Responsible for ensuring that quality system requirements are effectively established and maintained in accordance to applicable national regulations and international standards and reporting on the performance of the quality system to Microbiology Division (MBD) Americas senior management.  Responsible for continuous improvement of the quality system to develop toward a best-in-class system.  Responsible to ensure alignment among the MBD US manufacturing and distribution sites and with regional colleagues and quality systems OUS. 

Major Responsibilities:

• Ensure the MBD-US Quality System is established, implemented, and maintained in compliance with the applicable FDA Quality System Regulation, ISO 13485:2003, the Medical Device Directive (93/42EEC), and the Canadian Medical Device Regulations (CMDR).  Manage and maintain the MBD US Master Quality Plan and the MBD US Quality Policy and goals.

• Educate, train, advise, and coach company professionals to ensure compliance with applicable regulations.  Work across MBD-US to ensure a consistent approach to regulations is adopted throughout the business.

• Develop departmental objectives and timelines, and ensure their timely completion.  Implement frequent benchmark analyses within our client and the industry to ensure best practice adoption and implementation.

• Achieve continuous quality improvement through Lean and PPI initiatives to enhance both profitability and customer satisfaction.  Benchmark other quality systems internal and external within the industry; implement best practices identified through benchmarking.  Share best practices among MBD sites worldwide and work to standardize processes where practical.

• Maintain a quality system that meets the requirements of 21 CFR part 820 including management review, complaint handling with analysis and trending, corrective and preventative action, and internal and supplier audits.

• Assure timely, accurate, and efficient record keeping including accurate document controls, and up-to-date revision controls for Standard Operating Procedures, raw material specifications, test and release criteria for finished goods, as well as product labeling and package inserts.  

• Monitor, analyze, and advise MBD-US on existing and emerging global regulatory trends and requirements, laws, regulations and practices effecting import/export licensing/compliance and the Occupational Safety and Health Administration (OSHA).

• Provide validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.  Review, assess, and evaluate validation protocols for compliance to procedures and regulations.

• Develop, plan, direct, and implement organization safety policies and procedures to prevent work-related injuries and health conditions.  Identify specific goals and objectives required to maintain and improve the company safety programs and performance.

• Maintain all regulatory and environmental permitting for the MBD US manufacturing and distribution sites.

• Direct all activities related to import and export compliance.  Maintain working knowledge of International Traffic in Arms Regulations (ITAR), Export Administration Regulations (EAR), US Customs regulations, and Harmonized Tariff Schedule.

• As the designated Management Representative, interact with all agencies and institutions that regulate or assess the MBD US quality system and regularly report the effectiveness of the system to MBD Americas senior management.

• Assume leadership role in regulatory across the division, making practical regulatory decisions that enable the business to meet its needs while maintaining compliance, and driving the decisions to local implementation through divisional colleagues.

• In addition, other duties may be assigned as the need arises.

Minimum Requirements:

• Possess minimum of seven years experience in a leadership role in regulatory affairs and/or quality systems in the biotechnology industry, preferably in in vitro diagnostics.

• B.S. degree, biological or life science

• Excellent knowledge of federal, state and local regulations for FDA and ISO 13485.

• Effective leadership, interpersonal, and performance management skills.

• Excellent organizational and problem-solving skills.

• Demonstrated ability to lead the regulatory, quality and EH&S functions at remote locations.

• Experience with Health Canada, the European IVDD and other international regulatory agencies preferred.