The Vice President of Global Quality will provide quality direction for US (Milford, Taunton, Colorado, Pittsburgh), European (Wilmslow & Wexford), Asia (Singapore) and other global business sites. They will lead a worldwide organization of 140+ QA professionals that support R&D and manufacturing operations within a matrixed Class I-II, IVD/IVDR, biotechnology instrumentation, and software product development environment.
The individual will be responsible for the development, implementation, maintenance and overall success of the company’s quality programs and strategy; including articulating quality standards and objectives, developing methods to embed quality into the product development and manufacturing process, establishing vendor relationships and quality standards and developing and implementing innovative programs to focus employees onimproving product quality.
By working closely with the company leaders and cross functional teams, this position will set the examples for driving and implementing the culture of quality. This position will also provide the overall leadership, continuous improvement, and direction to the global sites in the company.
- Provide Quality direction for European (Wilmslow & Wexford), US (Milford, Taunton, Colorado, Pittsburgh), Asia (Singapore) and other business sites.
- Lead a worldwide organization of 140+ QA professionals that support R&D and manufacturing operations within a matrixed Class I-II, IVD/IVDR, biotechnology instrumentation, and software product development environment.
- Work closely with TA Instruments business units and Consumables business (ASR, ERA) to drive overall global quality strategy, and setting goals and objectives.
- Directs the global quality organization representing multiple locations with Sr. Directors and Directors whose responsibilities are regionally based.
- Lead a team of the following disciplines; Design QA, Engineering QA, Quality Management System, Quality Project Management, Quality Shared Services, Informatics Quality, and Operations Quality.
- Reporting to the SVP, Global Operations, this position will serve as an advisor, a consultant, and a subject matter expert to the executive team providing guidance and expertise in areas related toquality, compliance, regulations, etc. and is responsible for setting strategic direction for the company’s quality policies and procedures.
- Responsible for driving effective and efficient Quality Management System including driving harmonization and standardization, while ensuring QMS is established well with appropriate business processes in the company.
- Oversees the performance of internal and external audits.
- Responsible for Quality long-term strategy in coordination with leadership and in-line with overall company-wide strategy.
- Oversees the development of employees, talent, process, and technology necessary to reach annual and long-term objectives.
- Responsible for managing assigned budgets.
- Performs other duties as assigned.
- Minimum of a Bachelor’s degree is required in a science or engineering area.
- Advanced degree is a plus (PhD, M.S. in a Life Science or MBA) as well as any professional certifications (i.e. RAC, Six Sigma, ASQ certifications).
- Minimum of 15 years of experience in leading Quality Assurance/Quality Engineering within the medical device, biotechnology, or similar life sciences arena.
- Experience with Class I and II medical devices/systems and in vitro diagnostics experience highlydesirable. Class III medical device experience is a plus.
- Prior experience in a senior leadership role with overall responsibility for directing a Quality organization and setting strategic direction for the company's quality policies and procedures is required.
- Strong understanding and ability to critically review Quality Systems, Engineering and Compliance.
- Have a strong understanding of quality requirements successfully implementing cGMP/QSR, ISO 9001/13485, FDA, six sigma and lean manufacturing programs.
- Ability to identify and analyze complex problems and recommend actions.
- Able to work effectively in a complex, matrix work environment.
- Exceptional team building skills and demonstrated ability to direct activities from concept through tocompletion.
- High energy problem solver/achiever – Self Starter.
- Well-organized, detail-oriented and outstanding work ethic.
- Strong team orientation and team builder.
- Ability to mentor and development members of the Quality team.
- Able to travel domestically and internationally.