CLIA QA/RA Compliance Lead
The CLIA QA/RA Compliance Lead will be a strong partner to the Global Quality and Regulatory function, as well as across the Molecular Solutions Business Area.
- Leads and coordinates Quality Systems activities. Assures local and partner Quality Management Systems (QMS) compliance with FDA and/or CLIA Quality System Regulation (QSR) and International Standards Organization (ISO) regulations. Provides direction and strategic insight to senior management to establish, implement, and maintain policies and procedures designed to ensure compliance with all necessary and appropriate quality standards.
- Regularly interacts with senior leadership and across organizations, levels, and groups to establish short to mid-term objectives to align with company vision and accomplish organizational goals. Works to influence senior management to modify area or company-wide policies and to change thinking or gain acceptance of new concepts or programs.
- Partners with the Molecular Solutions organization to develop strategic Quality Systems initiatives that have high visibility or significant business impact and works to ensure they are implemented, including integration, harmonization, continuous improvement, and Quality Systems technology advancements.
- Leads complex cross-functional project teams that may be global in nature, acts as organizational matrix manager, and makes mid- to long-term decisions that may impact broad organizational objectives.
- Responsible for ensuring continuous process improvements and other Corrective and Preventive Action programs are executed to maintain compliance with Federal, State, and local regulations pertaining to QSR, ISO, and associated Regulatory agencies.
- Performs training to meet business requirements. Responsible for ensuring the local organization is trained on QSR, ISO, and other associated Regulatory requirements through the development and implementation of compliance education and training courses.
- Serves as subject matter expert and thought leader with Regulatory agencies and professional organizations to ensure the Quality Management System remains current and competitive.
- Interacts with local and global Information Management functions to evaluate, test, and implement programs or changes linked to Information Technology systems or data analytics. Applies business process knowledge to manage the design and improvement of quality processes to improve system utilization while maintaining compliance; presents new or upgraded system capabilities and drives knowledge to users.
- May have responsibility for management of area budget; ensures deadlines and budgets are met. Works with Procurement on contract negotiations and/or supply/quality agreements. May manage external resources, including consultants.
- Expected to operate independently and highly autonomously, holding him/herself accountable to proactively fulfill tasks and achieve results within assigned timelines. Works on highly complex issues; develops solutions based on technical expertise and consults with senior management on critical matters where applicable.
- Expected to understand strategic priorities developed by upper management and to respond to requests with appropriate urgency and with an organized approach.
- Bachelors’ degree in Biological Sciences, Quality Engineering, Business Administration or related field, or equivalent combination of education and work experience
- Master’s degree/PhD, or equivalent preferred
- 10+ years minimum (12+ preferred) of relevant medical diagnostic/device industry experience, including experience focused on quality systems, regulatory affairs/compliance, project management, controlled documentation, quality data analytics, or change control.
- Thorough working knowledge of relevant international ISO Standards (ISO 13485, 14971) and regulations (IVDD/IVDR, 21 CFR - part 820)
- Enthusiasm for the role that Quality and Regulatory (Q&R) can play in enabling the development and manufacture of products for our patients
- Drive to engage positively with Q&R/Business teams and make impactful contributions in a multi-cultural/national environment
- Track record of providing sound Q&R judgment/ideas and business partnering
- Strong leadership/interpersonal/integrating/problem-solving skills and demonstrated ability to collaborate effectively across a variety of workgroups in demanding/changing situations (medical, scientific, and manufacturing)
- Strong communication skills, with ability to get points across clearly and simply