Sr. Director, Quality Assurance and Regulatory Affairs

Overview

Job Summary

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

Key Accountabilities

• Provides expertise and guidance in interpreting governmental regulations, agency guidelines and inter-nal policies to assure compliance.
• Implements policies and procedures to ensure that these are in compliance with the appropriate statu-tes 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 success-fully 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 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 organiza-tion
• Ensures activities are completed within scheduled time frames. (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.

Networking/Key relationships

• Report quality system performance measures to top management.
• Liason and support EU Authorized Representative to ensure compliance to 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 collegues to acheive Werfen quality objectives.

Minimum Knowledge & Experience required for the position:

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.

Skills & Capabilities:

• 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), 21
  
  CFR Parts 210,211, 11, and 820, ISO 14385, ISO 14971 requirements and other…