Manager, Materials Quality
Hays

Job Info

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The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

An American Company is seeking a Manager, Materials Quality in Gaithersburg, MD.

Role Description

We are seeking a Manager, Materials Quality to join our Quality Ops Materials department in Gaithersburg, MD. The qualified individual should have experience in receipt and inspection of Raw Material documentation submitted for QA disposition, write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications. This position reports directly to the Director, Material Quality Assurance.

• Leads and manages employees, ensures staff is fully trained, works with employees to ensure development opportunities occur, and mentor staff.
• Strong knowledge of analytical techniques and instrumentation, such as gas and high-performance liquid chromatography (HPLC), ion chromatography, and spectroscopy (infrared and ultraviolet, amongst others)
• Review Method Validation Protocols / Reports and QC Methods as needed
• Evaluate specification for existing products and new R&D formulations
• Track status of all Material Review Board (MRB) material and Interface on a daily basis with various departments to provide status of open MRB items and to seek closure on those items.
• Interpret data and meet strict guidelines on documentation when recording data Identifies compliance risks and works cross-functionally to identify and implement resolutions. Escalates significant compliance and/or business risks to management.
• Author, review, and approve Standard Operating Procedures as it pertains to Raw Material Disposition and Material Specifications
• Perform receipt inspection and critical reviews of Raw Material documentation submitted for QA disposition\
• Write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material SpecificationsTrack and trend raw material release data for Quality metrics\
• Respond to various interdepartmental requests. Answer questions and provide feedback to ensure Quality and departmental objectives are met
• Keep management informed of concerns/issues/successes
• Approving documents that justify in-process controls and in-process specifications
• Approve specifications including but not limited to raw materials, components, finished product, labels, SOP's, testing procedures and deviations.
• Approve documentation for supplier management process (e.g.; approval to use, qualified to accept Certificate of Analysis (CoA), etc.)
• Review change controls and assesses for Quality Impact Works to continuously improve and streamline the raw materials release system.
• Work with Quality system activities related to sampling, review and disposition of raw material and consumables.
• Provide quality oversight of Raw Material Release activities
• Accountable to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments

Skills & Requirements

• Bachelor's degree in biological science or technical discipline.
• 7+ years' experience in GMP pharmaceuticals, biologics and/or vaccine manufacturing.
• 3+ years' experience in a supervisory role.
• 4+ years' industry experience in an auditing role.
• Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) in a development to commercial application setting.
• Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics (210, 211, and 610 CFR and Eudralex Vol 4), including regulatory inspection or support experience is preferred.
• Knowledge and experience in auditing formulation/fill finish manufacturing and material suppliers.
• Excellent multi-tasking, analytical, organizational and leadership skills.
• Ability to troubleshoot, identify root cause and systematically resolve problems.
• Ability to communicate clearly and effectively with all levels of the organization.
• Proficient in Window based software to include Excel, Word, and Access. Ability to adapt to changing software programs.
• Strong communication and organizational skills

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the Information Technology industry and market trends . Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

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Hays is an Equal Opportunity Employer.

Drug testing may be required; please contact a recruiter for more information.
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