Senior Staff Quality Specialist - QMS, Labeling # 4310

Responsibilities:

• Support Quality Operations through expert interpretation, establishment, and execution of  quality concepts and principles in accordance with GRAIL’s quality management system  and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR,  CAP/CLIA/NYSDOH, ISO 15189, and related regulations and standards. 
• Use proactive, creative problem-solving to contribute to development of concepts and  principles to achieve goals and objectives. 
• Demonstrate technical proficiency, creativity, teamwork, collaboration with others, and  regular independent thought. 
• Exercise excellent judgment within broadly defined practices and policies in selecting  methods, techniques, and evaluation criteria for obtaining results. 
• Act independently to determine methods and procedures to successfully complete  assignments. 
• Structure day-to-day work autonomously, effectively communicating status and issues with  management. 
• Identify and evaluate deficiencies and improvement opportunities, working cross functionally to resolve and improve on existing processes. 
• Create and support a quality culture by driving compliance activities around the Change Control, Planned Deviation, and Complaint Handling/Post Market Surveillance Programs, partnering across the organization to manage continuous process/quality improvements that strongly align with GRAIL procedures and customer (internal and external) needs while meeting all applicable regulations and standards.
• Lead and support quality system process improvements, workflow implementations, and system configurations associated with the Change Management, Planned Deviation, Complaint Handling/PMS, Product Labeling, Packaging/Distribution, and other Programs.
• Partner with GRAIL Customer Service Team and Medical Information Team to facilitate feedback evaluation, complaint investigations and closure across all GRAIL sites. Perform assessments for reportability on adverse events, impact/risk, and trend analysis.  
• Collaborate and provide mentorship to change owners, approvers, and cross-functional owners, ensuring effective implementation of change. Evaluate and identify areas of noncompliance, risk and/or potential improvement to management and develop plans for appropriate action to address causes of deficiencies.
• Provide Quality oversight, including review, feedback, and approval for Change Control, Planned Deviation, and Complaint Handling/PMS Programs.
• Provide Quality oversight, including review, feedback, and approval for Veeva workflows for new and revised product labeling, packaging component, and finished product packaging/distribution specifications.
• Respond to all inbound change management, planned deviation, and complaint related inquiries and maintain effective cross-functional team communications to advance GRAIL’s quality activities and promote standard methodologies.
• Support generation of Quality Systems metrics, which roll up to Quality Indices and Key Performance Indicators, and Quality Management Review. 
• Cultivate positive relationships with key partners, leadership team members, and other cross-functional partners throughout GRAIL, including third-party vendors/consultants.
• Implement programs to comply with all applicable regulatory requirements including 21 CFR 820, ISO 13485, and ISO 14971, IVDR, ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH), and related regulations and standards. 
• Represent Sustaining and Post Market Quality on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.
• Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement. 

Preferred Qualifications:

• Degree in science, engineering, or other technical area, or equivalent experience.
• 10 + years of experience working within a medical device, pharmaceutical, or biotech quality management system, with at least 5 years direct involvement in administering Change Control, Planned Deviation, Complaint Handling, and/or Product Labeling programs.
• Experience using an eQMS, preferably Veeva Quality Suites.
• Working knowledge and understanding of regulations and standards, including but not limited to QSR, ISO 13485, Quality System, CAP/CLIA, NYS, ISO 15189 and other applicable industry requirements.
• Proven ability to efficiently manage workload under tight deadlines and pressure in a composed manner.
• Demonstrated ability to perform meticulous work with a high degree of accuracy and completeness.
• Demonstrated project management experience developing processes and leading their implementation in a cross functional environment.
• Experience supporting regulatory inspections/audits and responding to findings.
• Excellent written and verbal communication skills.
• Proficiency with standard office software applications including Microsoft Office, Google Suite, and Zoom