What Does An Associate Director, Quality Assurance Do At Abbvie
* Manage the validation system froma Quality Assurance perspective to ensure quality and compliance requirementsare met in an efficient and effective manner, and in support of corporateobjectives* Provide guidance onqualification/validation issues.* Act as the validation SME forEquipment Change Controls supporting GMP/GLP systems.* Ensure required StandardOperating Procedures and systems are implemented to support internal andexternal validation programs for antibody intermediates, small moleculeintermediates, antibody-drug conjugate drug substances and drug products.* Quality oversight andapproval of software, equipment/facility qualification, IQ/OQ/PQ protocols andreports and associated change control systems.* Ownership of the Site ValidationMaster Plan.* Quality oversight andapproval of internal and external method qualification, method transfer andmethod validation project plans, protocols and reports.* Quality oversight andapproval of internal and external process characterization project plans,protocols and report.* Report validation/qualificationquality issues and trends to management
What Does An Associate Director, Quality Assurance Do At Cerus Corporation
* Oversee assigned quality assurance activities related to FDA regulations and ISO standards for medical devices, pharmaceuticals, and biologics.* Perform supplier quality audits and facilitate corrective actions.* Interact with suppliers on quality matters.* Review/approve validation protocols and reports Conduct internal audits/inspections of regulated in-house operations.* Host/support inspections of facilities and contract organizations by national and international regulatory agencies and notified bodies.* Identify, organize and adapt implementation of new state/local/federal/international regulations and standards.* Identify compliance weaknesses and ensure the implementation of workable solutions.* Audit study reports and raw data for compliance with protocols, SOPs and regulations.* Audit manufacturing and QC records/documentation.* Regularly interact with Cerus management regarding quality matters and communicate compliance requirements at all levels.* Provide training and guidance in the areas of government regulations to effected employees.* Proactively communicate concerns and/or risks to manager or Sr.* Management when appropriate.* Establish and maintain collaborative relationships with cross-functional teams.* May supervise or provide guidance to lower level staff
What Does An Associate Director, Quality Assurance Do At Sutro Biopharma, Inc.
* This individual will be responsible for supporting cGMP operations in Sutro Biopharma---s cGMP
Manufacturing Facility and will, at a minimum, include:
Hire, Develop, Motivate and Lead the Quality Assurance group.
Implement QA strategies in support of cGMP manufacturing at San Carlos Mfg. facility.
Lead the development, implementation, and maintenance of Sutro quality management systems and activities.
Act as management level QA liaison with Manufacturing, Quality Control and other appropriate organizations
Perform reviews of cGMP documentation, both at Sutro and contract organizations.
Review and approve completed batch documentation for cGMP production, including QC documentation of release and in-process testing.
Lead investigation and resolution of cGMP or procedural compliance failures, as well as work with staff from other departments to resolve compliance issues found during the Quality review.
Release raw materials and batches/lots for further manufacturing, clinical trials and commercial distribution.
Conduct supplier evaluations to assure potential and/or current vendors and contract organizations are acceptable for use by Sutro.
Perform Quality audits of potential and/or current vendors and contract organizations, as well as internal departments.
Oversee and perform training of personnel to ensure compliance and conformance to Sutro---s requirements.
Manage and perform day-to-day activities of the Document Control, including creation and/or revision, processing, routing and releasing controlled documents.
This individual will be expected to effectively follow Sutro Biopharma---s SOPs and policies, and cGMP compliance regulations.* Additionally, he/she should be able to independently manage review times to meet Sutro---s priorities and communicated timelines.
This individual may be asked to travel on behalf of Sutro Biopharma to support business operations that involve contract manufacturing.* Anticipated travel is approximately 5*
What Does An Associate Director, Quality Assurance Do At Astellas Pharma
* Develops strategy and executes the direction for Clinical QA's approach under the guidance of the Sr.* Director/Director.* In collaboration with the CRQA Management Team and stakeholders regionally and globally, implements the development of this approach to ensure an effective audit program which complies with regulatory requirements and stakeholder expectations.* Provides the leadership to drive the development, communication, implementation, maintenance and execution of standards and processes within the function and communicates to relevant stakeholders.* Manages and directs the Clinical QA staff and/or provides leadership, development, mentoring and support for direct reports and/or appropriate Clinical QA resources.* Could be responsible and accountable for the Clinical QA staff recruitment, development and performance management and organizing CRQA teams for maximum effectiveness.* Continuously evaluates the strategic approach, drives changes in the audit program to meet changing needs of the organization, regulatory environment and industry best practices.* Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors)* Creates and implements the appropriate strategic risk-based support model for each project.* May represent Clinical QA as a Global Quality Lead (GQL) for critical, later stage development projects and Therapeutic Areas.* Develops staff to be able to adequately assume the role of GQL to represent Clinical QA on project teams.* Development of short and long-term risk-based quality strategies in support of M&D development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate.* Collaborates within CRQA and M&D functions to establish the global audit program.* Responsible for managing the assigned budget for the Clinical QA group as part of the overall CRQA budget.* Manages and grows the Clinical QA resources as appropriate through effective recruitment, performance management, development planning and retention.* Delegates responsibilities and empowers team members to achieve goals.* Provides optimal oversight and supervision while developing individuals and leveraging their skills and abilities to ensure goals are achieved.* Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CRQA key stakeholders and M&D functions, as well as of relevant external stakeholders.* Quantitative Dimensions:* Supports/manages up to 3 Clinical QA resources and/or directly manages 1* process improvement initiatives * Responsible for a budget up to $500K* Annual auditing of up to 50 audits globally* Functional Service Provider (FSP) governance support for up to 5 FSP relationships* Responsible for the development and execution of inspection readiness plans of approximately 1* annum for regulatory agency inspections related to MAA / NDA submissions* Responsible for supporting regulatory agency inspections of GCP activities and ensuring inspection readiness with an average of 4 inspections/annum.* Organizational Context:* This position: Reports to the Senior Director/Director, Clinical QA* Peers to this position include CRQA Team Leads, global and regional medical and development team leads and other functions such as finance, legal, etc.* Supports/Manages up to 3 direct reports and/or outsourced support staff excluding administrative assistants * Collaborates directly with M&D personnel
What Does An Associate Director, Quality Assurance Do At Quintilesims
* Provide guidance, interpretation, support, training, and key input to clinical development operational staff on interpretation of GCP regulations, guidelines, corporate standards, and policies. * Host customer audits and participate in review of corrective action plans. * Recommend systems for audit, write systems and procedures audit plans and coordinate scheduling, conduct, reporting and closure of internal systems and procedures audits. * Plan,schedule,conduct, report and close audits of clinical research activities in any of the countries involved with corporate contracts. * Serve as Global QA Contact for assigned customers and Quintiles functional areas. * Oversee documentation, reporting, and closure of compliance issues. * Support director in proposal reviews and reporting QA metrics. * Conduct trend analysis of audit results and provide QA management with initial root cause analysis * Ensure proper coordination of customer-initiated audits and mock regulatory inspections, and manage regulatory facility inspections. * Recommend staff management actions in accordance with organization’s policies and applicable laws.* Recommendations include training, coaching, and mentoring employees; planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems