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Director of QA/QC (Pharma)- San Diego, CA

Company: Kelly
Location: Encinitas
Posted on: November 14, 2021

Job Description:

Director of QC/QA - San Diego, CA Summary: This position assumes overall responsibility for successfully leading, directing and managing the organization's Quality Control and Quality Assurance functions. Responsibilities:

  • Manage and provide strategic leadership for QC/QA strategy, regulatory agency interactions, and day to day laboratory and quality assurance functions.
  • Provides high level strategic and quality control/quality assurance direction and mentorship on projects.
  • Provide strategic interpretation and guidance to project teams from early development through final approvals
  • Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Company personnel and assist as a liaison between the Company and regulatory authorities
  • Identify and communicate regulatory risks and develop risk mitigation strategies
  • Develop and manage timelines for QC/QA for all projects
  • Manage all 3rd Party contractors/consulting agencies supporting QC/QA functions
  • Manage and lead the Corrective and Preventive Action (CAPA) program to manage product and process non-conformances.
  • Manage quality management systems with the requirements of ISO 13485, and other relevant ISO standards as applicable and as amended
  • Lead and manage the Quality function and provide support for all manufacturing and supply chain operations:
  • Ensure qualification of manufacturing processes and analytical test methods
  • Oversee generation and review of internal and external documents (SOPs, specs, etc.)
  • Ensure change management protocols are followed
  • Ensure ongoing compliance with relevant GXP and other relevant industry standards
  • Manage all specifications (product, raw material, packaging)
  • Select, develop, and evaluate personnel to ensure the efficient operation of the function
  • Assist with the selection, auditing, and management of contract organizations, including manufacturers (CMOs), warehouses, laboratories, and suppliers, and ensure compliance with relevant GXP standards and other regulatory and business requirements Support Commercial Sales:
    • Complete customer questionnaires
    • Obtain relevant industry certifications
    • Rapidly respond to all customer complaints and lead CAPA program
    • Train employees, as required, on Quality related procedures and protocols
    • Motivate employees to fulfill their obligations and inspire them to want to achieve results, and has the managerial courage to establish consequences when necessary
    • Maintains awareness of recent developments in industry, clients, competitors, and regulatory agencies
    • Ensures that safety standards are maintained
    • Embodies Company's cultural values and aligns daily actions with department goals and company culture Requirements/Qualifications:
      • Bachelor's degree in a relevant scientific area is required (Biology, Biochemistry, Chemistry, Engineering), Master's or PhD preferred
      • Minimum 10+ years of Quality Control/Quality Assurance experience in a GXP regulated environment, pharmaceuticals, preferred but would consider similar industries
      • Minimum 5 years' Leadership/Management experience
      • Full understanding of Quality Management Systems requirement
      • Knowledge of cGMP regulations ISO 13485
      • Excellent organization, prioritization, time management and planning skills
      • Excellent written and oral communication skills
      • Demonstrated ability to handle highly confidential materials in a discrete and professional manner
      • Approachable, solutions-oriented and able to maintain composure
      • Ability to use discretion and problem-solving skills to help prevent critical delays in schedules and/or unit operations
      • Experience with Contract Manufacturing Operations (CMO) is strongly preferred
      • Experience managing outside consultants is a plus
      • FDA inspected facility management experience required
      • Understanding of aseptic processes, equipment, automation, validation, cleanrooms, and other classified area requirements
      • Highly skilled at Interdepartmental business relationships and efficient at removing barriers For immediate consideration apply today! Questions? Please reach out to Dustin at #TJP2021_SPEC Why Kelly -- ? Kelly-- Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed. About Kelly -- At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world. Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ]]

Keywords: Kelly, Encinitas , Director of QA/QC (Pharma)- San Diego, CA, Executive , Encinitas, California

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