Job ID R-405103 Date posted 08/10/2021 Apply

Director Clinical Quality & Compliance

Job Description Summary

The Director Clinical Quality and Compliance, will provide expertise and guidance regarding regulatory requirements, GCP guidelines and BD Standard Operating Procedures (SOPs) for the conduct of clinical studies.
As an expert, the Clinical Quality and Compliance Lead (CQC) will utilize a risk-based strategy to prioritize CQC support activities for clinical trial activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition the CQC lead will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.



This position serves as an important conduit to the broader Medical Affairs organization to ensure a culture of quality and compliance. Incumbent will leverage his/her Clinical compliance expertise coupled with a comprehensive understanding of the MedTech landscape to proactively contribute to the Global Clinical Affairs team within BD.



This role will communicate and interface with internal cross-functional partners, identifying areas for improvement and ensuring compliance with current regulatory policy, legislation, and guidance. The CQC lead will actively contribute to the development and implementation of Policy/Standard Operating Process / Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for clinical trial execution



The CQC lead is expected to foster an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions.

Job Description

JOB SUMMARY:

The Director Clinical Quality and Compliance, will provide expertise and guidance regarding regulatory requirements, GCP guidelines and BD Standard Operating Procedures (SOPs) for the conduct of clinical studies.
As an expert, the Clinical Quality and Compliance Lead (CQC) will utilize a risk-based strategy to prioritize CQC support activities for clinical trial activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. In addition the CQC lead will partner with Quality, Regulatory, Safety and other key functions to enable transparency and escalation of quality and compliance matters.

This position serves as an important conduit to the broader Medical Affairs organization to ensure a culture of quality and compliance. Incumbent will leverage his/her Clinical compliance expertise coupled with a comprehensive understanding of the MedTech landscape to proactively contribute to the Global Clinical Affairs team within BD.

This role will communicate and interface with internal cross-functional partners, identifying areas for improvement and ensuring compliance with current regulatory policy, legislation, and guidance. The CQC lead will actively contribute to the development and implementation of Policy/Standard Operating Process / Procedures in addition to tools, and templates deemed controlled in supporting regulatory requirements for clinical trial execution

The CQC lead is expected to foster an open and collaborative environment across the global site network and will ensure implementation of Global Quality (GCP/GVP/ICH), Legal and Healthcare Compliance strategies within assigned functions.

KEY RESPONSIBILITIES:

  • Provide quality leadership and direction GCA stakeholders on GCP related activities/issues and act as GCP expert/consultant for CQC colleagues.
  • Act as CQC member of clinical study teams for relevant Therapeutic Areas.
  • Develop strong relationships with associates across functions and teams providing coaching and compliance guidance as needed.
  • Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity in order to identify: priority studies, compliance metrics for tracking, high-risk vendors, and key CQC activities (i. e. protocol review, vendor evaluations, inspection readiness).
  • Identify and escalate significant compliance issues to CQC team and relevant leadership, including the assessment of serious breaches.
  • Participate as member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
  • Establish relationship with CRO Quality Team member for the ongoing review of quality and compliance issues.
  • Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
  • Support GCA clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
  • Provide support and guidance for GCA Quality Management System activities including self-reporting deviations, root cause analysis and Corrective Action/Preventative Action plan development and evaluation.
  • Present GCP training to MA functions based on identified needs.
  • Facilitate the presentation and interpretation of audit and inspection metrics.
  • Identify and anticipate trends in quality issues and collaborate with GCA teams to ensure risk-managed solutions are implemented in a timely fashion
  • Maintain high level of expertise in international GCP regulations and internal Policies and Procedure that may impact drug development.
  • Promote cross-functional communications and alignment with other GCP and Healthcare Compliance partners within the organization.
  • Provide regular updates to Medical Affairs Leadership and participate in the resolution of quality issues.
  • Liaise with respective training functions to assess job role training requirements and participate in the development and execution of GCP, SOP or Policy related training (as required)
  • Provide support and guidance during and following internal audits and external regulatory inspections (as required)
  • Support investigations and corrective action plans for appropriate discrepancies as it relates to GCA and /or direct the internal investigation of compliance issues as required, collaborating with relevant Compliance Partner(s)
  • Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations and tools intended for use in clinical trial conduct
  • Supports GCA and Medical Affairs Inspection Readiness program and make recommendations for its continuous improvement
  • Serve as an advisor to management, as needed, and act as an internal/external spokesperson for the organization on matters pertaining to policies, quality plans, objectives and business goals
  • Work collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and provide input on any unique business requirements.
  • Lead or participate on quality and compliance initiatives, as assigned

QUALIFICATIONS:

  • Bachelor’s Degree required, preferably in the life sciences, advanced degree preferred
  • Minimum ten years’ experience working within a regulated industry, verifying compliance to global regulations 
  • Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools
  • Advanced knowledge of and experience with MedTech regulations, and relevant standards (e.g., FDA, ISO, MDR, IVDR GDPR)
  • Knowledge of and experience with O-US country related regulations
  • Quality assurance medical device and/or pharmaceutical experience, with significant device experience in clinical research is required
  • Experience in Regulatory Affairs and/or Quality department, preferred
  • Certified auditor is preferred 
  • Clinical Operations experience a plus
  • ASQ certification, IRCA or other relevant auditor certification a plus

PERSONAL CHARACTERISTICS:

  • Effective communication skills both verbal and written
  • Ability to work independently with minimal supervision and accountable for managing multiple program objectives  concurrently
  • Demonstrated leadership competencies
  • Establishes rapport and collaborates with other (internal and external) partners; builds constructive and effective relationships
  • Anticipates problems, issues, and risks; proactively looks to minimize the impact of identified compliance issues
  • Multi-disciplinary knowledge across functional areas

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

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