200+ applicantsPosted by Agency
SciPro ยท 5 days ago
Supplier Quality Manager
United States
Contract
Remote
Director
10+ years exp
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Hiring Manager
Juliette Muratore
Insider Connection @SciPro
Responsibilities
Oversee both internal and external audit programs.
Ensure compliance with the audit schedule and manage the logistics and timing of audits.
Conduct audits in alignment with relevant regulations and guidelines.
Assess audit responses and identify potential risks.
Review supplier compliance with regulatory standards.
Manage supplier questionnaires, including enhancing content, coordinating completion with suppliers, and assessing responses.
Create quality agreement templates and define standard terms.
Lead or facilitate negotiations for quality agreements.
Conduct regular reviews of quality agreements.
Assist in supplier qualification and monitoring processes.
Engage in departmental and cross-functional process improvements and special projects as directed by management.
Contribute to the development of supplier performance metrics.
Perform other duties as needed.
Qualification
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Required
Bachelor's degree in Engineering, Chemistry, or Biological Sciences required.
Minimum of 10 years of experience in quality assurance, manufacturing, QC, or quality engineering.
Experience in auditing and supplier qualification within the biopharmaceutical industry.
Comprehensive knowledge of quality system requirements, including US FDA GMP, GCP, EMA, and ICH guidelines, with a proven track record of successful implementation.
Strong interpersonal, verbal, and written communication skills essential for a collaborative work environment.
Ability to thrive in a fast-paced, small company environment with minimal supervision and adapt to changing priorities.
Excellent organizational skills and ability to prioritize tasks effectively to meet deadlines.
Proficient in MS Word, Excel, PowerPoint, Visio, and Project.
Must be authorized to work in the US.
Some travel may be necessary.
Preferred
Advanced degree or ASQ Auditor/Quality Engineer certification preferred.
Familiarity with Veeva is advantageous but not required.
Company
SciPro
SciPro is a staffing agency specializing in the life sciences field and offers regulatory affairs, biometrics, and clinical operations jobs.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Elizabeth Kennedy
Director & Head of SciPro East Coast
Company data provided by crunchbase
