Director Quality and Quality Management Systems

Profile

If you want to be a part of a team that is passionate and dedicated to saving lives threatened by the global public health crisis of infections, then this top tier company might be the right place for you. We strive to offer a dynamic work environment in which innovation, teamwork, knowledge, and flexibility are valued.
The company's novel antibiotics portfolio has the unique ability to offer providers and patients a range of solutions that can meet the tremendous need for treating serious infections. We encourage the appropriate use of our products at various call points within the hospital or account ecosystem, including clinicians, Long Term Care Hospitals and various types of infusion centers. While antibiotics will remain a central component of our focus, we also plan to augment our novel and important portfolio with products that address critical needs in other acute therapeutic areas. Visit (link removed) for more information.
Job Summary
The Director, Quality (with an emphasis on QMS) is responsible for managing the Quality System as well as Quality continuous improvement efforts across the organization. This position reports directly to the Vice President, Manufacturing, Supply & Quality.
Duties and responsibilities
Promotes the quality culture throughout the organization
Responsible for the maintenance and management of the Quality Management System including
Document Control, CAPAs, Quality Events, Change Controls, Complaints and Q10 to assure quality of Company products
Develop fit-for-purpose internal SOPs, work instructions, and other processes to ensure appropriate employee training and adherence to quality management system (QMS) across the GxPs
Responsible for planning and budgeting pertaining to Quality activities.
Manage GxP inspections and audits from both regulatory authorities and marketing partners and provide follow-up responses for all aspects of the business
Manage corporate training for GxP training and collaborate cross-functionally in regard to non-GxP training
Manage and own the administration of the Quality electronic systems, including vendor management, and business owner of Trackwise, Redica and WGC AVOCA Quality Consortium
Oversee Product Complaints for commercial and clinical trial materials
Support activities for company's Global License Partners in relation to the quality systems.
Provide direction and strategy to identify, assess, and remediate current and previous quality system risks, gaps, including conducting corporate gap assessments and development of standards
Partner with various key stakeholders across the organization to assess all quality systems and standards needs and to provide resource and support for planning and execution
Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification. Such duties may include opportunities for growth and development.
Qualifications
Must have experience with TrackWise QMS and at least 7 years experience in Quality in a pharmaceutical company
Experience supporting commercial, manufacturing and research and development functions
Experience managing quality management and continuous process improvement principles including global cGMP requirements, ISO 13485, ICH Q8, Q9, and Q10, and other relevant regulations and guidance to assure quality of Company products
Good written and oral communication skills
Ability to prioritize and multitask necessary
Demonstrated ability to work in a multi-disciplinary setting
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