Associate Director, Clinical Quality Compliance Expert

4 weeks ago

Boston, Massachusetts, United States BioSpace, Inc. Full time
Job Description

Job Title: Associate Director, Clinical Quality Compliance

Company: BioSpace, Inc.

Job Type: Full-time

About Us: At BioSpace, Inc., we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Job Summary

We are seeking an experienced Associate Director, Clinical Quality Compliance to join our team. The successful candidate will provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.

Key Responsibilities
  • Provide quality oversight to the clinical trial delivery quality systems, promoting operational and compliance excellence, quality risk management, and knowledge management.
  • Maintain a state of control by implementing monitoring and control systems that ensure the quality systems supporting the clinical trial delivery are aligned with applicable regulations.
  • Report to and act as a strategic expert to the Head of GCP Quality Compliance in developing GCP Compliance strategies, managing the operational activities of, and building capabilities within the GCP Compliance function, and ensuring agreement on the CPMQ vision.
  • Partner with different functions that contribute to the clinical trial delivery in identifying systemic quality and compliance risks, conducting investigations, and developing adequate corrective and preventive actions (CAPAs), managing changes, and facilitating improvement that is in consideration of Takeda's values and priorities.
  • Lead the clinical trial delivery system inspection readiness program, including the implementation of a strategy. Engage with relevant responsibilities and partners to ensure inspection readiness, driving accountability and transparency.
  • Function includes Global Development Office, Data Science Institute, Global Regulatory Affairs, Procurement, Legal.
  • Provide insights to the latest requirements, operational and compliance metrics, and storyboards, identify quality and compliance inspection risks, and provide tactical directions in the mitigation.
  • Host GCP inspections and provide strategic direction to relevant responsibilities and Subject Matter Experts (SME).
  • Ensure a communication plan is in place, enabling knowledge sharing of insights and risks. Communicate the progress of inspections daily, summarizing the inspection activities and potential observations and mitigation activities. And timely escalate to management.
  • Lead the inspection response activities, ensuring the responses are adequate, reviewed, and approved internally by the relevant partners, at the right levels, and submitted on time.
  • Oversee the completion and closure of inspection CAPAs, ensuring that no inspection CAPAs are late. Mitigate and escalate any risks. Ensure appropriate effectiveness checks are developed for relevant inspection CAPAs.
  • Be a 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 non-GCP specific inspections (e.g., lead complex quality investigations improving the clinical trial delivery systems).
  • Provide Quality Leadership for other quality investigations, ensuring the right partners are engaged in impact assessment, root cause analysis, and CAPA development.
  • Develop lessons learned from on regulatory inspections and quality investigations. Promote knowledge management.
  • Lead improvements projects that ensure a compliant quality system in the clinical trial delivery quality systems.
  • Approve controlled procedures related to clinical trial delivery quality systems to ensure regulatory and past inspection commitments are considered.
  • Escalate issues of potentially critical non-compliance and lack of urgency in remediation to senior management.
  • Analyze results, quality issues, and investigations to identify applicable trends and to promote a state of compliance.
  • Develop and monitor relevant metrics and Main Performance/Quality Indicators (KPI/KQI). Mitigate, communicate, and escalate any risks flagged by the metrics/KQIs, ensuring actions are commensurate to the risk and timely.
  • Drive the development and execute the strategy to understand the health of the clinical trial delivery quality system (i.e., risk register, KPIs).
  • Contribute to any relevant quality and compliance governance in Takeda, including the Clinical & Safety Quality Council, communicating any quality or compliance risks and opportunities, continual improvements, and successes.
Requirements
  • BSc in a scientific or allied health/medical field (or equivalent degree).
  • Minimum of 10 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 5 years of experience in GCP Quality/Compliance.
  • Experience with pharmaceutical development, medical affairs, and GCP/GVP regulations, including FDA, EU, MHRA, PMDA, and ICH.
  • Experience must include successful implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, and remediation activities on a global level.
  • Experience managing complex organizational compliance issues and in implementing organization-wide compliance projects.
What We Offer

At BioSpace, Inc., we offer a competitive salary and benefits package, including medical, dental, vision insurance, a 401(k) plan, and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

We are proud of our commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state, and local laws, and any other characteristic protected by law.

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