What Does A Senior Quality Assurance Manager Do At Hologic
* Establishes requirements for and manages the root cause investigation program.* Establishes, maintains and manages the CAPA program.* Establishes, maintains, and manages the audit team and program (internal, third-party and supplier)* Facilitates and manages the material review board (MRB).* Facilitates and manages the Product Quality Committee (PQC).* Establishes, maintains and facilitates the CAPA review board.* Provides site training on root cause investigations, audits, CAPA, and other applicable quality systems as well as the tool that manages these processes (Agile).* Interacts with and leads teams made up of other site leaders to improve the Agile system and shared processes.* Continuously works on projects to increase efficiency of quality processes.* Prepare for and lead in third party regulatory and supplier audits and inspections.* Ensures compliance to site, corporate, and regulatory requirements as defined by applicable regulatory bodies and agencies. * Accurately and effectively translates applicable requirements into workable systems and procedures.* Ensures that related Quality System processes are established and maintained.* Promotes awareness of regulatory and customer requirements.* Supports the ongoing development and implementation of a Corporate Quality System.* Sets departmental goals and objectives that are aligned with divisional goal and ensures they are met.* Ensures development, maintenance & reporting of related department metrics.* Supports the collection and reporting of Corporate and site KPI data in support of Management Reviews.* Writes investigation and trend analysis reports.* Other duties as assigned
What Does A Senior Quality Assurance Manager Do At Thermo Fisher Scientific
* Provide quality system leadership to assure internal policies, customer expectations, and regulatory requirements are met* Lead the Quality Management System for an ISO 13485 plant registered with the FDA as a medical device manufacturer of Class 1 and Class 2 Devices (21 CFR part 820)* Closely partner with key pharmaceutical customers to adopt the management system and manufacturing methods to meet aseptic manufacturing standards and applicable 21 CFR part 210/211 and EU requirements* Manage the site Quality Management System including assuring effective management reviews, complaint handling, CAPA system, change control, calibrations maintenance, validation, internal auditing, training, R&D transfers, and manufacturing area support* Actively manage the Quality Control team performance to meet standard turnaround times.* QC test first pass yield (test/retest error), and labor efficiency* Closely partner with the Global Design Quality Assurance organization to drive robust design transfer and long term new product introduction success* Set site wide QA/QC priorities and key objectives to reduce the cost of poor quality and improve the compliance to regulations and the site Quality System.* Ensure site wide training is effective and that the plant operates within the required regulatory guidelines by examining and testing plant-wide processes and products from a final product acceptance and compliance perspective* Provide significant knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks.* Drive a culture of continuous improvement by employing Practical Process Improvement concepts* Manage the metrics and tier system escalations and reporting
What Does A Senior Quality Assurance Manager Do At Gilead
* We are seeking a Quality Assurance* professional, ideally with experience in commercial parenteral manufacturing* operations with an in-depth knowledge of global regulatory and compliance* requirements.* The role is responsible for the administration of quality* standards and practices within a multi-national organization, with direct* quality management oversight of global third party contract manufacturers.* This* Quality professional will be a strategic leader in a cross-functional* management team.* Responsibilities include
What Does A Senior Quality Assurance Manager Do At Abbvie
* bull; Independently manages review and approval of master batch records, labels, specifications, and other manufacturing documents of clinical and commercial drug substances and drug products in compliance with all applicable requirements.* bull; Independently manages review and approval of executed manufacturing records, analytical data, and associated documentation, including deviations and investigation reports related to production and disposition.* bull; Leads, trains others and approves Quality investigations.* bull; Leads the review and approval of change control requests to ensure compliance with all applicable requirements.* bull; Lead QA representative, including compliance responsibility, on the internal CMC team.* bull; Leads and trains others in internal audit and vendor management programs.* bull; Prepares and presents quality metrics.* bull; Independently initiates and approves SOP updates and creation of new SOPs.* Additionally, oversees review of SOPs and associated documentation to ensure biennial review requirements are met.* bull; Lead Quality representatives for regulatory inspections.* bull; Lead establishment of Quality-specific documents (e.g., Quality Risk Management Plan, Quality Agreements, Site Master File, and Validation Master Plan).* bull; Ensure Quality processes at PCYC and across the supply chain comply with all applicable regulations and guidelines.* bull; If this position has direct reports:* o Provide technical guidance and timely performance feedback through routine 1:1 meetings.* o Provide technical development through OTJ training.* o Work with HR to ensure opportunities for professional development.* o Assist with developing individual goals and objectives
What Does A Senior Quality Assurance Manager Do At Lg Electronics USA, Inc.
* Be hands on and fully capable of doing the job of your quality engineers will do on a daily basis.* Hire and maintain a team of quality engineers both locally in Silicon Valley and in various other global sites.* Coach and inspire the members and extended members of your team.* Partner with various cross functional teams identify the work your team can commit too.* Manage the backlog for your team; it needs to be clear and well prioritized.* Identify and communicate schedule risks early in the project.* Define and track metrics to raise attention to the quality issues your team is identifying in a way that the engineering team will pay attention too and take appropriate actions.* Represent the impact of your team in various progress reporting meetings (i.e. sprint reviews, scrum of scrums, etc.).* Define new testing processes to streamline your team’s efficiency.* Design and implement automated testing scripts.* Identify product defects early and communicate the deficiencies clearly.* Define, monitor and achieve exit criteria quality gates
