- Regeneron Pharmaceuticals (Rensselaer, NY)
- We are currently looking to fill a Director of GMP Compliance & Inspections position. This position will work with cross-functional teams to drive ... will ensure a state of continuous GMP compliance in Regeneron IOPS and to build inspection...we are performing with in compliance . The Director will also provide support during regulatory inspections… more
- Lilly (Indianapolis, IN)
- …quality oversight of Indianapolis Parenteral Manufacturing's central quality processes. The Associate Director for Site Quality & Compliance is responsible for ... for complaint investigation management and oversight of the IPM GMP Library within the Site Quality & Compliance...quality medicine, strong quality culture and maintenance of cGMP compliance and inspection readiness + Actively participate… more
- Novo Nordisk (Clayton, NC)
- …interest in ensuring high quality raw materials for Novo Nordisk US. Relationships Director , US Sourcing Hub. Essential Functions + Responsible for raw materials & ... based on the use at Novo Nordisk to ensure compliance & patient safety + Participation in approval of...organizations + Prepare proper documentation of activities to ensure inspection readiness + Other accountabilities, as may be assigned… more
- Takeda Pharmaceuticals (Boston, MA)
- …operational and compliance metrics and storyboards, identify quality and compliance inspection risks, and provide tactical directions in the mitigation. ... to the best of my knowledge. **Job Description** **Job Title** : Associate Director , Clinical Quality Compliance **Location** : Cambridge, MA **About the role:**… more
- Amicus Therapeutics (Marlow, OK)
- …and Quality Control activities within Amicus and External Partners. . Facilitate or host GMP inspections by regulatory authorities and maintain a state of ... for leading Amicus' Quality Operations Team, ensuring a robust GMP Quality System and compliance of our...PMDA, and other global regulatory agencies. Ensure readiness for inspections of both internal and external GMP … more
- Lilly (Pleasant Prairie, WI)
- …place and maintained. He/she leads and responds to regulatory agency inspections and inquiries. He/she reviews/approves GMP documentation including procedures, ... to increase the value of Lilly products. The Senior Director , Quality Assurance, is primarily responsible for overseeing the...and lead the Quality Lead Team. + Ensure overall compliance with GMP regulations, Lilly Corporate Quality… more
- Merck (West Point, PA)
- **Job Description** The Associate Director , Technical Operations, is responsible for the management and oversight of a team providing technical support for a live ... team and installation of robust CAPAs, among other related duties. The Associate Director will have overall responsibility for the performance and results of the… more
- Gilead Sciences, Inc. (Foster City, CA)
- …together. **Job Description** We are currently seeking an industry leader for a Director , Quality Assurance role, who will report to Executive Director , Supplier ... Quality Management and Audits, within the Global Quality Systems & Compliance department. The role is highly visible, offer tremendous growth potential, and requires… more
- Bristol Myers Squibb (Libertyville, IL)
- …functions, and a minimum of 7 years of people management experience + Expertise in GMP compliance and global (eg, US, EU, JP) regulations + Experience in hosting ... practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GMP ...compliance at the facility + Lead and host compliance audits and regulatory inspections by competent… more
- Charles River Laboratories (CA)
- …that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance ** to join our **Insourcing ... San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance ** ,...up, of internal and external site visits, audits, and inspections eg, client audits, the IACUC, outside regulatory and… more
- Kelly Services (Dallas, TX)
- Director of Quality Management- Dallas, TX The Director of Quality Management is responsible for the overall performance of the quality assurance and quality ... System by overseeing key processes and activities such as the inspection process, nonconforming materials process, internal and external audits, Corrective and… more
- Healgen Scientific Limited (Houston, TX)
- …/ Component release, Quality & Validation Engineering, Final Product Release and Site Compliance & Inspection Readiness. The role is responsible for developing ... is expected to host both internal and external regulatory inspections supported by the Global Compliance organization....that the site is in a continued state of compliance and inspection readiness including analysis and… more
- Astellas Pharma (Westborough, MA)
- …long- term objectives for the QA organization to fulfill the regulatory requirements for GMP and compliance for CTM and commercial products. + Ensures alignment ... **Quality Assurance, Site Leader (Senior Director )** Do you want to be part of...is accountable for the execution of all aspects of GMP or non- GMP QA activities. This position… more
- ALDI (Batavia, IL)
- …of private label products, is seeking a dynamic leader to fill the role of Director of Food Safety and Quality Assurance. This is your chance to spearhead the ... quality strategies that will shape the future of our organization. As the Director , you'll have the opportunity to drive innovation, maintain rigorous standards, and… more
- Lilly (Durham, NC)
- …make life better for people around the world. Overview: Quality Control Associate Director (QC AD) is responsible for leading the QC organization for the ... and support of the ongoing operation as well as site inspection readiness and execution. Responsibilities: + Demonstrated technical competency (method understanding)… more
- Endo International (Rochester, MI)
- …development and new product/process/technical transfer activities associated with employee operations, GMP Compliance and safety.** **Lead initiatives for root ... individuals to join our team. **Job Description Summary** The Director of Operations at the Rochester MI facility leads...associated with Quality Management System (QMS), cGMP and EHS compliance . The individual must have the ability to coordinate… more
- Boehringer Ingelheim (Athens, GA)
- … and efficient QC processes.This position may serve as a deputy for the Director , Quality and Compliance in his/her absence. Responsible deputy during absence of ... Directs and provides technical oversight and Regulatory and GXP compliance for the purity, potency, safety and stability testing...auditing, and reviewing test methods, test records and other GMP + documentation, hosting inspections and audits… more
- ICU Medical (Salt Lake City, UT)
- …QSRs, MDD, MDR, ISO9001, ISO13485, etc.) is required . Experience with FDA inspections and successful track record with inspection outcomes . Demonstrated ... *Position Summary* The Director , Quality plays a vital role by overseeing...Making: Handles customer issues and provides oversight for cGMP compliance in investigations and device service activities. . Customer… more
- Lilly (Durham, NC)
- …are determined to make life better for people around the world. Associate Director - Quality Assurance (QA) Packaging is responsible for the staffing, training, and ... Packaging (DAP) production area at Lilly RTP. The Associate Director will help build a strong quality culture and...support of the ongoing operation as well as site inspection readiness and execution. Responsibilities: + Supporting the site… more
- BeiGene (San Mateo, CA)
- …controlled way that is in accordance with regulatory expectations and applicable GMP /GDP quality standards. The role has global responsibility and accountability for ... CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed. +...commercial supply eg timely batch release + Support GCP inspections in IMP manufacturing perspective + Execute product recalls… more