- Takeda Pharmaceuticals (Cambridge, MA)
- …application is true to the best of my knowledge. **Job Description** **R0131761** ** Senior Internal Auditor ** **Takeda Pharmaceutical** **USA - MA - Cambridge - ... - 500** **About the role:** Join Takeda as a Senior InternalAuditor, where you will Conduct audits of Takeda's...and regulatory requirements defined by Federal healthcare aws, OIG compliance program guidance, FDA legislation, FCPA, UK… more
- Verista (Las Vegas, NV)
- …learn from our experiences to enhance our collective expertise Principal Quality/GxP Auditor Responsibilities: + Develop and present Compliance plans and ... subject matter expert in all areas of Quality & Compliance . + Guide and ensure client compliance ...level requirements. + Demonstrated capability to deliver on the Senior Quality Lead Responsibilities. + Demonstrated expert knowledge of… more
- ThermoFisher Scientific (Middleton, WI)
- …Impactful Work:** Conducts internal and/or external audits to ensure compliance with established quality assurance processes, standards, global regulatory guidelines ... GxP audits and supports regulator inspections as requested by senior management + Participates in process audits + Performs...to perform GxP audits based on SOPs and applicable FDA regulations, ICH guidelines and to all other standards… more
- Cardinal Health (Columbus, OH)
- …visibility into risk and control landscape. + Prior experience with key IT regulation compliance including HIPAA, FDA , DEA, PCI, DFARS/CMMC, SOX, etc. + Prior ... will play a Lead role focused on identifying key IT controls and compliance requirements and confirming that controls are being designed and implemented as solutions… more
- Eurofins (Centennial, CO)
- …of quality and access to innovation across all the regions we serve. Senior Regulatory Affairs Specialist responsibilities include, but are not limited to, the ... Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT's laboratories are compliant… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- **Job Description Summary** The Senior Quality Engineer has responsibility for applying/interpreting the applicable Quality Systems, developing/implementing the ... May support both internal and external audits by assuming the Lead Auditor role. Responsibilities include monitoring and trending quality indicators for purchased… more
- United Therapeutics (Silver Spring, MD)
- …+ Analyze variances and annual trends to determine explanations for internal reporting to senior management and for external auditor support + Support SEC filing ... and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials,… more
- Medtronic (Grand Rapids, MI)
- …Manufacturing sites in Grand Rapids, MI where we are seeking a hands-on ** Senior Supplier Quality Engineer** **.** This site supplies Medtronic with some 600 ... highest quality and reliable products. + Provide technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly… more
- LSI Solutions (Victor, NY)
- …to Domestic Regulatory Projects will 1) prepare regulatory submissions, including FDA Q-Submissions, 513(g) Submissions, 510(k) Submissions, and De Novo Requests as ... 5) read and interpret regulations for new and current compliance procedures and regulatory enforcement trends/actions; 6) participate in...Specialist role has four levels: I, II, III, and Senior . All Regulatory Specialists I, II, III, and … more
- Nestle (Waltham, MA)
- …unique opportunity to apply GMP principles to an area as yet unregulated by the FDA . Our unique product provides the opportunity to grow within a cutting edge GMP ... projects and programs, ensuring follow up activities are completed and in compliance with requirements. * Perform detailed batch record reviews and participate in… more
- LSI Solutions (Victor, NY)
- …The Quality Assurance Manager is responsible for ensuring full standards compliance , leading LSI's CAPA function, implementing internal audit programs to ensure ... QMS compliance and efficiency, and providing vision, guidance, and validated...is organized; how its components map to ISO 13485, FDA QMSR, EU MDR, and MDSAP requirements; how the… more
- Eurofins (Centennial, CO)
- …Manager, Regulatory Affairs and Quality Assurance, this position in tandem with Senior Management, will assist with ensuring that DPT's laboratories are compliant ... and contributes to providing internal advice on regulatory and accrediting compliance . + Anticipates regulatory obstacles and emerging issues related to laboratory… more
- Catalent Pharma Solutions (Harmans, MD)
- …live better, healthier lives. Catalent's Harmans/BWI, MD facility is a FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus ... features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites,… more
- Takeda Pharmaceuticals (Boston, MA)
- …initiatives and special projects * Manage up to one direct report, such as an Auditor or Senior Auditor , supporting career development and delivery of ... risks and regulatory requirements defined by the federal Anti-Kickback Statute, OIG Compliance Program Guidance, FDA legislation, FCPA, UK Bribery Act, etc.,… more
- Catalent Pharma Solutions (Harmans, MD)
- …live better, healthier lives. Catalent's Harmans/BWI, MD facility is a FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus ... features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites,… more
- Flexan (Salt Lake City, UT)
- …and processes across the site. This position oversees quality assurance and compliance functions and ensures integration throughout departments to ensure the Quality ... + Oversees the management of the QMS to ensure compliance with relevant regulatory bodies. + Accomplishes quality assurance...able to present quality data to their customers and senior leadership in a concise, effective manner. + Demonstrates… more
- BlueTriton Brands (Charlotte, NC)
- …**Job Description** **The Corporate Quality Supervisor will report into the Senior Manager, Corporate Quality** and is responsible for providing executional ... supervise quality performance and Key Performance Indicators (KPI) to assure compliance to corporate quality policies and procedures, and regulatory requirements.… more
- Integra LifeSciences (Princeton, NJ)
- …include working with Integra manufacturing sites and suppliers in support of compliance requirements for human and animal tissue products. Qualified candidates must ... and its application in medical devices. The candidate must be a senior -level professional/team player with advanced knowledge and experience who thrives in a… more
- Sanofi Group (Morristown, NJ)
- …Healthcare or Pharma industry preferred + Strong knowledge in GMP Regulatory Compliance , including Regulatory audits + Certified Quality Auditor preferred + ... the Job_** If you're driven by a commitment to excellence, adept at regulatory compliance , and skilled in leading teams to ensure the safety and efficacy of our… more
- University of Rochester (Rochester, NY)
- …and non-departmental personnel to assure that this institution is in compliance with study guidelines as detailed on the individual treatment protocols. ... Ensure timely submission of this study data. Regulatory + Ensures compliance with acceptable regulatory requirements and IRB standards. The regulatory agencies… more