The Vice President, Global Quality will provide management and overall strategic direction and operational coordination of activities for global New Product Development Quality Assurance, Quality Engineering, Quality Operations, Regulatory Compliance, and Software Quality Assurance groups to ensure compliance with FDA QSR, ISO 13485:2016, and other applicable global regulatory requirements as well as alignment with company objectives and Quality Standards. The VP Quality will be a member of the senior management team and will report directly to Senior Vice President, Quality Regulatory and Clinical Affairs. The VP Quality will supervise a global organization encompassing multiple product development, manufacturing and product distribution/support sites worldwide.

ESSENTIAL JOB RESPONSIBILITIES:

• The VP Quality will be responsible for planning, organizing and directing global quality assurance and quality control functions. He/She will ensure that products made at all facilities and within manufacturing support services meet corporate and regulatory requirements. The company utilizes a variety of manufacturing processes and he/she should have a certain level of familiarity with: nucleic acid synthesis, enzyme expression and purification, lyophilization, injection molding, and microfluidics.
• The VP Global Quality will continually improve and synchronize the companylobal Quality Management System (QMS) on a global basis. This role assures that plant QS functions (e.g. QA, QC, QE, SQA) are appropriately organized and staffed. This includes developing and monitoring systems for product development, performance evaluation and distribution. The global VP Quality will interface directly with FDA, notified bodies, and other regulatory agencies on matters pertaining to manufacturing and distribution facilities, products, quality systems, and product performance
• The VP Global Quality will be responsible for evaluating and implementing continuous improvement processes to improve operational efficiency and effective global quality systems aligned with FDA and global regulatory requirements.
• The VP Global Quality will set the strategies for establishment of a global quality organization to support the product lifecycle management from concept to product realization followed by post market surveillance. This global quality leader role is to support the overall quality regulatory and clinical organization to meet the business growth, expansion and sustainability.

Qualifications

Required Knowledge - Skills - and Abilities:

• Bacheloregree required in a biology, chemistry, engineering or related field; Master or Ph.D. degree is preferred
• Twenty or more years of experience in regulated industry including In Vitro diagnostics and medical device quality operations, quality assurance, quality systems, and/or compliance role (less years of experience considered with advanced degree); experience with a molecular diagnostic company preferred;
• In addition to quality systems experience, experience in operations, manufacturing, and/or R&D preferred;
• Demonstrated ability to work as a senior leader and to engage the cross functional senior leadership team as needed.
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment.
• Demonstrated excellence in written and verbal communication.
• Demonstrated ability to work cross-culturally and to develop and maintain strong business partner relationships.
• Demonstrated ability to work effectively with US FDA and other regulatory agencies.
• Track record of measureable, operational improvements to Quality Systems related functions.

Knowledge and skills: * Substantial knowledge of QSR, GMP, FDA, ISO, and other medical device regulations.

• Extremely detail oriented with strong organizational skills, and high quality standards.
• Strong computer skills, including outstanding skills in grammar, punctuation, and spelling.
• Exceptionally strong team player with excellent interpersonal and communication skills.
• Experience working with end-users in coaching, mentoring and motivating capacities.

Preferred Qualifications:

• A proven track record as a successful and decisive leader in a strategic, multi-functional, matrixed and global environment.
• Management of complex projects with ambitious milestones in high pressure circumstances.
• Understanding of P&L management with strong financial and analytical skills.
• Strong team building skills to ensure cross functional effectiveness, strategy development, high level of department contributions, and overall strong performing team.
• Clinical laboratory experience, including hands-on experience running PCR-based research or clinical assays.
• LEAN or Six Sigma operational excellence training or certification.