Quality Assurance Compliance Specialist IV, Quality Systems Compliance

Gaithersburg, MD

Posted: 06/30/2023 Industry: Scientific Job Number: 23-00294

Job Description

Quality Assurance Compliance Specialist IV,  Quality Systems Compliance
Potential for some hybrid flexibility but onsite about 4 days per week.

Description
Responsibilities include but are not limited to:
  • Serve as an expert in the quality review and approval of complex QMS records including deviations, CAPAs, and change controls, and as QA Super User for EQMS
  • Effectively facilitate cross-functional and multi-site meetings including CCRB and Quality Escalation
  • Manage and coordinate Global Management Review including generation of metrics, scheduling presenters, preparing documentation, and follow up of Action Items assigned during meetings. Also lead the identification of improvement initiatives for quality system key performance indicators that are not meeting expectations.
  • Serve as subject matter expert for quality systems during audits and regulatory inspections, including demonstrating knowledge of audit management software.
  • Identify and support continuous improvement efforts across the quality organization.
  • Author and revise QMS documents including SOPs and Work Instructions
  • Maintain working knowledge of documentation (including Quality Manual, Policies and SOPs) and relevant GxP regulations and guidelines related to US and EU compliance.
  • Serve as internal subject matter expert for changes in GxP expectations, including FDA, EU and other relevant foreign regulatory bodies, guidance documents (i.E.: ICH, PTC, ISPE, etc.), and best industry practices.
  • Effectively collaborate and communicate with departments across the company to analyze and resolve technical issues in accordance with appropriate quality standards.
  • Provides oversight and guidance to junior level specialists.
Minimum 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
  • Expertise in managing quality systems such as deviations, change controls, and CAPAs.
  • 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 to .
  • Capable of managing multiple priorities, adapt and maintain adherence to timelines.
Preferred Requirements:
  • Demonstrated ability to lead complex investigations with minimal supervision.
  • Demonstrated advanced technical knowledge.
  • Demonstrated ability to lead and develop more junior employees.
  • Demonstrated ability to manage process improvement projects.
  • Demonstrated knowledge of quality systems regulatory requirements for medical device or combo products
  • 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.

Meet Your Recruiter

Clarence Alphonso

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Revised 12/14/2022

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About Gaithersburg, MD

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