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.


  • 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.


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


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.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Admissions Director / Coordinator

Greystone Healthcare Management

Posted 7 months ago

VIEW JOBS 4/7/2020 12:00:00 AM 2020-07-06T00:00 Overview Conveniently located less than two miles from Amita Health St. Joseph Hospital and Advocate Sherman Hospital, Fox River Rehab and Healthcare is tucked into the bustling community of Elgin. Fox River provides top of the line care and rehabilitation services, designed around our residents' needs. Through personalized care plans our residents experience quality care in our 139-bed center. Fox River is among the 19% of U.S. skilled nursing facilities that have been recognized as a Best Nursing Home for 2019-20 by U.S. News and World Report. Responsibilities Heroes Work Here, Work Where People Matter! Healthcare workers are ESSENTIAL employees and often unsung heroes, putting their lives on the line daily to help others. In the face of the COVID-19 pandemic, we are looking for heroes that want to come join our TEAM and HELP others. If you are passionate about taking CARE of others and LOVE what you do, Greystone Health is the place to work. We LOVE OUR HEROES and their families for the selflessness they demonstrate in taking care of our residents and their families. JOIN US NOW! Our community has an opportunity for a driven, caring, and passionate Admissions Director. The Admissions Director coordinates patient admissions with physicians, hospitals, attorneys, case managers and families to provide continuum of care for our customers. He/she will attend daily, weekly and monthly census meetings, and complete fiscal year trends, goals and market analysis for the Administrator and corporate office. Additional responsibilities include: * Identifying and providing for each customer's social, emotional, and psychological needs * Ensuring the continuing development of the customer's full potential during his/her stay at the community * Assist in the planning for patient discharges * Acting as a liaison between the facility and the outside community * Develop strategies to maximize admissions of patients requiring a sub-acute level of care. Qualifications * Potential candidate must possess a high school diploma and at least 3 years' experience in Health Care Sales, Marketing, Insurance or commensurate education. * Must be proficient in writing reports, business correspondence and policy procedure manuals. * Must be able to interpret an extensive variety of technical instructions in statistical or diagram form. * Demonstrate ability to function independently and possess strong leadership skills. * Establish and maintain positive relations with members, families, staff and visitors. * Knowledge of regulatory standards and compliance requirements. Benefits Depending upon your job classification you may be eligible for participation in our comprehensive benefits program. * Health, dental, vision and life insurance. Your well-being is important, and we value it. * Paid time off. Because as much as you love your job, we want you to also love having time to be you. * A 401K retirement plan. You're our company's future; let us help you take care of yours. * Continuing education credits. Life, learning, and education are our top priorities. * Tuition reimbursement. The more you know, the more we can grow together. * Referral bonus program. Refer a friend. Receive a bonus. Help us build great teams. * As a growing organization, we offer many different career paths to help you achieve your professional goals The best people, the best communities, the best services for the best reason: Serving our patients. That means making sure we have the best team available who believe that taking care of our staff is just as important to us as taking care of our patients. Click Apply to join the Greystone Health Family! Go to our website for more info and career opportunities Like Us on Facebook under Greystone Healthcare Management Follow us on Linked In under Greystone Health Network Greystone Healthcare Management Elgin IL

Director Of Quality And Regulatory Affairs

Hydrox Laboratories