Sr. Director, Quality Assurance and Regulatory Affairs

Sr. Director, Quality Assurance and Regulatory Affairs

Join to apply for the Sr. Director, Quality Assurance and Regulatory Affairs role at Werfen North America.

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Responsible for the site Quality system and leadership of the site Quality Assurance, Quality Control and Regulatory Affairs organization.

• Ensures that a site Quality Management System is established, implemented and maintained for product manufacturing, control, storage, and primary distribution processes in accordance with applicable US Federal Regulations, Regulation EU 2017/746, EN ISO 13485 standards and site Quality requirements.
• Act as the QA-RA representative of the site leadership team and sponsor Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations and directs GMP aspects of plant activities.
• Interface with other top management personnel to set policy and to assure adherence to these, in addition to governmental standards.
• Responsible for the decision on acceptability and release of all site products.
• Organizational responsibilities include site Quality Assurance, Quality Control and Regulatory Affairs documentation, and regulatory inspection/customer audit liaison activities. Additional responsibilities include site department budget, hiring and development of personnel, and management of the Quality and RA organization.
• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
• Implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations and ensures that regulatory reporting requirements are met.
• Ensures regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management.
• Responsible for the overall surveillance and operation success of assigned functions and for successfully integrating these activities with those of other major organizational segments.
• Serves as the site Management Representative and Person Responsible for Regulatory Compliance (PRRC), as defined by 21
  
  CFR part 820 and the In Vitro Diagnostic Regulation (IVDR) Regulation (EU) 2017/746.
• Directs the risk management and design control strategy for the development and manufacture of new and existing Medical Device products.
• Acts independently, guided only by very broad company policies and objectives. Makes final decisions on administrative or operational issues affecting major segments or functional activities of the organization.
• Ensures activities are completed within scheduled time frames (e.g., regulatory submissions/reports, CAPAs, investigations, MDRs/Vigilance/FSCA/complaint closure, etc.).
• Ensures adequate training (and documentation) of employees within the departments listed above.
• Prepare, maintain and ensure adherence to departmental budgets.
• Report quality system performance measures to top management.
• Liason and support EU Authorized Representative to ensure compliance with EU regulation, regulatory correspondence, and maintenance of technical documentation.
• Partner with the site operations leader to meet quality and compliance objectives, design goals, and production targets.
• Interface with Werfen RA.QA colleagues to achieve Werfen quality objectives.

B.S. Degree or equivalent in Science or Engineering. Minimum 10 years experience in a management capacity covering a span of responsibility within Quality Assurance and Regulatory Affairs within the IVD, Medical Device and/or biopharmaceutical industry. Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

• Demonstrated track record in successful US FDA, EU and ROW premarket audits/inspections and regulatory submission, including 510(k) and IVDR/MDR.
• Ability to establish processes and systems meeting Quality System Regulations (QSR), 21
  
  CFR Parts 210,211, 11, and 820, ISO 14385, ISO 14971…