Director Quality and Quality Management Systems

2 weeks ago

Parsippany, United States Clinical Dynamix Full time

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 www.melinta.com 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

Education

BS or BA in Life Sciences or Natural Sciences; advanced degree preferred

Position Type and Location

Full Time (In Office 3-4 days a week / Hybrid Schedule) Can be located close to Parsippany, NJ office or Chicago, IL office (Lincolnshire)

Travel

Travel as appropriate to implement strategic initiatives, approximately 25%. Some of the travel will be international.

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