Vice President, Quality Assurance

About the company:

My client is a 15-year-old publicly traded biomedical company that focuses on women's health. They have developed a suite of novel minimally invasive reproductive health products with four products on the market, and one more in late-stage development, they have developed a disruptive technology that is the only known alternative for a procedure that is currently being performed over 700K times a year.

Located in a highly desirable Southeastern US location, they are seeking a Vice President of Quality to join their executive leadership team. Reporting to the COO, you will have a seat at the leadership table and a strong voice and impact in the development and implementation of organizational goals and objectives, as well as strategic plans that support the company's future growth.

Position Summary

Provides overall direction and guidance of all quality assurance principles and techniques in the planning, development, and implementation of quality system processes and procedures to support the various functions of the organization, specifically R&D, Clinical and Manufacturing. Participate in the development of company-wide processes and systems that result in the effective execution of the Company's business strategy.

Specific Job Functions

• Participate as a member of executive management in the development and implementation of organizational goals and objectives, as well as strategic plans that support the Company's overall strategy for future growth.
• Oversee day to day operations and provide strategic/ operational direction for the Company's Quality Assurance department.
• Implement programs, policies, improved processes, and management methods to ensure optimization of quality systems and attainment of business plan objectives. Instill a culture focused on quality and continuous improvement.
• Responsible for developing operational plans that are strategically focused on key areas and projects critical to the Company's success.
• Establish objectives and assignments to subordinate managers involved in developing, modifying, and executing company policies, which effect immediate operations.
• Identify department staffing needs, train new department personnel and provide mentoring/ guidance to staff to ensure adherence to professional standards, SOPs, and overall corporate objectives.
• Collaborate with other executive management to develop and implement plans for the infrastructure of systems, processes and personnel designed to accommodate rapid growth objectives.
  • Prepare and manage department budgets, operational procedures, policies, and protocols.
  • Ensure workplace is conducive to productive and safe work environment and compliant with appropriate federal and state regulatory requirements.
  • Management Representative with the authority and responsibility for ensuring the quality system requirements are effectively established, implemented and maintained; reporting on the performance of the quality system, and any need for improvement, to executive management; and ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
• Jointly responsible with the head of Regulatory Affairs to serve as PRRC (person responsible for regulatory compliance) as defined in the European Medical Device Regulation 2017/745.
• Develop and implement effective internal quality policies and procedures consistent with Company objectives, customer needs, and FDA QSR/ cGMPs, ISO 13485 regulations, and CE marking guidelines.
• Analyze, develop, implement, and audit policies and procedures for applicability and compliance to regulations.
• Responsible for company-wide quality system procedures for executing how the company handles process validation, process control and enhancements, quality metric reporting, supplier qualification, design assurance programs, complaint handling and CAPA programs.
• Responsible for quality control daily operations to include: final product testing and release, receiving and in-process testing, stability testing, QC inspections and audits, and QC documentation.
• Manage material control program to include: QC materials management including labeling and storage, QC materials inventory and use and materials lot control.
• Develop and implement company-wide training programs for new and current employees on FDA QSR/ cGMP's, ISO 13485 regulations, and CE marking guidelines.
• Support engineering in the development, testing, verification, validation and commercialization of new products, or changes to existing products to assure products conform to government and Company standards and satisfies all applicable regulations.
• Support engineering in the qualification and validation of equipment and processes.
• Develop, coordinate, and administer internal and third-party quality audits, inclusive of schedules, communication, reports, and tracking follow-up actions.
• Interface with the FDA, ISO, CE, and other international regulatory agents regarding on-site quality system inspections and surveillance audits. Respond to regulatory and/or third-party audit observations.
• Develop and implement instructions/methods for inspecting, testing, and evaluating product conformance to specification.
• Process non-conforming material reports including MRB dispositioning. Work with suppliers to correct problems.
• Maintain the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
• Support manufacturing in the investigation of manufacturing problems and product complaints to determine the root cause and recommend appropriate corrective and preventive action to avoid recurrence. Lead and perform component/ product testing.
• Responsible for the deployment, validation, and maintenance of the electronic Quality Management System (eQMS) software.
• Maintain the product stability program, including both real time and accelerating aging.
• Evaluate quality data, prepare periodic reports to monitor trends, and report to management to ensure the Company's continuous improvement efforts are on track.
• Review and approve reports and other documentation prepared by QA and QC for regulatory submissions/inspections.
• Act as primary quality team member for projects and product teams, providing counsel, training, and interpretation of FDA and other applicable regulations to Company personnel.
• Participate in risk analysis to identify appropriate protective measures to mitigate risk associated with identified hazards.

  Minimum Qualifications, Education & Work Experience

• Bachelor's degree required with 20 years' experience in Quality Assurance, Quality Engineering or related functions in a medical device or FDA regulated company. Prefer degree in Engineering, Science or related field. ASQ, CQM (Certified Quality Manager) or CQE (Certified Quality Engineer) is highly desirable.
• Strong working knowledge of FDA Quality System Regulation 21 CFR Part 820 (cGMP/ QSR) and related parts, 21 CFR Part 58 (GLPs), ISO 13485, MDSAP, 93/42/EEC (EU Medical Device Directive), MEDDEV 2.12 (Medical Device Vigilance Guideline), and EU MDR (2017/745).
• Experience in strategic planning, formulation of policies and implementation of company objectives.
• Must have the ability to work with internal and external contract partners to resolve technical issues and meet project timelines.
• Proven success in selecting and retaining employees, capable of managing in a dynamic, rapidly scaling work environment, ability to maintain effective working relationships.
• Ability to establish and meet department priorities, deadlines and objectives.
• Demonstrated leadership in creating, supporting and contributing to the culture of the company, celebrating the value of each individual as a part of a greater team.
• An entrepreneur with a roll-up your sleeves attitude expressed by directly executing day-to-day activities necessary in an early stage, high-growth company.
• Excellent planning/logistical skills with the ability to effectively direct the Company's quality assurance operations to meet strategic objectives with respect to regulatory compliance, and annual and long-term budgets.
• Must be a positive, self-confident, decisive leader who has excellent communication skills in both oral and written formats, as well as excellent listening skills with a proven ability to solve problems.
• Absolutely ethical with image and style that generates respect and credibility.
• Be a team-oriented and goal-oriented individual with the maturity to succeed in a business environment.
• Understanding of statistics required - Cp, Cpk, AQL, etc.

Preferred Qualifications, Education & Work Experience

• Class III Medical Device experience.