Compliance Team, Inc.

  • Technical Project Managers

    Job Locations US-MO-St. Louis
    Posted Date 4 weeks ago(6/21/2018 3:40 PM)
    ID
    2018-1234
    # of Openings
    3
    Category
    Management
  • Overview

    Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects.

     

    This position will assume a leadership role to manage projects in support of the development/implementation of manufacturing processes of new Auto Injectors products at the site. In addition, this position will also manage projects to maintain existing Auto Injector products to be in compliance with regulations and or customer requirements.  The position will be responsible to oversee the development and maintenance of project timelines and cost information for the site and to work with the project teams to ensure execution to project plans meets expectations. 

     

    The position will be responsible to asses risk, develop mitigation plans and to lead regular team meetings working cross functionally with the sites Manufacturing, Quality Assurance, Quality Control, Validation, Technical and Regulatory departments.  Interaction with colleagues outside the site and with customers will also be required.  The position will be required to report on a regular basis to the sites leadership team.  The new products and processes developed must allow for manufacturing to occur in compliance with cGMP’s, regulatory standards, company policies and site processes. 

     

    Responsibilities

    • Manages key projects utilizing effective project management tools in order coordinate the introduction of new processes and products into the site.
    • Ensures project plans are developed and maintained to meet the needs of the site and customer using appropriate risk mitigation strategies.
    • Conducts routine project review meetings with team members to ensure timelines and projected costs are met.
    • Assess risk and ensures that issues are discussed within the team and with the sites leadership.
    • Drives project team accountability.
    • Ensures that the project teams interact with the sites Validation, Manufacturing, Quality, Technical and Regulatory departments, at appropriate levels,  to ensure execution of project tasks.
    • Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls.  Note that these activities may not be time bound to core hours or presence at the site.
    • Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.

     

    Qualifications

    • BS/BA, MS or PhD in a relevant discipline.  Certifications:  Project Management Professional (PMP).
    • A minimum of 10 years of pharmaceutical development and or manufacturing experience in a cGMP environment is required for this position.  Experience and knowledge in the development of parenteral liquid drug products with device design controls, mold/tooling build and design for componentry, analytical chemistry and experience with auto injector design/function will be required.
    • Knowledge of cGMPs and regulatory requirements as related to the manufacture, testing and quality of parenteral products.
    • Project management tools
    • Good interpersonal skills; collaborative approach; team player.
    • Demonstrates attention to detail.
    • Excellent organizational skills.
    • Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies
    • Demonstrates self-sufficiency, able to work under limited supervision.
    • Experienced in meeting the expectations and requirements of internal and external customers.
    • Makes decisions of moderate complexity, sometimes with incomplete information and under tight deadlines and pressure. Makes sound decisions based upon a mixture of analysis, wisdom, experience, and judgment. Always acts with integrity.
    • Deals with concepts and complexity comfortably – intellectually sharp, capable and agile.
    • Understands when to inform, consult or escalate. Summarizes information succinctly and accurately and provides clear recommendations based on a combination of the information at hand and regulatory/procedural guidance.
    • Presentation skills, computer literate (MS WORD, Excel, PowerPoint, QTS, Lotus Notes).
    • Review and approve cGMP Changes in accordance with regulatory requirements
    • Review and approve training to assure cGMP requirements are met
    • Manage Resources to meet organizational goals
    • Understand site financial systems
    • Understand Safety concerns and maintain safe environment (5S, ergonomics)
    • Ability to perform GMP assessments for new & revised PQS
    • Ensure participation in company-wide knowledge exchanges
    • Ensure all drug products comply with applicable compendia requirements and are manufactured under cGMPs.

    Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis. This manager’s work will be accomplished while sitting, walking and standing.  Attendance and participation in various departmental and site leadership team meetings will also be required. This position will require travel between the sites multiple locations (approximately 10 miles apart) and occasional travel outside of St. Louis.



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