- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that ... ingredients (API), biologics, vaccine drug substances and finished products. As Director , you will support Quality audits and health authority inspections… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Summary: -The Director , Combination Product Commercialization is a key leadership role within the Device Development and Technology Organization. ... with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global… more
- City of Spring Hill Kansas (Spring Hill, KS)
- …Brief Description of Duties: Under the supervision of the City Administrator, the Director of Community Development is an exempt position under FLSA. Ensuring that ... planning and development function as well as codes and building inspection . This employee should possess excellent communication, organizational, and public relation… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... North America (NA) Clinical Quality Assurance (CQA) strategy including audit and inspection management and oversight of the Quality management system. This role is… more
- Merck & Co. (Durham, NC)
- …safest and most compliant operation around the network.EMSS has an Associate Director opening for the Bulk Facility (GBF) maintenance team. The selected candidate ... demonstrated experience of interacting with site, divisional or regulatory audits/ inspections .Good oral and written communication skillsProject management, including change… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... input on and authors SOPS, SOIs, and process guides. Participates in inspection preparation activities and internal and external audits and audits CAPA… more
- Twist BioScience (South San Francisco, CA)
- Sr. Director , Manufacturing Execution System (MES) (Hybrid in South San Francisco)Job DescriptionWe are seeking an experienced and highly motivated Manufacturing ... Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, in-house developed MES solutions across our… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is capable of leading DM activities to support regulatory submissions and inspections . Finally, this position has advanced skills in continuous improvement, project ... timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection readiness of all data management activities conducted internally or… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for the global regulatory ... to ensure effective achievement of regulatory/business objectives. The Executive Director will direct the development and submission of investigational drug… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …(liaison with PhRMA, USP, ICH, due diligence, regulatory authority inspections ). Additionally, this position has direct interaction with research laboratory ... members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some complexity. This position makes decisions with consultation. Responsibilities:Planning for Development :… more
- Repligen (Hopkinton, IA)
- …work 1st shift. The QC Inspector I will report directly to the QA/QC Director . This position is responsible to actively participate in the Repligen ISO 9001 Quality ... role is responsible for inspecting, auditing and reporting on in-process and final inspection of single use assembly parts at the Hopkinton, MA production facility,… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... assembly equipment integrated processes such as ultrasonic welding and vision inspection systems.Author technical content of assembly process FMEAs to capture… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... principles. Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA).-Current Employees apply… more
- City of High Point, NC (High Point, NC)
- …Tuition Reimbursement Plan YOUR PURPOSE The City of High Point is seeking an Inspection Services Director to play a pivotal leadership role overseeing all ... and approval of construction plans submitted by public and private entities. Coordinates inspection staff to ensure timely inspections for both public and… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description General/Position Summary The Director , CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the ... and assures action execution to closure. Develops and implements strategies for inspection readiness, including mock inspections , training, and site preparation… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …operational execution. Relationships This position reports to the Sr Director , Patient and Consumer Insights. Other key relationships include interactions ... Operations Prepare reports and other documentation to assist with audits and inspections , both internal and by regulatory authorities Design, develop and manage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Good Practices Guides, and RBA/CSA methodologies to ensure compliance and inspection readiness.Stay current with emerging technologies and industry trends; lead ... of proven leadership experience managing technical and validation teams, preferably at Director or Senior Management level - Required 7+ years of strong expertise… more
- Clinical Dynamix, Inc. (Waltham, MA)
- …a collaborative team culture. *Assist with site/sponsor audits and regulatory inspections , assisting with in-house and site inspection readiness planning ... for a Contractor to be in place asap)! Reporting to the Sr. Director , Clinical Excellence Operations the Senior Manager/Associate Director , Records Management… more
- Total Action for Progress (TAP) (Roanoke, VA)
- …Operations Manger Participates in weekly/monthly production scheduling as directed by the Director of ECHR Perform Quality Control Inspection of completed jobs ... professional work in conducting energy audits and quality control inspections and performing duties as the Crew Leader when...standards and refer to the Weatherization Crew Chief and Co- Director . Complete a variety of assignments in the TAP's… more
- Monarch Healthcare Management (Minneapolis, MN)
- …bonuses Career path to other positions within our growing company! Social Services Director POSITION SUMMARY The Social Service Director is responsible for ... and procedures, and as directed by the Administrator. The Social Services Director interacts with the residents, families, visitors, other facility staff, and… more
