Senior QA Specialist, Supplier Quality and Compliance

Proclinical is seeking a Senior Quality Assurance Specialist, Supplier Quality and Compliance for a cutting-edge biotech company located in Gaithersburg, MD.

The Specialist IV will be responsible for supporting quality systems across the GMP organization including Deviation, CAPA and Change Control systems. The Specialist is expected to work cross-functionally to support robust quality record content and timely completion, and facilitation of documentation of all records within the EQMS (electronic quality management system). This position reports directly to the Senior Manager, Supplier Quality & Compliance.

Must be eligible to work in the US.

Job Responsibilities:

• Manage the day-to-day activities and operations of the Corporate Audit and Supplier Quality Programs.
• Serve as lead corporate and supplier auditor across the network
• Monitor the performance of suppliers while identifying potential issues to improve quality and efficiently
• Effectively collaborate and communicate internally and externally to analyze and resolve complex technical issues in accordance with appropriate quality standards, with minimal input from senior management. Review, track, and trend routine supplier quality data.
• Perform quality review/assessment for potential new suppliers and service providers.
• Execute supplier complaint process with routine reports to management, assess supplier's qualification status and communicate potential risks.
• Independently author and revise controlled documents (e.g.., SOPs, Policies, Protocols, Work Instructions).
• Support negotiation and ensure Quality Technical Agreements (QTAs) are in place with CMOs/Suppliers in preparation for technical transfer or contract manufacturing, contract packaging/labeling for clinical and commercial products.
• Serve as subject matter expert for supplier management during audits and regulatory inspections.
• Identify and support continuous improvement efforts across the quality organization.
• Maintain working knowledge of our documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
• Provides oversight and guidance to junior level specialists.

Skills and Requirements:

• Bachelor's Degree in Biology, Chemistry, Engineering, or related field with 10+ years' experience in the Pharmaceutical/Biotech/Device industry or equivalent experience/education.
• 8+ years of quality systems experience in a Quality organization
• 5+ years industry experience in an auditing role
• Excellent understanding of Quality Assurance systems
• Strong knowledge foundation of FDA and EMA regulations regarding the manufacture of biologics and medical device/combo product (CFR 210, 211, and 820, 610).
• The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.
• Excellent communication skills both verbally and written; and with various organizational levels internally and externally.
• Capable of managing multiple priorities, adapt and maintain adherence to timelines.
• Ability to troubleshoot, identify root cause and systematically resolve problems.
• Ability to communicate clearly and effectively with all levels of the organization.
• PC literacy required; MSOffice skills (Outlook, Excel, Word, SharePoint and PowerPoint). Ability to adapt to changing software programs.
• Demonstrated ability to produce high-quality work on complex problems with cross-functional involvement.
• Anticipates and proactively prevents risks and compromises to quality.
• Demonstrated advanced technical knowledge.
• Demonstrated ability to lead and develop more junior employees.
• Demonstrated ability to manage process improvement projects.
• Demonstrated ability to recognize inefficiencies in the team and identifies improvements constructively.
• Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products
• Ability to apply understanding of the team's place in the larger organization, and discusses changes, progress, and issues as they relate to other areas
• Ability to contribute significantly to cross-functional work. Networks with internal and external peers in own area of expertise.
• The ability to keep colleagues and management apprised of projects and status independently and appropriately; to anticipate future needs based on prior experiences.
• Accountability to reach established goals or targets for moderately complex tasks with the involvement of immediate teammates without compromising commitments.
• The capability to build influence by completing tasks and presenting new ideas; to contribute to cross-functional work; to build relationships internally and coordinates work with others.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or j.cerchio@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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