking Ridge, NJ)
    …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... areas centered around rare diseases and immune disorders.Summary The Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry,… more
    HireLifeScience (03/01/24)
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  • Merck & Co. (Rahway, NJ)
    …role may support facility operations, process development activities, support compliance investigations/change management, author GMP documentation and ... compliance investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsExperience in Process Hazard Analysis (PHA)… more
    HireLifeScience (03/24/24)
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  • Merck & Co. (Rahway, NJ)
    compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.Additional Supported AreasAs required ... compliance investigations and change management.Familiarity with US and EU GMP and Safety compliance regulationsEffective interpersonal and communication… more
    HireLifeScience (03/13/24)
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  • Merck & Co. (Durham, NC)
    …and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment and safetyTactical ... and business plan; receives guidance and oversight from Operations Associate Director and Director ;Interprets client and/or customer needs and assesses… more
    HireLifeScience (03/27/24)
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  • Merck & Co. (Rahway, NJ)
    …and maintenance activities facility operations, process development activities, support compliance investigations/change management, and author GMP documentation ... Development and Maintenance (EDM) Facility Specialist Engineering position will report to the Director , Engineering and will be a member of the EF Team at the… more
    HireLifeScience (03/15/24)
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  • Merck & Co. (Durham, NC)
    …Periodically reviews automation documents, preventive maintenance, and SOPs to ensure compliance with GMP and safety.Assisting in the development and ... implementations of process change control, Delta V Network and troubleshooting in compliance with system life cycle (SLC), GMP , Data integrity, safety,… more
    HireLifeScience (03/22/24)
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  • Merck & Co. (Rahway, NJ)
    …responsibility. The Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... systems and equipment utility metering systems.-This role will collaborate with Global Workplace Enterprise Solutions (GWES) in prioritizing a portfolio of… more
    HireLifeScience (03/20/24)
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  • Takeda Pharmaceutical (Lexington, MA)
    …and cross-functional teams occasionally.You will report to The Associate Director of QC Support.How you will contribute:Influence the organizational control ... Specification (OOS) and Out of Trend (OOT) and unexpected events. Monitor GMP investigations progress and support process to closure. Escalate conflicts that… more
    JobGet (03/28/24)
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  • Associate Director , GMP Operations…

    Gilead Sciences, Inc. (Foster City, CA)
    …accountable for refining QC procedures across Gilead's biologics manufacturing network, ensuring global cGMP compliance . The Associate Director collaborates ... countries worldwide, with headquarters in Foster City, California. **Responsibilities:** The Associate Director , GMP Operations and Logistics, is vital for the… more
    Gilead Sciences, Inc. (03/12/24)
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  • GMP Technical Biopharma Trainer

    Astellas Pharma (Westborough, MA)
    …and Scope:** The GMP Technical Trainer role typically reports to the Director or Sr. Director , Manufacturing Science and Technology and is responsible for ... GxP personnel, coordinating cross-functional training, maintaining oversight and execution of GMP training to maintain operator proficiency and compliance . The… more
    Astellas Pharma (03/13/24)
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  • Director , Quality Systems…

    Bristol Myers Squibb (Devens, MA)
    …in a sterile, biologics or cell therapy commercial manufacturing facility + Expertise in GMP compliance , Quality System and global GMP regulations; ... processes to meticulously affirm control. We're currently seeking a Director of Quality Systems & Compliance at...requirements. + Provides training programs for auditing and various GMP compliance topics. + Serves as a… more
    Bristol Myers Squibb (01/30/24)
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  • Associate Director - QA Site…

    Lilly (Durham, NC)
    …better for people around the world. **Position Description:** The Quality Assurance Compliance Associate Director is the site Quality representative who, ... of management system requirements throughout the organization. The QA Compliance Associate Director is also responsible for...teams management + Build a diverse and capable site compliance organization linked to the Lilly global more
    Lilly (01/19/24)
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  • Senior Director , Global Facilities…

    Bristol Myers Squibb (Summit, NJ)
    …to address technical issues. + Ensure IFM decisions comply with EHS and GMP /Quality requirements. + Collaborate with the Global Capital Project Engineering team ... personal lives. Read more: careers.bms.com/working-with-us . **Business Unit Overview:** Our Global Facilities Operations (GFO) team is responsible for the safe,… more
    Bristol Myers Squibb (03/08/24)
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  • Director , Quality and Compliance

    Boehringer Ingelheim (St. Joseph, MO)
    …benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Director , Quality and Compliance will provide strategic leadership and ... oversight of the Quality & Compliance for global vaccine manufacturing and product...internal audits and regulatory inspections for the site. The Director , Quality and Compliance provides leadership and… more
    Boehringer Ingelheim (02/21/24)
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  • Director , Automation Leader

    Merck (Rahway, NJ)
    …activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities. **Supported Areas** The ... **Job Description** **Position Description** **: Director -Automation Leader (M3)** The Enabling Facilities (EF)...and change management. + Familiarity with US and EU GMP and Safety compliance regulations + Proficient… more
    Merck (03/26/24)
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