Position Overview

The Quality System Compliance Lead will have quality oversight over development, manufacturing, and other enabling processes for In Vitro Diagnostics (IVD) products and will be responsible for all internal audits and external audit or inspection readiness for the HP200A organization.  This position is a unique opportunity to develop the quality processes and infrastructure required to deliver IVD products to the international market, so that development and manufacturing requirements are met for new and existing products, including but not limited to Standard Operating Procedures, Work Instructions, Global Audit Plans, and External Audit Strategy. This individual is responsible for providing technical expertise, and teaching and coaching others on IVD and MD quality requirements.

Key Responsibilities

• Assure that the company has policies, processes and procedures in place so that internal audits and external audits are conducted and documented effectively and efficiently.

• Plans, schedules, manages, conducts, and reports on internal audits of company and site processes and records to ensure compliance with applicable quality and regulatory standards.

• Train, Coach, and Develop a pool of internal auditors from throughout the company to deliver to the global audit plan. Act as a lead auditor.

• Acts as an agent of change and continual improvement through audit conduct, and delivery of objective and impact driven audit observations.

• Lead external audit readiness activities to ensure preparedness for inspections by regulators and/or notified bodies. Develops roles, workflows, and training for audit participants and support personnel.  

• Performs regulatory intelligence activities to provide organizational foresight on changing regulations and inspection trends. Applies regulatory intelligence in audit plans and sampling strategies.

• Performs compliance and/or gap assessments to regulations or standards for the purposes of planning improvement initiatives or change projects.

• Works closely with the Technical, Engineering, and Research & Development, Manufacturing, and other functions in order to ensure objectives are met in areas of responsibility.

• Defines and implements Quality System documentation, including procedures, work instructions,  nonconformances, CAPA and associated investigations for areas of responsibility.

• Participates in project work and initiatives associated with Quality System issues in conformance to regulatory requirements. Interfaces and provides Compliance guidance or training to functions. Participates in the design and implementation of Quality improvement activities.

• Maintain the metrics required to monitor the compliance of the internal audit program and escalates issues when necessary.

• Implement an electronic quality management system

• Support supplier audits as needed

• Help to drive management review

• Other tasks as required by the business.

Required Knowledge/Skills, Education, and Experience

BS/BA in related discipline, or advanced degree, where required, or equivalent combination of education and experience. Certification as an Auditor is required. A degree in a technical discipline ensures a basic understanding of the chemistry and principles of the products that are manufactured at the site.

Demonstrates and applies a broad knowledge of field of specialization through successful completion of moderately complex assignments. Successfully applies complex knowledge of fundamental concepts, practices, and procedures of particular area of specialization. Demonstrates knowledge of organization's business practices and issues.

Prior successful demonstration of:

• Leading an internal audit program (5+ years) for regulations and standards affecting in-vitro diagnostics (IVD) and medical devices (MD), such as FDA QS Regulations Part 820 & Part 11, ISO13485, ISO14971 and cGMP required for maintaining validation and design control compliance.

• Quality Management (5+ years) required to understand and promote Quality standards.

• Project Management (3+ years) required to manage group activities.

• The ability to work effectively across a matrixed organizational structure and be a team player is a key requirement. Agile and flexible team player.

• Able to effectively manage short term and long-term deadlines.

• The incumbent needs to have excellent written, negotiation and oral communication skills. Excellent working knowledge of English grammar and punctuation.

• The incumbent needs to be receptive to change and be able to drive change.

• Auditor certification required; any additional certification in the area of cGMP, Quality management, and/or design/validation is highly desirable.

• Experience with Molecular Diagnostics is highly desirable.

• Travel up to 25% may be required post COVID-19

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