Job: Specialist / Senior Specialist, Quality: Supplier Quality Management (SQM), Beam Therapeutics, RTP, NC
Specialist / Senior Specialist, Quality: Supplier Quality Management (SQM)
RTP, NC 27709 United States
The Specialist, Quality will report into the GMP Quality Operations team and will support cGMP activities for supplier oversight including onboarding and managing raw material suppliers and GMP service providers for the North Carolina manufacturing site. The position will be critical to the site start-up project for Beam in support of broader organization moving products through the clinical pipeline to commercial launch and growth.
The Specialist, Quality will have responsibility to assure initiatives related to quality and compliance are optimized and executed appropriately in the areas of GMP compliance with Beam’s suppliers. The position will support identification of suppliers as required, qualification of suppliers and management of the Approved Supplier List for Beam NC. In addition, the position will partner with External Quality to manage shared suppliers across Beam’s GMP network. The position will coordinate supplier data and conduct appropriate review of deliverables (records, test results, etc.) as required. This position will also support Beam NC’s start-up where quality operations support is required (ex. Quality support in for site start-up, CQV and change management, technical transfers, material disposition, etc.).
The Specialist, Quality (SQM) is expected to be on-site resource for project start-up with option for flexible work arrangement with remote work some percentage of time depending on current work assignments.
Qualify and onboard suppliers and GMP service suppliers for Beam NC including managing supplier status, coordinating and conducting audits as required, and managing Approved supplier list.
Quality Assurance representative for ongoing supplier management to provide quality system expertise and help identify solutions and ensure compliance to GMP
Perform Quality review data, reports, executed records, and other documentation from suppliers as required.
Review and approve supplier deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
Work collaboratively with cross functional teams, partners, and suppliers to gather background knowledge needed to complete assignments.
Provides quality assurance guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
Drafts and reviews SOPs and related GMP documents.
Provide QA support to operations start-up and routine production activities
Supports analytical method qualification, method transfer, and lab investigations at contract laboratories as necessary.
Applies strong technical expertise of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems.
Travel may be required to support audits and other assignments as applicable.
Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
10+ years of relevant experience in a GMP environment with at least 4 years with pharmaceutical quality experience is preferred.
Direct experience with managing suppliers and executing supplier audits.
Working knowledge of US and EU cGMP regulations and guidance.
Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, and analytical testing is preferred.
Independently troubleshoots problems and issues; called upon to train or assist others for a large portion of the job.
Provides consistently prompt, efficient, dependable, highly skilled service.
Demonstrates consistent judgment, quality, accuracy, speed, and creativity.
Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance.
Understands, selects, and uses appropriate risk management and root cause analysis tools.
Takes initiative in making improvement suggestions to promote operational goals.
Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
Reflects solid understanding of strategies and goals and can take part in major parts of projects or provide expert service.
Recommends improvements to on-going processes and projects.
Facilitates designing processes with Quality built in from the beginning.
Identifies, and uses good judgement to handle out-of-compliance situations.
Good listening and communication skills.
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