Insmed Incorporated

  • Director Quality GMP Compliance

    ID
    2019-1140
    Job Function
    Quality Assurance
  • Company Description

    Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

    Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.

    Overview

    Reporting to the Head of Quality Assurance GMP, the Director Quality GMP Compliance will play a key role in setting strategy and managing QA Global Regulatory GMP Compliance activities for Insmed in both the US and across global sites.  This individual will be responsible for setting strategic direction in Supplier Quality Processes & Risk Management, GMP Inspection Readiness, QMS, and Internal Audits.  This position will be a senior leader in the Quality Organization and will partner to ensure overall effectiveness of the Quality Organization within Insmed.  The scope of this role includes commercial and development (clinical) GMP.

    Responsibilities

    • Create, maintain/update and monitor the Supplier Quality program. Responsibilities will include creating/reviewing SOPs, key performance indicators, supplier audit schedule, supplier audits, reports, certificates, CAPAs, supplier Quality Agreements, selection process, qualification process, monitoring process, supplier surveys, approved supplier lists and annual audit schedule, amongst ad hoc needs.
    • Review and provide input into Veeva system capabilities – create, maintain and update supplier files in Veeva, updating the process as applicable.
    • Partner with QA Leadership and Supply Chain partner in the creation of a Quality Risk Management Strategy for critical suppliers including communication plans, “person in plant” approach, joint steering committee topics, QA-QA meetings and performance metrics, in addition to any other identified needs.
    • Partner with QA Leadership to ensure GMP inspection readiness programs at global locations including on-going SME training, simulations, contact lists, introduction presentations and standard request readiness (complaint lists, deviation lists, SOP index, etc.). For US activities, act as the primary health authority inspection host and/or back room lead.
    • Create, maintain/update and monitor the internal audit process for GMP related activities including the annual schedule, reports and CAPA monitoring.
    • Primary individual responsible for Global QMS documents - including the development and revision of the Global Quality Manual, Quality Policy, and Standards.
    • Partner with business stakeholders and QA Leadership to ensure overall effectiveness of the Global Quality Organization.
    • Create and maintain Standard Operating Procedures relating to areas of responsibility including Supplier Quality, Internal Audits, Health Authority Inspections, Quality Agreements, Quality Manual, and Standards.
    • Support site inspection readiness activities through simulations, front/back room roles, training, etc.
    • Act as company’s representative with regulatory agencies and customers.

    Qualifications

      • BS degree in Chemistry, Engineering, Life Science or related discipline required.
      • A minimum of 10 years of relevant Quality Assurance experience of increasing levels of responsibility required. Candidates with an advanced degree (MS) and a minimum of 8 years relevant experience will also be considered.
      •  
      • Must be thoroughly knowledgeable on Global drug cGMP's, ISO 13485, ISO 14971 and familiar with other Regulatory Requirements applicable to a medical device and combination product manufacturing operation.
      • Direct Global Quality experience.
      • Must have had Health Authority inspection experience.
      • Must have direct experience with GMP compliance responsibilities, Inspection Readiness Programs, and Supplier Quality in pharmaceutical and/or medical device products.
      • Experience with internal and external audits.
      • ASQ CQE and CQA Certification preferred.
      • Must be able to partner and collaborate well cross functionally, at all levels.
      • Must have excellent communication and influence skills (verbal and written).
      • Should demonstrate the ability to manage projects and variable workloads.
      • Acts in a highly organized manner with a strong attention to detail, clarity, accuracy and conciseness.

    Additional Information

    Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

     

    Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

     

    Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.

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