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Executive Director, Quality Compliance and Audit

Reference Number: 2816
Location: MA

Our client is a rapidly growing, specialty biopharmaceutical company.  They have asked us to assist them in their search for an Executive Director, Quality Compliance and Audit.

The Executive Director, Quality Compliance and Audit provides leadership to the Company for the design and operation of appropriate quality systems and activities to ensure full conformance with applicable GMP, GCP and GLP regulations. The incumbent will support annual operational goals related to the quality systems associated with both drug development and commercial products.  He/she will establish comprehensive quality and compliance programs with applicability to all Company sites and contract vendors to ensure compliance with global regulatory requirements. The incumbent will keep current with ICH and global regulatory agency requirements and industry best practices and ensure that Company systems stay current.  This position provides leadership to the Company in proactively monitoring for, identifying and correcting significant GxP compliance issues.  He/she will develop and oversee comprehensive audit processes to ensure the integrity of quality systems and to identify deficiencies requiring corrective actions.

Major tasks and responsibilities will include:

  • Develops, directs and maintains a comprehensive, annual strategic quality plan for ensuring Company compliance with regulatory requirements for GMP, GCP and GLP activities.
  • Provides strategic guidance and consultation to executive management, business process owners, and outside services vendors for the implementation of quality systems based on Company standards and policies.
  • Directs the activities of the GMP Audit Unit, Research QA Unit and the Quality Engineering Unit.
  • Directs this staff and help direct DSP staff assigned to the Global Quality Audit and Compliance Department and the Global Quality Operations and Planning Department.
  • Leads Company quality initiatives to ensure GMP, GCP and GLP compliance with applicable worldwide regulatory agency requirements.
  • Ensures the development of operational guidelines, compliance standards, standard operating procedures, test and inspection methods and other quality systems guidelines to ensure full compliance with global regulatory requirements.
  • Provides comprehensive support to the Company for the development and implementation of a fully integrated Global Quality System.
  • Develops and directs processes for local and international audits using globally harmonized processes.
  • Directs the development of global compliance standards and SOPs.
  • Directs the development of appropriate CAPA plans to both correct and prevent GxP deficiencies and ensure that these plans are globally harmonized.
  • Develops and directs projects that drive continuous improvement.
  • Provides consultation and leadership to business process owners for implementation of quality improvement projects.
  • Conducts and directs the conduct of GMP, GCP and GLP audits of CMOs, CROs, clinical sites, testing laboratories and services vendors.
  • Develops and implements corrective action plans and conduct compliance trending.
  • Coordinates, monitors and reviews audits conducted by other Company quality units, to assure that applicable compliance and audit standards are followed and to help develop appropriate corrective and preventive action plans.
  • Conducts and directs the conduct of internal systems audits and develop appropriate corrective and preventive action plans.
  • Elevates critical and significant quality assurance and compliance issues to executive management and provides consultation for mitigation and corrective actions.
  • Directs the document administration and archival function for regulated documents involving QCA GMP, GCP and GLP activities.
  • Reviews and approves all SOPs and related documents for GMP, GCP and GLP activities.
  • Provides periodic assessments to senior management on the compliance and operational status of internal and external systems via formal Management Review meetings and periodic reports.
  • Identifies and assesses compliance risks and exposures, and devises overall strategies for risk mitigation.
  • Maintains the official GMP document archive for domestic or international regulatory agencies to review.
  • Establishes standards for inter-company Quality Agreements and review agreements as needed to ensure conformance and effective execution.
  • Establishes and oversees inspection readiness requirements reviews for Company facilities, new vendors, products, and processes, on a global basis.
  • Manages the GMP, GCP and GLP training program for the Company including archiving of training records.
  • Provides GMP, GCP and GLP consultation to the Global Clinical Development Division and to project teams.
  • Monitors for changes to rules, regulations, guidance documents and industry trends both domestically and internationally and updates the strategic plan accordingly.
  • Manages and supports FDA and international agency regulatory agency inspections of Company facilities and ensures prompt development of corrective action plans.
  • Conducts due diligence activities for quality/compliance areas for external business opportunities.
  • Serves in a leadership capacity for internal Quality System Governance Committees.

We seek candidates with the following qualifications:

  • Minimum of Bachelor’s degree in a scientific discipline (e.g. biology, chemistry, pharmacy) or relevant field of study; or equivalent combination of training and experience in a regulated industry.
  • Must have a minimum of 15 years of experience in an FDA–regulated biotechnology, pharmaceutical, or medical device company.
  • Must have a minimum of 10 years of supervisory experience.
  • Must have experience managing domestic and international regulatory agency inspections, regulatory compliance, and quality systems implementation.
  • Must be a hands-on technical professional with a comprehensive knowledge of current quality standards and applicable federal and international regulations and policies.
  • Must have an expert understanding of current FDA regulations, and pharmaceutical industry quality standards as well as international expectations for quality systems.
  • Must be able to investigate and resolve complex technical and compliance issues, and make/evaluate proposals for solutions.
  • 35% (on average) travel required.
  • Must be able to exercise appropriate judgment as necessary.
  • Requires a high level of initiative and independence.
  • Excellent written and oral communication skills required.
  • Requires ability to use a personal computer for extended periods of time.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2816. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.