• Lead, Quality Compliance

    Location US-IL-Chicago
    Posted Date 1 week ago(1 week ago)
    ID
    2018-2195
    Company
    Adello Biologics, LLC
  • Overview

    Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com

     

    Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Lead, Quality Compliance to be based out of our Chicago, IL location.

    Responsibilities

    SUMMARY:

    • The Quality Compliance Lead is a full-time exempt position at Adello Biologics, LLC, in Chicago, IL. The successful candidate will work with the Quality Compliance team to implement and maintain CGMP compliant systems at Adello while providing the functional and strategic leadership to ensure Adello’s quality systems are in a state of control and meet with industry standards. One of the key responsibilities of this role is to oversee Adello’s Supplier Quality program which includes performing supplier audits. The successful candidate will be expected to manage a broad spectrum of projects, to support the needs of Quality Management. This position interacts with all departments within Adello and liaises with customers, CMOs, regulatory authorities, third party auditors and suppliers regarding quality matters.

     

     

    Essential Duties and Responsibilities:

    • Develops and implements quality assurance procedures governing Quality Systems and ensures compliance with cGMP regulations, customer expectations and company policies.
    • Ensures suppliers are evaluated for quality and performance and approved per procedures to ensure incoming material meet Adello standards and CGMP.
    • Conducts supplier audits globally as well as within the US. Maintains strong supplier relations and interfaces with suppliers to resolve any quality findings, supplier complaints, change notifications etc.
    • Prepares Supplier Quality Agreements to ensure quality requirements and responsibilities are clearly defined.
    • Leads the internal audit program to monitor Adello’s state of compliance. Identifies and resolves any non-conformance issues and ensures audit findings are addressed in a timely manner.
    • Prepares and manages audit schedules, audit plans, audit reports and responses.
    • Works with Contract manufacturers to resolve any quality issues and provides quality oversight over CMO operations for Adello products.
    • Performs data integrity audits to ensure compliance with 21 CFR 11 requirements.
    • Performs gap assessments, generates quality and compliance plans and drives the implementation of quality objectives.
    • Monitors effectiveness of Quality Systems, generates Quality System event metrics and trend analysis for management review, escalates issues and drives resolution.
    • Monitors and investigates product complaints. Works with a cross functional team to identify root cause and implement necessary CAPAs.
    • Stays current on compliance matters, recent 483’s / warning letters, regulations and industry trends.
    • Involved in developing, modifying and executing company policies that impact operations.
    • Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
    • Prepares and revises technical documents (deviations, change control, OOS investigations, CAPAs, SOPs, etc.).

     

     

    Qualifications

    PREREQUISITES:

    Education / Experience:

    • BS degree in life sciences (Biology, Chemistry, etc.) with 10+ years’ relevant industry (Biotech/Pharma) experience.
    • MS degree in life sciences with 7-10 years’ relevant industry (Biotech/Pharma) experience.
    • Knowledge of CGMPs and their application in the commercial environment.

    Certification:

    • ASQ certified quality auditor (CQA) preferred

     

    SPECIALIZED KNOWLEDGE AND SKILLS:

    • Ability to work independently or in teams both within department and cross-functionally. Must be able to organize, plan and manage assigned tasks to bring projects to completion.
    • Strong and clear communication skills, both written and verbal.
    • Extensive experience with conducting CGMP audits. Experience with GLP and GCP audits is a plus.
    • Has knowledge and experience auditing and/or working in an aseptic processing facility.
    • Has familiarity with Code of Federal Regulations (CFR) guidelines, ICH guidelines, USP, CGMP and EMA guidelines.
    • Strong technical writing skills.
    • Requires the ability to influence and works with a high level of integrity, is diplomatic, objective and resourceful.
    • Leadership skills with ability to direct and drive projects to completion in a timely manner.
    • Excellent computer skills in Microsoft Office applications.

     

    WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

    • Typing, desk work and facility auditing.
    • Some brief and/or minimal exposure to hazardous chemicals may occur, requiring personal protective equipment.
    • Safety alertness is required due to work around hazardous equipment and conditions.
    • Travel may be required for supplier audits, approx. 20% of work time.

     

     

    Noise:

    • Noise levels commensurate with shared office space.

     

    Standing/Lifting:

    • No extraordinary requirements

     

                           

    Visual:

    • No extraordinary requirements.

     

    Stress:

    • High-paced demanding environment to meet ambitious project goals.

     

     

    Travel:

    • Approximately 20% of work time

     

    Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

    Notice To Agency And Search Firm Representatives  

    Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

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