Sr. Director, Quality Assurance & Regulatory Affairs

Overview

Werfen

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.

We are seeking a driven and results-oriented leader to join our Quality team. In this role, you will be 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, sponsoring Quality and Compliance-focused culture which embraces Right First Time and Continuous Improvement expectations and directing GMP aspects of plant activities.

• Interfaces 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

If you are interested in joining an organization where your talents and expertise will be highly appreciated, and if you meet our qualifications to excel in this position, we want to hear from you.

This position is not eligible for sponsorship for work authorization. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Sr. Director, Quality Assurance & Regulatory Affairs

Responsibilities

Key Accountabilities:

• 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.

• Ensure regulatory filing strategies and market authorizations are developed and supported through product development and lifecycle management

• Ensure 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 21CFR part 820 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 timeframes. (i.e. 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.

Sr. Director, Quality Assurance & Regulatory Affairs

Qualifications

Minimum Knowledge & Experience required for the position:

• B.S. Degree or equivalent in Science or Engineering.

• Minimum of 10 years in a management capacity covering a span of responsibility within Quality Assurance and Regulatory Affairs within the IVD, Medical Device and/or bio-pharmaceutical industry

• Demonstrated track record in successful US FDA, EU and ROW premarket audits/inspections and regulatory submission, including 510K and IVDR/MDR.

• Ability to establish processes and systems meeting Quality System Regulations (QSR), 21CFR Parts 210,211, 11, and 820, ISO 14385, ISO 14971 requirements and other related regulations with emphasis in CAPA Systems.

• Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Sr. Director, Quality Assurance & Regulatory Affairs

Werfen appreciates and values diversity. We are an Equal Opportunity/Affirmative Action Employer M/F/D/V

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 5,000 employees around the world comprise our Werfen team.

www.werfen.com