VP OF QUALITY SYSTEMS (GLOBAL PHARMA/MED DEVICE ORGANIZATION)

VP OF QUALITY SYSTEMS (GLOBAL PHARMA/MED DEVICE ORGANIZATION)

This role is HIGHLY VISIBLE and is critical to my clients continued success/growth. 

Do you have experience defining and implementing a world-class quality system for a Global Med Device or Pharma organization?  If so, please read on:

Our client, a leader in the Medical Device/ Pharmaceutical industry and in applying the principles of biotechnology to medical devices has built a fully integrated medical device company with thousands of products for a number of medical specialties.  They are experiencing significant growth and are in search of a senior level Quality Assurance/Systems professional to join their team.

SUMMARY DESCRIPTION

Responsible for directing and managing Quality System, Quality Assurance and regulatory compliance programs.  This position plays a leadership role in defining the Quality System strategy for the Global organization.

Responsible for all quality operations and management in North America and Europe.

RESPONSIBILITIES

• The primary responsibility of the Vice President Quality System is to ensure that the division is in compliance with all national and international governmental quality system regulations.
• The Vice President of Quality Systems ensures that general umbrella quality systems, processes, and practices exist for the entire division, and the specific systems, processes and practices exist for all individual plants and facilities in the division. That such systems are developed, established, implemented and maintained in compliance with all applicable FDA Quality System Regulations, ISO 9001, ISO 13485:2003, Canadian Medical Device Conformity Assessment System (CMDCAS), Medical Device Directives (93/42EEC), Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Device, Regulation) and other national and international guidelines.
• The Vice President of Quality Systems has overall responsibility for the Quality Assurance and Quality Control Departments of Global Operations plants and facilities and is also responsible for the division’s objective strategic planning, direction and leadership for all Quality Assurance Programs and Processes.
• S/he is responsible for managing the on-going Quality System program to ensure that the division is complying with FDA Quality System (Good Manufacturing Practices – GMP) and international regulations for medical devices and assess opportunities for program improvement.
• Demonstrate a proactive approach to Quality Systems.  Identify, review and anticipate emerging issues likely to impact the division and monitor this evolution.  Develop strategies for influencing the outcome of key issues and recommend appropriate actions to the other members of his management team.
• Strategic planning, direction and leadership for Quality System activities including research, registration, and compliance with governmental regulations for new device research and development, marketing and environmental matters.
• Responsible for managing the department of Quality Systems in a manner consistent with policies and procedures.  These would include:  salary administration, budget and financial controls, administration of all programs, policies and procedures.
• Provide Quality Systems feedback in the design, review and approval of labels for all investigational and marketed products.
• Develop, coordinate and implement documentation and maintain systems, procedures and documentation that will assure compliance and minimize negative regulatory actions in the areas of Quality System (GMP) and Good Laboratory Practice (GLP) compliance.
• Provide Executive Management with strategic Quality System evaluations of new acquisitions.
• Work with the Management Team of all sites in defining divisional level strategies, actions and responses to Quality System issues or problems.
• Provide to the Management Team strategic and tactical Quality System inputs relative to anticipated or pending actions by regulatory agencies (recall, regulatory letters, notices of noncompliance, etc.).  Effectively participate in the decision-making process and coordinate the implementation of the company response.
• Provide to the Management Team – strategic and tactical Quality System inputs relative to actions and response for proposed regulations (new), recommendations for compliance, assessment of risk and implementation plans for compliance.
• Performs all other related duties as required.

DESIRED MINIMUM QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.  Any equivalent combination of education and experience that provides the applicant with the knowledge, skills and abilities to perform this job is acceptable.

• Ph.D. with 8 to 10 years experience, Masters Degree with 10 to 15 years experience or Bachelor Degree with 15+ years experience
• Proven ability to manage, train, and motivate a team of quality assurance/quality control professionals with budgetary responsibility
• Exceptional writing and interpersonal relationship skills;
  Experience in effectively leading an international healthcare manufacturing quality organization
• Demonstrated ability to take a quality organization to the next level in terms of processes, operations and culture.
• Extensive experience with direct contact with FDA and other international regulatory bodies;
• Proven track record of experience in Quality System Regulatory compliance.  Knowledge of FDA regulations, ISO 9001, ISO 13485:2003, CMDCAS, Medical Device Directive Regulation (93/42EEC), Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Device, Regulation) and other national and international regulations.

COMPENSATION

200K base salary, (Compensation commensurate with experience and salary history), annual target bonus and complete benefits package.
            
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