Sr. Quality Manager (v679)

  • Contract Duration: 6+ months, potential to extend or convert, Hybrid or Remote
  • Research & Development
  • Boston, MA

Website Lenox Executive Search


Sr. Manager Quality Assurance

Area: Research and Development Quality


  • Supporting R&D Quality
  • Looking for someone with good communication
  • Looking for the right candidate to fit the team, can be somewhat flexible on JD requirements

General position summary:

The Senior Quality Manager, Quality and Risk Management in R&D Quality is part of the Company’s Quality Assurance Organization, and is responsible for performing GCP quality assurance oversight and management activities of clinical trial operations to ensure Company’s trials are conducted in accordance with Good Clinical Practice (GCP) guidelines, applicable regulations, protocols and Company’s policies and procedures. These activities include the development and execution of study level audit plans, accurately identifying and communicating compliance risks and overseeing action plans to mitigate risks, monitoring quality issues and compliance metrics, investigation and CAPA management and proactive inspection readiness activities.

*** Experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics is advantageous. This individual is responsible for adhering to the Company’s quality standards as set forth in the Quality Management System (QMS).

Position may require up to 10% national/international travel.

Key Responsibilities:

· Serves as the Quality Lead for assigned clinical programs providing GCP compliance interpretation, consultation, and other supportive services necessary to maintain and/or improve the quality of Company’s research to ensure the protection of subjects’ safety, rights, and well-being as well as the integrity and credibility of data generated.

· Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).

· Liaise with Company’s clinical functions and external parties including CROs, Vendors and investigator sites to promote high level of quality and consistency across and within programs.

· Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborates with study team in development of risk mitigation strategies.

· Fosters Company’s Core Values and demonstrates Company’s Phenotype behaviors when collaborating with cross functional teams to advance quality activities while remaining independent and autonomous.

· Develops strategic risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies.

· Assess impact of audit finding and other identified compliance risks to subject safety, data integrity and business operations and escalates compliance risk to Director of GCP Operational QA.

· Manages and/or leads domestic and international audits for Clinical Investigators, to ensure compliance to ICH GCP, applicable regulations, and company standards.

· For assigned programs/ studies, leads quality issue investigations, root cause analysis and CAPA development and assist study teams in implementing corrective and preventive actions in support of sustainable compliance.

· Contributes to the development and implementation of continuous quality improvement initiatives.

· Engages with study teams and functions for proactive inspection readiness across assigned programs.

·Provides inspection support as necessary for Regulatory Agency inspections held at Company’s facilities or Clinical Investigator sites.

· May serve as GCP Quality Management System representative

– Participates in collaborative review of impacted SOP/WI

– Reviews and analyzes key Performance Indicator data and trends

– Analyzes risk and proposes remedial, corrective and /or preventive actions

– May participate on process improvement initiatives

· Participates in QA to QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed.

Minimum qualifications:

· M.S. (or equivalent degree) and 7+ years of relevant work experience, or B.S. and 10+ years of relevant GCP work experience

· Maintain contemporary knowledge and awareness of ICH GCP R2 and applicable global regulations and guidance for clinical development (e.g., FDA regulations, EU Regulations and Directives, MHRA Statutory Instruments, etc.)

· Experience with all phases of clinical trial development involving drugs, biologics, devices and drug/ device combinations.

· Working knowledge of Event Management processes and requirements, including investigation, root cause analysis, CAPA plan development and Effectiveness Checks.

· Ability to understand and translate customer needs for innovation and creative approaches to quality management

· Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers.

· Must be able to organize and prioritize work effectively to meet timelines with quality deliverables.

· Demonstrates proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines.

· Proficient in using Microsoft Office applications is an asset (MS Word, MS Excel, MS PowerPoint, Visio

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