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Vice President, Quality and Compliance

Remote, NC, USA | Science 37

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Quality Assurance
    Legal / Compliance
  • Experience:
    15-20 years
Job Description:
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Job Type



  • Full-time


Description


Position Overview


The Vice President of Quality and Compliance is a key member of the organization who assumes the leadership role in global quality and compliance matters.This position is responsible for all quality-related activities including quality assurance, quality control, and compliance.The VP, Quality and Compliance is expected to develop and successfully execute quality and compliance strategies to ensure corporate objectives are met within applicable regulations and guidelines while protecting patient safety and data integrity.


Duties and Responsibilities


Duties include but are not limited to:



  • Serve as a key and active member of the Global Management Team, interacting with team members to ensure objectives are aligned and that the company is performing to operational objectives.

  • Provides thought leadership to the entire organization on Quality- related standards, methods, and processes.

  • Responsible for all Quality-related activities including quality assurance, compliance, and M&A due-diligence and integration 

  • Responsible for ensuring company’s compliance with all regulatory agencies and all applicable standards worldwide

  • Representing the state of Quality in the organization to the Executive Team and Board through quarterly reviews and other communication

  • Sets strategic programs for implementing phase-appropriate quality standards and practices

  • Oversee preparations for all sponsor audits 

  • Oversees supplier qualification and audit and inspection readiness

  • Works in partnership with the head of Regulatory Affairs to advance regulatory acceptability of the emerging virtual clinical trial model, electronic consent and signatures, telemedicine assessments, and the technology required to support them

  • Counsel, train and interpret regulatory requirements to ensure company is in compliance at all times

  • Develop and maintain external relationships with regulatory authorities; contributes to regulatory guidance during public consultation periods

  • Develop and maintain systems, practices, and processes to ensure quality and compliance

  • Provide leadership and direction for significant deviation and CAPA events that may impact compliance status or incur significant business risk

  • Develop and successfully execute compliance strategies and implementation plans to ensure corporate objectives are met within applicable regulations and guidelines

  • Direct the development of systems, practices, and processes to ensure efficient and effective clinical trials including clinical trial management and data analysis, while ensuring all clinical studies operate to the highest ethical and safety standards

  • Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization

  • Provide leadership support, training and guidance to all company personnel with regards to quality and compliance

  • Oversees, manages and builds the Quality and Compliance team

  • Conducts performance reviews, calibration sessions, and feedback discussions with direct reports in a timely, frequent, and in a direct manner that is consistent with the company-wide keystone focus.

  • Builds an internal culture of innovative thinking that leads to the development and implementation of the company's mission and vision


Qualifications & Skills


Qualifications 



  • Bachelor’s Degree required

  • 15+ years of experience in quality, regulatory and compliance affairs 

  • In-depth knowledge of and experience with ICH-GCP, research-applicable CFRs (e.g., 21CFR312, 21CFR812, 21CFR11), and other global regulatory requirements

  • Proven track record of leadership and management of quality and compliance 

  • Extensive knowledge of regulations and compliance requirements 

  • Effective communicator: high level, written and oral communication skills; strong communication, negotiation and influence skills

  • Extensive management and team leadership experience; successful at managing people/projects

  • Strong leadership and execution skills; proven track record of delivering results and meeting targets


Skills/Competencies



  • Strong interpersonal skills, ability to communicate and manage well at all levels of the organization

  • High level of integrity and dependability with a strong sense of urgency and results-orientation

  • Ability to foster and cultivate business opportunities and partnerships 

  • Strong analytical skills and experience interpreting a strategic vision into an operational model

  • Communicates and exhibits leadership behavior consistent with the company-wide keystone focus 

  • Experience in building and guiding organizational teams. Leverages each team member's unique background and perspective to achieve team goals while providing clear direction and accountabilities. Commitment to collaboration, within and across departments

  • Understands interpersonal and group dynamics and reacts in an effective and tactful manner and has a range of interpersonal skills and approaches with ability to select a best-fit approach

  • Ability to motivate, influence and guide team members and direct reports; gains commitments from others


Capabilities 



  • Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed

  • Ability to communicate in English (both verbal and written)


Reporting



  • The position reports to the Chief Quality and Business Transformation Officer


Direct Reports



  • Director, Computer Quality Assurance

  • Director, Quality Assurance

  • Director, Clinical Quality Assurance

  • Director, Quality and Compliance


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