Executive Director of Quality and Compliance

Company: CoreRx
Location: Clearwater
Posted on: April 2, 2021

Job Description:

CoreRx, a--dynamic--pharmaceutical technology company that--empowers--its--employees--with responsibility and offers a--supportive--and highly progressive work environment. At CoreRx you will find a challenging career path directed towards--growth and opportunity. We employ talented, motivated people - team players who are--innovative thinkers. We offer our employees a--comprehensive, competitive program of benefits and a corporate culture based on--core values that include innovation, a results-oriented focus and ethical behavior. Please submit resumes and cover letters to careers@corerxpharma.com or alejandra.ortiz@corerxpharma.com Executive Director of Quality and Compliance Director of Marketing Empower System Administrator Senior Process Engineer Formulations Research Associate Analytical R&D Chemist Analytical QC Chemist II Senior Quality Assurance Specialist Quality Assurance Inspector Project Logistics Associate Executive Director of Quality and Compliance CoreRx, a--dynamic--pharmaceutical technology company that--empowers--its--employees--with responsibility and offers a--supportive--and highly progressive work environment. At CoreRx you will find a challenging career path directed towards--growth and opportunity. We employ talented, motivated people - team players who are--innovative thinkers. We offer our employees a--comprehensive, competitive program of benefits and a corporate culture based on core values that include innovation, a results-oriented focus, and ethical behavior. This position will be responsible for the successful operation of the Quality and Regulatory Affairs organization integral to the design, manufacture, delivery, and service of our client's products. Reporting to our Chief Executive Officer, you will be responsible for guiding a rapidly growing FDA-registered company through an ever- changing and dynamic global regulatory environment. Candidate must have the following skills and experience: EXPERIENCE AND EDUCATION REQUIREMENTS

• A minimum of 10 years of experience in Quality Assurance, Operations Quality Control, Risk Management and Regulatory Affairs and at least Five years Supervisory/Managerial Role.
• MS degree in Engineering or Sciences required, Ph.D. preferred.
• Experience in the pharmaceutical manufacturing industry with a specific focus on--global--regulatory compliance. Executive level leadership in pharma:
  • Experience in design assurance/control and operations quality.
  • Supervisory experience
  • Customer service in CMO/CRO
  • ANDA/NDA/SUPAC changes
  • QC Lab knowledge, if not experience
  • Validation of equipment/computers/facilities/analytical methods
  • OOS & Deviations & CAPA
  • Experience leading or actively participating in FDA and EMA (and other global regulatory agencies) inspections required.
  • Proven history of driving continuous improvement across the organization.
  • Technical aptitude and background with Pharmaceutical product manufacturing.
  • Demonstrated comprehensive expertise in the applied interpretation of worldwide regulatory standards and laws applicable to the
  • Pharmaceutical industry e.g., ISO, QSR, GMP, etc.
  • Experienced and knowledge in all regulatory compliance aspects of products - commercial, post market, and regulatory.
  • Demonstrated expertise in the design, implementation and measurement of quality systems and metrics.
  • Initiative in innovative approaches to quality and compliance in a fast-paced changing business environment.
  • Excellent written and oral communication and organizational, project management skills.
  • Ability to continuously assess the effectiveness of functional processes and to lead progressive improvement initiatives applying
  • Principles of process excellence.
  • Must have good judgment and ability to take prudent risks. If you're a dedicated take-charge professional who is flexible and
  • Great at multi-tasking while thriving in a fast paced ever-changing environment, then you are the person for us!
  • Establishing and maintaining relationships with regulators, global affiliates and key customers, both internal and external, to
  • ensure strategic regulatory compliance in all aspects of product development and manufacturing;
  • Collaborating with customers and suppliers on quality, regulatory, technical and business issues.
  • Develop and implement global regulatory and compliance strategies to:
  • Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
  • Optimize and focus on quality during the design control processes for both new and existing products;
  • Change management with a focus on standards and compliance excellence.
  • Lead the corporation in the development, maintenance and use of effective quality standards.
  • Establish effective quality measurements throughout our flow paths.
  • Direct effective and efficient continuous quality and cost improvement efforts
  • Preparation of documentation for regulatory submissions and approvals.
  • Drive the Quality and Regulatory Affairs organization and processes to align and meet business goals.
  • Hire, train and develop QA staff and conduct Performance Reviews to assure highly effective teammates PHYSICAL DEMANDS:--Able to stand and/or sit for long periods of time. Notification to Agencies: Please note that CoreRx Inc. does not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Master Service Agreement, and specific approval to submit resumes to an approved requisition, CoreRx Inc. will not consider or approve payment regarding recruiter fees or referral compensations. Job Type: Full-time Location 14205 Myerlake Circle
    Clearwater, FL 33760 USA Contact Us Phone: 727.259.6950
    Toll Free: 877.461.4448
    Fax: 727.683.9530

Keywords: CoreRx, Clearwater , Executive Director of Quality and Compliance, Executive , Clearwater, Florida