Our client is dedicated to advancing the impact of genomics in healthcare and precision medicine. Their highly sensitive and cost-effective mass spectrometry-based platform, the MassARRAY® System, is used globally in diverse research fields such as cancer profiling for solid tumors and liquid biopsies, inherited genetic disease testing, pharmacogenetics and clinical research.

Their mission is to equip genomic and clinical testing laboratories with practical solutions that increase productivity and decrease time to results. Whether assessing sample quality, screening samples for actionable mutations, or enabling routine genetic testing for tens to thousands of samples, their products and services help laboratories translate genomic discoveries into mainstream clinical practice.

Headquartered in San Diego, with offices located around the world, our client fosters a highly collaborative culture for both our customers and employees, encouraging diversity, creativity, and most importantly, innovation.

RESPONSIBILITIES

• Responsible for building and driving a Quality vision and strategic objectives that aligns with our global operations.

• Leads and develops strong quality leaders, establishing and actively managing performance expectations, and providing development and training opportunities.

• Drive projects and improvements/standardization across the company to improve our Quality management system.

• Ensure global training is effective and that the sites operate within the required regulatory guidelines.

• Influence and build strong working relationships across organizations and geographies and engage with business partners to define existing gaps and future requirements for Quality Management Systems.

• Ensure effective management of the Quality Management System including assuring effective management reviews, complaint handling, on-market surveillance, CAPA system, change control, process validation, internal auditing, R&D transfers, and manufacturing support.

• Drive the continuous improvement of Quality Management Systems at sites around the world, including assuring effective management reviews, complaint handling, CAPA system, change control, internal auditing, R&D transfers, validation, and manufacturing support.

• Support regulatory strategies and programs, providing direction and definition to maintain continuous improvement initiatives that will ensure compliance with all current industry standards and regulatory agency requirements for near-term US- FDA approval of its products (and other global IVD regulating agencies).

• Suport regulatory strategies and policies for the successful approval of all 510(k) or PMA submissions to the FDA, as well as worldwide, such as CE-IVD

• Support the commercialization of New Product Introductions by working within Core Team.

• Ensure compliance to applicable regulations.

• Lead executive quality management reviews.

• Operate in the audit front room for compliance audits from FDA, ISO 13845, Internal auditors, and customers

• Responsible for accomplishing results through management of multiple teams or senior professionals.

• Exercises control over resources, policy formulation and planning.

• Responsible for one or more functional area.

  QUALIFICATIONS

• Bachelor’s degree in Life Sciences, Chemistry, Engineering or other relevant field required; advanced degree preferred.

• A minimum of 10 years of Quality experience within the Medical Device, Pharmaceutical Industry or Life Science industry. Similarly regulatory experience is desired.

• Demonstrated experience working with external customers and commercial teams creating strategies that address customer needs and product specification.

• Previous experience working global teams.

• Previous experience supporting New Product Introductions preferred.

• Able to work with and manage external consultants.

  Skills-

• Possesses  a customer first mindset.

• Applies advanced principles, theories and other concepts. Contributes to development of new principles and concepts.

• Understands strategy of department and functional areas and the interdependencies of each function of the department.

• Maintains and uses contacts throughout the organization, industry, academia, professional organizations and the marketplace.

  Management Strategy-

• Manages multi-department functional area.

• Guided by functional area or department strategy; implements policies and defines approach to strategy achievement.

  Problem-solving-

• Solves extremely complex, multi-faceted problems requiring ingenuity, creativity and resourcefulness; most problems involve data or situational analysis, and evaluation of intangible variables.

• Regularly exercises independent judgment in developing new methods, techniques, and evaluation criteria to obtaining results for complex assignments.

• Ensures budgets and schedules meet department objectives

  Independence-

• Works under consultative direction towards predetermined long-range goals. Assignments are often self-initiated. Determines and pursues course of action necessary to obtain results.

• May provide guidance to subordinate management or high level staff based on organizational goals and company policy.

• May establish operational objectives and assignments.

• Interprets, executes and recommends modifications to organizational policies

• Guides and influences key decisions made by senior management.

• Regularly interacts with senior management or executives. Interactions may involve controversial situations, customer negotiations, or influencing other senior level managers.

• May serve as organizational spokesperson on important projects and projects.

•  Communicates frequently with internal and external top management, acting a advisor to top management and customers on advanced technical research studies and applications.

• Makes formal presentations to senior management.