GCP Quality Compliance Lead

Job Title: GCP Quality Compliance Lead

Location: Cambridge, MA (onsite 2 days/week)

Experience: 10+ Years

Interview Mode: Virtual

Job Description:

Must Have:

· Strong experience holding the responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.

· Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.

· Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.

OBJECTIVES/PURPOSE:

· Provides quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management and knowledge management.

· Maintains a state of control by implementing effective monitoring and control systems that ensures the quality systems supporting the clinical trial delivery is robust and aligned with applicable regulations.

· Partners with the different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting robust investigations and developing adequate corrective and preventive actions (CAPAs), managing changes and facilitating continual improvement that is aligned to the company's values and strategic priorities.

· Reports to and acts as a strategic thought partner to the Head of GCP Quality Compliance in developing and implementing GCP Compliance strategies, in managing the operational activities of and building capabilities within the GCP Compliance function and in ensuring alignment with the CPMQ vision.

ACCOUNTABILITIES:

· Leads the clinical trial delivery system inspection readiness program, including the development and implementation of a strategic plan. Engages with relevant functions and stakeholders to ensure inspection readiness, driving accountability and transparency. Functions include, but not limited to, Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal, etc.

· Provides insights to emerging regulations and requirements, operational and compliance metrics and storyboards, identifies quality and compliance inspection risks, and proactively pro-vides strategic and tactical directions in the mitigation.

· Hosts GCP inspections, and provides strategic direction to relevant functions and Subject Matter Experts (SME).

· Ensures a robust communication plan is in place, that enables knowledge sharing of insights and risks. Communicates the progress of inspections on a daily basis, summarizing succinctly the inspection activities and potential observations and mitigation activities. Effectively and timely escalates to management.

· Leads and manages the inspection response activities, ensuring the responses are adequate, reviewed and approved internally by the relevant stakeholders, at the right levels and submitted on time. Reviews and provides input to response to ensure the impact is thoroughly assessed, appropriate root cause is identified, and specific, measurable, achievable, relevant and time-bound CAPAs are developed.

· Oversees the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigates and escalates any risks. Ensures appropriate effectiveness checks are developed for relevant inspection CAPAs. Provides input to the effectiveness check plans, and reviews and approves outcome.

· Acts as Subject Matter Expert (SME) on the Clinical Quality Compliance activities including deviation management, quality investigation, corrective and preventive actions (CAPA) management and oversight and change control. Represent Clinical Quality Compliance in these topics in inspections.

· Support and provide relevant guidance to other other non-GCP specific inspections (e.g., GVP, GMP, etc).

· Leads complex quality investigations impacting the clinical trial delivery systems. Provide Quali-ty Leadership for other quality investigations ensuring the right stakeholders are engaged in impact assessment, root cause analysis and CAPA development.

· Develop lessons learned from on regulatory inspections, and quality investigations. Promotes knowledge management.

· Leads cross-functional continual improvements projects that enable a compliant quality system in the clinical trial delivery quality systems.

· Review and approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.

· Escalates issues of potentially critical non-compliance and/or lack of urgency in remediation to senior management. Analyzes results, quality issues and investigation to identify actionable trends and to promote a state of compliance.

· Develops and monitors relevant metrics and Key Performance/Quality Indicators (KPI/KQI). Mitigates, communicates, and escalates any risks flagged by the metrics and KPIs/KQIs, ensuring actions are commensurate to the risk and timely. Drives the development and executes the strategy to understand the health of the clinical trial delivery quality system (i.e., risk register, KPIs).

· Contributes to any relevant quality and compliance governance in the organization, including the and the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements and successes.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

· BSc in a scientific or allied health/medical field (or equivalent degree).

· Minimum of 7 years of increasing responsibility and relevant experience in the global pharmaceutical industry in functions such as Clinical Operations, Data Management and Statistics, with at least 3 years of experience in GCP Quality/Compliance.

· Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA, EU, MHRA, PMDA and ICH.

· Experience must include successful development and implementation of a clinical or pharma-covigilance audit program, hosting/leading regulatory inspections and remediation activities on a global level.

· Experience in managing complex organizational compliance issues and in identifying and implementing organization-wide compliance initiatives.

· Skilled in managing global, cross-functional projects.

· Fluency in written and spoken English, additional language skills a plus.

Job Types: Full-time, Contract

Work Location: In person