ProSciento, Inc.

  • Clinical CRO Quality Leadership

    Job Location US-CA-San Diego
    Posted Date 1 week ago(8/7/2018 11:28 AM)
  • Overview

    Summary: Provides leadership and management to the quality assurance department in the development, implementation, administration, and documentation of ProSciento’s quality management system and its associated standards and systems to ensure that clinical trials are conducted, and data is generated, documented, and reported in compliance with internal standards, GCP, ISO 9001, and relevant and applicable regulatory requirements. Performs duties in accordance with ProSciento’s values, policies, and procedures.

     

    Please note: Depending on candidate experience, ProSciento is currently open to consider a Senior Manager or Associate Director for this role.

    Responsibilities

    Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.

     

    • Directs supervision and management of quality staff including creation of individual development plans, fostering team building, positive communication, and corporate culture.
    • Plans and coordinates implementation and management of quality systems, processes, and procedures to ensure compliance with all applicable regulations (GCP, GLP, GMP, ICH) and state laws, and to meet ISO standards for clinical trials in applicable phase research, including processes related to:
    • Audits and Inspections
    • CAPA (Corrective and Preventive Action)
    • Document Management System
    • Medical Equipment and IT
    • Training
    • QMS Metrics and Trending
      • Maintains quality files related to internal and external audits, and CAPAs.
      • Oversees and supervises creation of periodic QMS metrics and trend analyses.
    • Maintains current knowledge and understanding of GCP, applicable regulations, and ISO 9001 requirements. Provides feedback and training on requirements and advice/guidance on how to comply with the requirements.
    • Develops, trains, and encourages ISO 9001 approach across organization.
    • Assists all levels of the quality leadership team as needed.
    • Audits and Inspections
    • Oversees, supervises, plans, and conducts internal audits, including provision of recommendations for improvement and tracking/reporting of findings and resultant actions.
    • Participates in sponsor initiated audits and supports regulatory inspections. Assists in tracking/reporting of external findings and resultant actions.
    • CAPA (Corrective and Preventive Action)
      • Oversees and supervises quality staff in CAPA process from reactive perspective. Ensures effective evaluation and tracking of corrective and preventive action plans, as applicable.
    • Document Management System
    • Oversees management of eDocument Management System (eDMS) for Standard Operating Procedures (SOPs), Work Instructions (WIs), and Associated Documents (ADs), including quality review during development and maintenance of controlled procedures.
    • Oversees and supervises development and maintenance of appropriate QMS documentation including quality policies, SOPs, training, and equipment records as needed to comply with regulatory, ISO, and reasonable sponsor requirements.
    • Medical Equipment
      • Understands and guides process for compliant management of ProSciento medical equipment.
      • Coordinates and plans quality activities related to management of information technology (IT) system validations specifically related to equipment requirements for clinical trials.
    • Training
      • Coordinates all staff training, as needed.
      • Oversees and supervises management of general training documentation.

     

    ☐ Additional Duties and Responsibilities for Senior Manager, Quality

    All duties defined in level one, and in addition:

    • Audits and Inspections
      • Leads scheduling and assignment for internal audits and assists with initial and continuing suitability evaluations for third-party vendor audits.
    • Medical Equipment
    • Oversees and supervises compliant management of ProSciento medical equipment.
    • Oversees and drives quality activities related to management of IT system validations specifically related to equipment requirements for clinical trials.

     

    ☐ Additional Duties and Responsibilities for Associate Director, Quality

    All duties defined in levels one and two, and in addition:

    • Oversees, coordinates, and provides senior leadership and strategic direction for the quality assurance and quality control departments.
    • Communicates cross departmentally regarding quality strategy, issues, and processes.
    • Audits and Inspections
    • Leads preparation for and conduct of sponsor-initiated audits, when applicable.
    • Coordinates preparation activities during regulatory inspections.
    • Oversees qualification process for third-party vendors to support CRU and CRO activities.
    • CAPA (Corrective and Preventive Action)
      • Oversees and supervises quality staff in CAPA process from both a proactive and reactive perspective. Ensures effective evaluation and tracking of corrective and preventive action plans, as applicable.
      • May participate as CAPA Board Member, in a back-up capacity.
    • Document Management System
      • Functions in back-up system administrator role, if required.
    • Training
      • Plans and oversees management of continuing education requirements for applicable personnel as defined by certifications and job functions, and as relevant to the organization.

     

     

    Supervisory Responsibilities:

    Manager through Director levels:

    • Assists in management of the quality team and carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
    • Responsibilities include workforce planning, interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

    Qualifications

    Qualifications:

    To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    ☐ Manager, Quality Education and Experience:

    Minimum of bachelor’s degree from four-year college or university in life sciences or related field. Minimum of 3 years QA experience in the clinical area of a pharmaceutical, CRO, or medical device company, or related organization. Minimum of 2 years management experience in clinical quality. Equivalent combination of education and experience may be substituted.

     

    ☐ Senior Manager, Quality Education and Experience:

    Minimum of bachelor’s degree from four-year college or university in life sciences or related field. Minimum of 5 years QA experience in the clinical area of a pharmaceutical, CRO, or medical device company, or related organization. Minimum of 3 years management experience in clinical quality. Equivalent combination of education and experience may be substituted.

     

    ☐ Associate Director, Quality Education and Experience:

    Minimum of bachelor's degree from four-year college or university in life sciences or related field. Minimum of 5 years QA management experience. Minimum of 5 years clinical trial management and/or QA experience. Minimum of 2 years ISO 9001 experience. Equivalent combination of education and experience may be substituted.

     

    Skills, Knowledge, and Abilities:

    Manager through Director levels:

    • Advanced knowledge of US and International Regulatory requirements for clinical research including FDA/ICH-GCP; knowledge of ISO 9001; demonstrated leadership skills; strong judgement, initiative, and problem-solving skills; high level team development and leadership skills, strong communication skills.

     

    Language Skills:

    Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, employees, and the general public.

     

    Math Skills:

    Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.

     

    Reasoning Skills:

    Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

     

    Computer Skills:

    To perform this job successfully, an individual should have excellent computer skills with intermediate to advanced computer skills in the current Microsoft Office Word, Excel, and PowerPoint, as well as Window applications. Must have electronic document management experience. Ability to quickly learn and use new software systems.

     

    Work Environment:

    The work environment characteristics described here are representative of those an employee may encounter while performing the essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

     

    While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; work in high, precarious places and fumes or airborne particles. The noise level in the work environment is usually quiet to moderate.

     

    Physical Demands:

    The physical demands described here are representative of those that must be met by an employee to successfully perform essential job functions. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

     

    The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close, distance and peripheral vision as well as depth perception and the ability to adjust focus. While performing the duties of this job the employee is regularly required to sit, talk and hear. The employee is frequently required to stand; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to walk, stoop, kneel, crouch, or crawl.

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed