- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure departmental KPIs and regulatory compliance are consistently met Implement Medical Review Prospective & Retrospective Quality Review of cases ... find better and more innovative ways to improve their quality of life. We're changing lives for a living.... Board as required. Essential Functions Leadership & Oversight Lead and manage the Medical Review Case… more
- Jazz Pharmaceuticals (Redwood City, CA)
- …responsible for the execution of issue management processes, assisting and/or leading audit and inspection processes and preparing for governance meetings to achieve ... Advise on deviations and change control management process. Partner with Quality , Regulatory Affairs, Regulatory Operations and CMC and Labeling organizations in… more
- Insmed Incorporated (NJ)
- …through Phase 3, ensuring compliance with GMPs and internal standards.Serve as the Quality lead for GMP activities supporting clinical trial materials, including ... Establish QA-QA relationships and checkpoints for critical CDMOs and service providers. Lead or support Quality Agreements, risk assessments, audits, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …implementation of obligations deriving from these contracts. Organize and conduct periodic review of contract quality and adherence PV Regulatory Intelligence: ... and dissemination across CSPV stakeholders for impact assessment. Participates in the review and management of monthly, quarterly, and ad hoc PVRI reports received… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …business functions in a timely manner through appropriate forums, such as Quarterly Quality Reports (QQRs) and Quality Review Boards (QRBs).Collaborate with ... Health Authority inspections and approvals - Proactively partner and lead the strategic collaboration with other GxP Quality...quality reviews of product profiles, ensuring thorough management review of all quality and compliance topics,… more
- Cipla (Central Islip, NY)
- …new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect. Review of laboratory audit trials during data review against ... 8:30AM - 5:00PM (may vary based on business needs) Reports To: Quality Assurance Manager Purpose: This position requires a strong analytical chemistry/lab background… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... Safety, with cross-functional working relationships within Intake and Triage, Medical Review , Submissions and Compliance, Global Safety, and centralized teams (eg,… more
- Cipla (Reid, WI)
- …to the company's document and SOP's procedures while ensuring their accuracy, quality , and integrity. This position reports to the Department Head - Manufacturing ... to the following : Works with Manufacturing/Packaging to deliver timely batch record review across all shifts. Reviews and approval of master batch records. Develops… more
- Cipla (Fall River, MA)
- …to cGMP and set standards to meet the regulatory requirement and to ensure audit readiness. Monitor material is stored as per proper storage condition with required ... ensure clearance of items before expiry to control the cost of inventory. Review the non-moving, low shelf life items periodically and ensure timely disposal.… more
- Allied Solutions LLC (Carmel, IN)
- The Quality Assurance Coordinator is a recognized leader who is responsible for the assessment of risks and quality in accordance with the mission and strategic ... goals of the organization. They conduct quality audits/reviews to assure service, accuracy, and adherence to...sizes, and population subsets to determine the employees requiring audit activity and results for the month. Perform Employee… more
- Salamander Solutions (Houston, TX)
- …import/export regulations. Conduct regular audits to maintain ISO compliance and drive quality improvements. Lead internal audits and support external audits by ... Collaborate cross-functionally with Engineering, Operations, and Supply Chain to align quality systems with business goals. Coordinate creation, review , and… more
- Plante Moran (Denver, CO)
- …Join us. Your role. Your work will include, but not be limited to: Lead and supervise the staff consultants, ensuring timely and effective issue resolution. Serve as ... Oversee technical service delivery to clients, ensuring SLAs are met and high- quality support is consistently provided. Collaborate with internal Managed IT team… more
- Resurgence Veterinary Mobility (Decatur, GA)
- …Management Software (PMS) to schedule, adjust, monitor, and confirm appointments. Audit daily patient schedules, remove blocks, and address incorrectly scheduled ... collected. Address client concerns and grievances and escalate to lead CSR, leadership, or a DVM when necessary. Finance...Reconcile all transactions at the end of the day. Audit transactions daily and weekly. Troubleshoot discrepancies. Know all… more
- Plante Moran (Southfield, MI)
- …Join us. Your role. Your work will include, but not be limited to: Lead Operations engagements for clients in a variety of industries (Manufacturing & Distribution; ... by driving growth and new client opportunities through client expansion and lead generation Lead practice building and development activities, including… more
- Sandoz Group AG (Princeton, NJ)
- …and adherence to CIA obligations, CIA-related deliverables, and any relevant audit , monitoring or Independent Review Organization (IRO) remediation. Sandoz ... Generics Institutional, Hospitals and Clinics business (IHC Gx), you will lead our commercial efforts across multiple pharmaceutical products and therapeutic areas.… more
- Slate Auto (Troy, MI)
- …to ensure alignment with evolving regulatory requirements and industry best practices. Lead the preparation, review , and submission of external and internal ... recommendations. In addition, you will participate in the preparation and review of external financial statement disclosures, ensuring they are complete, accurate,… more
- Plante Moran (Chicago, IL)
- …and governance Engage in training and self-study to further your career development Lead training of staff on the job and in internally developed training activities ... IT certifications are preferred; CISA, CPA, CISSP, CRISC, CCSFP, ISO 27001 Lead Auditor Supervising staff and providing written and verbal performance feedback… more
- Plante Moran (Denver, CO)
- …Manager/Senior Manager will play a crucial role in supporting a culture of quality and operational excellence within the tax department. This position involves the ... tax regulations and alignment with current tax business goals. Responsibilities: Lead efforts in documenting and standardizing processes, including identifying and… more
- Sandoz Group AG (Denver, CO)
- …and adherence to CIA obligations, CIA-related deliverables, and any relevant audit , monitoring or Independent Review Organization (IRO) remediation. Sandoz ... be responsible for responsibilities like the below but not limited to: Lead the development and implementation of detailed business plans, with appropriate… more
- Airlite Plastics (Lakeville, MN)
- …solutions, we strive to provide our customers with top-notch service and quality , which aligns with our award-winning products. How would you contribute? This ... store raw material and finished goods. Manages and qualifies new vendors. Performs audit on vendors. Manages on time delivery of products from vendors. Improve… more
