Director Of Quality And Regulatory Affairs

Hydrox Laboratories Elgin , IL 60123

Posted 3 weeks ago

This position is responsible for development of overall approach to planning, execution and integration of activities to best suit the organization to ensure consumer safety, product quality in compliance with regulations while meeting business needs in the most efficient manner.

Responsibilities:

  • Manage all regulatory and quality activities for the company
  • Develop, implement and evaluate effective processes that are consistently adhered to ensuing consistent practice across all businesses.
  • Develop, implement and evaluate effective processes that are consistently adhered to ensuing consistent practice across all businesses.
  • Liaise with the FDA and international regulatory bodies in ensuring regulatory compliance with worldwide quality system regulations.
  • Develop, implement and maintain quality system policies and procedures of the company.
  • Manage processes to detect, document and execute opportunities for quality improvement.
  • Communicate quality system status at the company through management reviews, quality audits, post-market surveillance and other quality management processes.
  • Oversee the product approval regulatory submissions for all products.
  • Provide leadership in the development of regulatory strategies for submissions of new products or modifications of products.
  • Develop broad regulatory strategies consistent with business objectives and regulatory requirements.
  • Liaise with domestic and foreign regulatory agencies and ministries.
  • Continuously review quality assurance/control philosophy, practices and procedures to ensure the highest standards.
  • Ensure compliance with all regulatory requirements (QSR, MDD, CMDR).
  • Develop and maintain MDR/vigilance compliance and complaint systems.
  • Analyze and make product recommendations in collaboration with R&D and product development.
  • Closely interact with all facets of the company's business.
  • Develop staff competencies to achieve a world-class regulatory compliance culture
  • Ensure completion of departmental tasks and projects and actively gather staff feedback and perspective
  • Manage and participate in human resources/organizational development process and recruitment of key Regulatory and Quality personnel (includes staffing, conflict management, employee and organizational development).
  • Ensure budgets, schedules, staffing, performance and safety requirements are met.
  • Review and approved of all SOPs, standard testing methods, master manufacturing documents and product/raw material specification sheets.
  • Effective management of 17 direct reports, including Quality Assurance, Validation Engineer, Microbiology and chemistry Personnel.
  • Review and approve Microbiology and chemistry test results prior the release of products.

Requirements

Job Requirements

  • Minimum 10+ years of experience in the pharmaceutical industry
  • Experience in managing a multi-disciplined compliance organization, including quality management experience or equivalent combination of education and relevant regulatory experience
  • Experience should include 5+ years of management background
  • Ability to integrate regulatory expertise with business objectives
  • Ability to translate company's corporate goals into project plans
  • Ability to effectively communicate, coordinate and interact with upper management, managers and personnel within other departments
  • Skilled at fully understanding scientific, medical and manufacturing disciplines
  • Thorough understanding of US and international regulatory requirements and standards for development, validation, manufacture, marketing and distribution of products
  • Proven track record of success and a broad understanding of global regulatory affairs and quality management requirements
  • Proven track record of successful cooperative working relationships with the FDA and/or global regulatory agencies
  • Progressive view of regulatory compliance and quality management and the contribution of both in a successful business strategy
  • An effective leader, strong leadership, management and mentoring skills, team-oriented

Benefits

core benefit package that consists of medical, dental, vision, short-term disability, long-term disability, life insurance, 401(k) plan, Holiday pay, PTO and vacation pay.

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Director Of Quality And Regulatory Affairs

Hydrox Laboratories