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Global Compliance Manager

Company: W. R. Grace
Location: Columbia
Posted on: September 25, 2022

Job Description:

Global Compliance ManagerApply now Date:Aug 29, 2022Location: Columbia, MD, US, 21044 Company: W. R. Grace & Co. Requisition ID: 20987 Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The companys two industry-leading business segmentsCatalysts Technologies and Materials Technologiesprovide innovative products, technologies, and services that enhance the products and processes of our customers around the world. Grace employs approximately 4,300 people in over 30 countries.Job DescriptionWe are hiring aCompliance Managerthat will report to the Vice President, Process Technology, Project Execution, Engineering, and Quality, and will be located out of the corporate headquarters in Columbia MD. The Compliance Manager has direct responsibility for the Food and Pharma GMPs, Food Safety, and Quality compliance activities in the Materials Technologies (MT) and Fine Chemicals Manufacturing Services (FCMS) Business Units. This position has corporate oversight and the responsibility for controlling the quality risk associated with Quality Assurance activities that ensure high-quality products and services that meet customer expectations and comply with FDA and international regulations. They will coordinate all FDA compliance for regulated materials as sold into the Food, Pharma, and consumer markets and work closely with the site quality managers, operations, and various business support functions including legal and regulatory. This position requires strong leadership and communication skills as well as a solid understanding of quality processes and FDA-regulated operations. Responsibilities

  • Work closely with the Quality, Operations, product stewardship and legal team to ensure compliance to local and regulatory requirements including global registrations and regulatory strategies.
  • Review and approve global regulatory documentation and registration in support of customers and companys strategic business objectives; including but not limited to Drug Master Files, Annual Reports and Supplements.
  • Act as a GMP SME for Corporate level within change management system.
  • Quality Functional Lead (Quality Independence) for Active Pharmaceutical Ingredient facility or facilities.
  • Manage the food, nutraceutical and pharmaceutical Quality Agreement program working with corporate legal and global facilities. Including but not limited to creating, reviewing, negotiating, approving, and executing Quality Agreements.
  • Establish and conduct Management Reviews with facility team and Senior Management.
  • Execute and routinely update all corporate GMP and food safety related strategies, policies, and procedures; maintain open communication with all related departments to address the identification of GMP and food safety hazards and process improvement opportunities.
  • Establish, conduct, and oversee GMP and Food Safety audits of high-risk suppliers to ensure FSMA and FDA compliance.
  • Work with GMP sites to develop, maintain, and continuously improve standardized policies, operating procedures, work instructions, templates, and other required documents.
  • Conduct both process and analytical validations in support of site level GMPs and define and manage a global master validation plan (MVP). Perform required preventive controls monitoring, including, but not limited to feed/wash water, temperature, allergen control, environmental, metal detection, and sanitation.
  • Research, interpret, and apply regulatory requirements. Ensure compliance with applicable local and international GMP and food safety regulatory requirements. This extends to customer contract review and the development of standard customer compliance statements.
  • Ability to travel up to 30%, globally. Required Qualifications
    • B.S. Degree in Chemical Engineering, Chemistry, or science disciplines
    • 10+ years of relevant experience in GMP, FDA, or API regulated environments and strong quality assurance background
    • Must be a capable leader, able to influence the organization from the shop floor to senior leaders.
    • Solid knowledge of continuous improvement and Lean Six Sigma methodologies (DMAIC, DFSS, Lean). Certified Black Belt preferred.
    • Extensive knowledge of Quality System and Product Regulatory requirements (ISO 9001:2015 / ISO 13485:2006 / cGMP / ICH / FSMA / HACCP / etc.) Preferred Qualifications
      • Knowledge of EU, USP, ICH, FSMA (preferred), IPEC (preferred) WRGRACEBenefitsMedical, Dental, Vision Insurance Life Insurance and Disability Grace Wellness Program Flexible Workplace Retirement Plans 401(k) Company Match Dollar to dollar up to the first 6% Paid Vacation and Holidays Parental Leave Tuition Reimbursement Company Donation Match Program #WRGrace Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.Nearest Major Market:Baltimore Apply now Find similar jobs:

Keywords: W. R. Grace, Baltimore , Global Compliance Manager, Executive , Columbia, Maryland

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