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Manager/Sr. Manager, Quality Assurance Document Control

Company: Ascent
Location: Mountain View
Posted on: November 16, 2021

Job Description:

Ascent Life Sciences is hiring a Manager/Sr. Manager, Quality Assurance Document Control. As the Manager/Sr. Manager Quality Assurance Document Control you will have the responsibility to serve as a subject matter expert and will provide oversight and continual improvement of our GxP Document and Records Management system. The incumbent will provide support and promote collaboration to ensure all systems, processes and their outcomes are compliant with GxP guidelines, and applicable international and national standards, regulations and guidelines. The Manager/Sr. Manager, Quality Assurance Document Control will act as a representative during regulatory agency inspections for Document Control. This will be a hands-on role reporting into the Associate Director/Director, Quality Systems. RESPONSIBILITIES Manage document control processes and systems for GxP activities in compliance with internal procedures and policies as well as regulatory requirements. Assist in the implementation of GXP compliant procedures and operations to ensure a robust quality management system for both the conduct of clinical studies as well as prepare the company to successfully commercialize clinical products. This involves writing and maintaining document control procedures and participating in the development and roll-out of document control tools. Manage the routing, review, approval, distribution and archival of new and revised controlled documents. Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedures. Develop and deliver training and/or site guidance on document and records management roles, and processes. Assist with the organization, preparation, coordination, and documentation of regulatory inspections. Develop and measure quality metrics to drive consistent quality standards throughout the organization for document management. Define resource requirements; assign resources to tasks; manage assigned team. Provide direction and guidance to managed team in regard to prioritization, deliverables and career development. Establish and adhere to functional area budget, including the identification and allocation of capital expenditures and resource needs. QUALIFICATIONS & KEY ATTRIBUTES: Bachelor's degree in scientific or related discipline 5+ years of Quality experience in the biotechnology, pharmaceutical, or cellular therapy industry with a minimum of 1-3 years in Quality Management Prior experience in interaction with Global Health Authority reviewers/investigators and pre-submission meetings Working knowledge of global regulations and standards, including FDA, EMA, ICH, and PMDA Manages multiple personnel within the team directly or in a matrixed team Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment Ability to communicate and work independently with scientific/technical personnel Excellent technical writing and editing skills Well organized with ability to multitask in a fast-paced environment Advanced skills with MS Office applications Word, Excel, Access, as well as Adobe Acrobat and experience with Veeva is a Plus For immediate consideration please email your resume for consideration to me at

Company Description:

About Ascent: Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent's fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts. If you are ready to propel your career to new heights--- read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.

Keywords: Ascent, Mountain View , Manager/Sr. Manager, Quality Assurance Document Control, Executive , Mountain View, California

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