- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …local and global markets. Liaises with regulatory agencies as needed and internally on GMP QA issues.Leads Global GMP Compliance team's participation in ... is a global role that is responsible for QA GMP activities pertinent to the overall compliance ...inspection readiness activities, including the execution of mock inspections , on-site inspection support during regulatory … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … inspection management activities by ensuring readiness, compliance , and inspection preparedness for the respective PV inspections in alignment with ... research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA,… more
- Merck & Co. (Durham, NC)
- …drug products, including biotech culture growth, harvest, lyophilization, product inspection , utilities, and warehouse.--As the team finishes the design and ... State and Local code requirements for quality, good manufacturing practices ( GMP ), equal employment opportunity, finances, labor, employee, environment, and safety,… more
- Aequor (Thousand Oaks, CA)
- …chromatography, and data analytics and visualization knowledge. Job Summary: The Product Quality Director is the champion for a product team as the Product Quality ... standards, importation testing, investigations, change control, regulatory submissions and inspections . The PQL has responsibility for driving change to implement… more
- Careerbuilder-US (El Segundo, CA)
- …Disposition. This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements. This position ... El Segundo, CA site and report into the Associate Director of Quality Operations. NOTE: Position is Day Shift...at multi-site disposition meetings * Support and participate in inspections and audits Basic Qualifications: . Master's Degree and… more
- 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
- ThermoFisher Scientific (Waltham, MA)
- …ISO or ICH, and hosting/supporting FDA, EMA, MHRA, AIFA, ANVISA and/or other regulatory inspections . + Must be an expert Quality compliance auditor. + Experience ... **Job Description** We are looking for a highly skilled pharma- GMP auditor and risk management leader. This leader will...**What will you do?** We identify systemic gaps in quality/ compliance by conducting internal audits of Thermo Fisher Pharma… more
- Charles River Laboratories (Boston, MA)
- …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
- Amicus Therapeutics (Princeton, NJ)
- …temperature excursions, product complaints in compliance with the requirements of GMP . * Ensures Inspection Readiness and supports Amicus and our External ... Associate Director , External Quality Lead (Small Molecule) Location Princeton,...actively engaged in ensuring outsourced manufacturing is performed in compliance with Amicus procedures and standards, and applicable regulations… more
- Olympus Corporation of the Americas (San Jose, CA)
- …Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and ... inspections and audits and ensures successful outcomes through inspection readiness activities, inspection management and observations resolution. +… more
- University of Rochester (Rochester, NY)
- …GCPs, GLPs, and other regulatory agencies (eg OSHA), including the need to serve as on-site director in compliance with 21 CFR Part 210 & 211. + Responsible to ... of international regulatory standards as necessary to maintain internal and regulatory compliance . Participate in external and internal inspections from client… more
- Rhythm Pharmaceuticals (Boston, MA)
- …validated electronic system that houses all of Rhythm's GxP records. The Associate Director QA will lead the Quality and Compliance governance and ensures ... for continuous improvement and maintain a steadfast growth in Rhythm's quality culture and compliance stance. The Associate Director QA will report to the Head… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …agencies. + Function as the CMC QA subject matter expert during regulation inspections . + Participate in the site inspection readiness program. + Support ... real-world evidence, and creating hope for all facing illness. As a Senior Director of Quality Assurance CMC, you will be responsible for providing operational… more
- Organon & Co. (Plymouth Meeting, PA)
- …technical advice, counseling to site leadership, and on-site supervision. The Associate Director may serve as a subject matter expert for External Quality Assurance ... Behaviors and provides a leadership example for the team. + Assures compliance with established policies/procedures of the Division and Corporation and complies with… more
- Bristol Myers Squibb (Devens, MA)
- …function; at minimum 7 years of people management experience.** + **Expertise in GMP compliance and FDA/EMA regulations.** + **Develop and continuously improve ... personal lives. Read more: careers.bms.com/working-with-us . **Position Summary:** **The Director , Quality Disposition Operations will be responsible for the… more
- Lilly (Lebanon, IN)
- …enhances organizational capabilities and ensures personnel qualification. The Associate Director is responsible for enhancing employees' capabilities to meet site ... training meet corporate and site quality standards. Additionally, the Associate Director will oversee performance consulting for business partners to assess critical… more
- Lilly (Lebanon, IN)
- …GMP manufacturing operations._ **Position Brand Description:** The Associate Director Manufacturing Operations is directly responsible for managing the day-to-day ... and continuous improvement in pursuit of Operational Excellence. The Associate Director Manufacturing Operations provides leadership, acts as a key integrator, has… 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
- ThermoFisher Scientific (St. Louis, MO)
- …St. Louis site as a domain expert during external and internal regulatory compliance inspections . + Support the authoring, reviewing and approving of regulatory ... will you make an impact?** The Manufacturing Sciences and Technology (MSAT) Director is responsible for leading all facets of Process Validation, Technology Transfer… more
- Gilead Sciences, Inc. (Foster City, CA)
- …Join Gilead and help create possible, together. **Job Description** **Senior Director , Purification Process Development - Pivotal & Commercial Biologics** The Senior ... Director of Purification Process Development for Pivotal and Commercial...transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on… more
