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Quality Systems Manager

Location: San Diego, CA, United States
Job # 11567555
Date Posted: 11-05-2018
Quality Systems Manager
San Diego, CA 92121
6 Month Contract (Strong Potential to Convert)
Pay: Depends on Experience
Start Date: ASAP
Client Overview
Our client is a clinical late-stage biotechnology company engaged in the development of biosimilar therapeutics and high-value and difficult to manufacture proteins. We have the highest-quality protein production and bioanalytic technology platform approach that allows us to create biosimilars in a highly efficient manner from concept to commercialization.

Job Description
We are looking for a Quality Systems Manager to be a key member of our in-house Quality Group. In this role, you will oversee the development, implementation and maintenance of GxP quality systems and activities, including document control activities. You will also be responsible for implementing the quality system including, but not limited to, the applicable standards, policies and procedures in assigned areas of responsibility. The ideal candidate will have quality assurance experience working in the biotech/ pharmaceutical sector.

  • Develops, implements and maintains quality systems, both paper-based and electronic
  • Manages systems to ensure compliance with QA procedures such as CAPA, change control and investigations
  • Leads implementation, validation, and ensures the ongoing compliance of electronic document management systems (EDMS)
  • Manages document control and acts as subject-matter-expert (SME)
  • Develops and presents GMP training sessions for our internal employees
  • Manages and tracks employee training records
  • Participates in the evaluation of our Quality System and processes for optimization and continuous improvement
  • Performs quality reviews and reports quality system metrics to key stakeholders including compliance metrics and trending
  • Reviews and approves controlled documents for adherence to quality standards (e.g., SOPs, validation, master batch records, analytical test records)
  • Trains EDMS end users and provides first-line technical support
  • Other duties as assigned or required
  • 8+ years of experience working in a biotech or pharmaceutical quality assurance environment; progressive career required
  • 2+ years of experience working in a similar role required
  • Passion for biotechnology/science is required
  • Ability to build relationships and work collaboratively with a variety of individuals within the department, company and external vendors, and customers alike
  • Ability to effectively multi-task to meet deadlines and commitments
  • Ability to lead, manage, influence , and motivate others to support objectives and mission and to achieve goals set out
  • Ability to work flexible work schedules, including weekends, as required
  • Ability to work in fast-paced, team-oriented and self-directed entrepreneurial environment
  • Appreciates and respects the necessity for confidentiality
  • Attention to detail and proper use of tools of information processing and electronic documentation systems
  • Compiles, creates and analyzes reports with metrics and results as required
  • Demonstrated abilities and well-versed in US and international pharmaceutical regulations, guidelines and expectations (FDA GMP, EU GMP, EU Directives, ICH Guidelines, etc.)
  • Demonstrated ability to read and interpret complex information easily and communicates data back in a logical, effective and actionable manner
  • Demonstrated and proven ability to work in a lean organization and creatively tackle problems using personal, professional and collegiate networks as well as publicly available solutions
  • Demonstrated and proven track record in all phases of drug development, from IND filing through commercialization
  • Demonstrated, proven and effective project- and time-management abilities and follow-through skills required
  • Exceptional analytical, organizational and communication skills (verbal, written, presentation) required
  • Exceptional listening, observational and problem-solving skills
  • Significant experience using computers and software programs required (e.g., MS Office Suite and Adobe Acrobat software; Documentum, Master Control, and Veeva or similar softwares)
  • Stays confident when challenged, stating the rationale for one's views clearly while listening to and respecting others' right to different opinions; works well as part of a multifunctional team
  • Other skills and abilities as required
Supplemental Experience as a Strong Plus
  • Experience working in a drug-development organization; biosimilars development preferred
  • Experience in a publicly traded biotech/pharma/scientific-related company preferred
  • Experience working in a start-up or fast-growing company preferred
  • BA/BS degree in life sciences, engineering or a related discipline required
Please submit your resume in PDF or Word format to be in consideration. #DI
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