Lead the development and deployment of performance dashboards and analytic frameworks that support enterprise visibility, regulatory compliance and readiness, and strategic planning. Collect, analyze, and implement business requirements and...
with FDBT policies and practices. Ability to serve as deputy for Senior Director Quality Systems. Any other duties as assigned...Position Overview: The Director Quality Systems is responsible for developing, implementing, and maintaining...
with FDBT policies and practices. Ability to serve as deputy for Senior Director Quality Systems. Any other duties as assigned...Position Overview The Director Quality Systems is responsible for developing, implementing, and maintaining...
, increased productivity, and variability reduction. Responsibilities: The Senior Director, Quality Assurance, serves as the.... The senior director leads and/or participates in the assessment, development, and implementation of critical projects...
The Senior Director of Quality will lead and evolve the quality systems and processes across Ascend Wellness Holdings... in inspections and audits conducted by regulatory bodies. Be the voice of the customer within AWH: Keeping the customer at the...
Position: Senior Director/Executive Director, Clinical Quality Assurance (EDG-2025052) Location: Boulder, CO Job Id...: 207 # of Openings: 1 Senior Director/Executive Director, Clinical Quality Assurance About Edgewise Therapeutics...
, defining compliance KPIs, and implementing Corrective and Preventive Actions (CAPA)- related to audits and inspections findings... Safety Information (RSI) end-to-end process in QMS and other business guidance documents. As needed, scope...
regulatory inspections and corporate audits. Ensures inspection readiness, reviews QMS records, and drives timely completion... Quality Plan, and drives continuous improvement initiatives. Manage Audits and Inspections: Prepares for and manages...
, change control, and periodic reviews. Support internal and external audits, regulatory inspections, and RFI responses...Labcorp is hiring an Executive Director, IT Quality and Compliance. This is a strategic leadership role responsible...
, serve as the Subject Matter Expert (SME) to support inspections/audits by third parties (e.g., regulatory agencies), and the.... Job Summary: The Director of Validation will lead all validation activities across pharmaceutical and medical device...
responsibility for the quality of shipping product 5+ years in senior quality leadership roles (Director/VP level) Proven...) Good Manufacturing Practices Demonstrated experience with regulatory audits and inspections Strong background in CAPA...
audits and inspections Strong background in CAPA systems, risk management (ISO 14971), and design controls Experience...InnoTECH Staffing is looking to hire a Director of Manufacturing Quality for a medical device company in the Manchester...
, including responsibility for the quality of shipping product 5+ years in senior quality leadership roles (Director/VP level... Part 820) Good Manufacturing Practices Demonstrated experience with regulatory audits and inspections Strong background...
involves deputizing for the Sr. Director, representing the Quality organization at senior levels. The Director plays a pivotal... role in regulatory inspections, external audits, and high impact projects, fostering s culture of excellence and compliance...
Collaborate with Quality and Compliance teams to ensure readiness for regulatory audits and inspections Oversee governance, risk... In-depth knowledge of pharmaceutical regulations (GxP, GMP, GLP, 21 CFR Part 11) and experience supporting audits/inspections...
& development, custom formulization, graphic design, manufacturing, packaging and delivery. Senior Director Quality Assurance..., Quality Systems Management (QSM), and Compliance experience in highly regulated sectors. The Senior Director of Quality...
within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities... and compliance activities, including authoring and reviewing SOPs, facilitating internal audits, supporting regulatory inspections...
The role is responsible for supporting the Senior Director of Pharmacovigilance (PV) Operations with elements of the.... Participate in regulatory inspections and company audits including FDA/MHRA/EMA PV inspections. Prepare responses to audit...
inspections and audits - preparation, conduct and close out and response generation Key Capabilities: Understanding of SOP... improvement of Amgen’s R&D Quality Management System (QMS) and Regional Quality Oversight. Accountabilities: Assist...
in regulatory inspections and customer audits. Collaborate with the Director of Quality to address any findings or deficiencies... members. Occasional travel may be required for inspections, audits, leadership meetings, or training. Our Benefits (there...