Director of Quality Assurance

Anaheim, CA

Posted: 12/17/2018 Industry: Laboratory - Industrial Chemicals Job Number: 542.18DM Pay Rate: 150,000

Director of Quality Assurance

Provides leadership and direction to drive site operations towards high quality products and processes in accordance with corporate strategy, cGMP and regulatory compliance.  This includes developing strategic business plans and the tactical actions and resources necessary to execute them.  The Director will be responsible for managing operational budgets (expense and capital budgets).  This position manages the performance of four direct reports:  QA/QC Manager, Document Control and two Microbiologists.  The director is responsible and accountable for all quality assurance oversight and all quality control functions at the facility.

Quality Responsibility

Ensures all products manufactured in the facility and released to market are pure, safe, and effective and meet all established regulatory requirements

  • Keeps current with new guidelines and FDA inspectional and scientific trends and adjust facility procedures appropriately
  • Provides leadership developing and directing quality assurance and improvement initiatives for all company procedures or processes within the site and ensures ongoing compliance with local, national, and international standards and legislation
  • Leads the preparation for regulatory inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs
  • Organizes and hosts facility audits by customers, FDA, and HPRA including responding to corrective actions and/or observations as required
  • Evaluates investigations regarding batch discrepancies, non-conformances and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence. Determines final disposition of the batch using scientific justification

Technical Support

  • Ensures the entire facility operates in conformance with all regulatory requirements. Monitors the facilities compliance on a regular basis and addresses any deficiencies identified
  • Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes and supporting new product development
  • Oversee the Quality Control and Microbiology Laboratory in support of raw material and component release, finished product release and stability testing. Assure that problems are appropriately and scientifically investigated in accordance with GMP and that regulatory reports are filed as needed

Business Development

  • Lead the site transfer process for CMO projects including execution of gap assessment, coordination of technical transfer activities, QA oversight of manufacturing activities and development of Quality Agreements. Primary liaison with customer for quality and manufacturing issues
  • Oversee the Quality of R&D reports and activities for new product submissions
  • Hosts customer audits and ensures corrective actions are completed according to customer specification
  • Responsible for ensuring that all product quality complaints are being adequately investigated, trended, and reported and collaborates with department to ensure full customer satisfaction

Lead and Direct Department

  • Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate / departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance
  • Accomplishes financial objectives by forecasting requirements, preparing an annual budget, scheduling expenditures, analyzing variances, initiating corrective actions
  • Leads by example and proactively communicates and collaborates with internal staff, colleagues, and external stakeholders to drive results

Continuous Improvement

  • Monitors QA systems and advises Director of Quality Assurance, North America on system performance; publishes statistics regarding performance against set goals and makes recommendations
  • Foster a GMP compliant culture in association with continuous improvement initiatives in order to reduce inefficiencies

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Dave Maxwell at 815.756.1221 / dmaxwell@cps4jobs.com.

JO:  542.18DM
#LI-DM1

 

Requirements:

  • BS-PhD Chemistry, Microbiology, Science related
  • 10 years’ relevant experience in a regulated Pharmaceutical Industry including Quality Assurance and / or Quality Control, with 5 years in a leadership role
  • Knowledge of Analytical Chemistry, cGMP, Quality Systems, Drug Regulatory Affairs, Stability protocols and systems, manufacturing and packaging processes
  • Must possess leadership qualities to be able to comfortably and successfully interface and communicate with all levels internally and externally
  • Coach, mentor, teamwork, collaboration
  • Ability to develop a team

**If you’d like to hear more about this opportunity and others we are currently working on, please contact Dave Maxwell at 815.756.1221 / dmaxwell@cps4jobs.com.

JO:  542.18DM
#LI-DM1

 

Dave Maxwell
Sr Technical Recruiter

Senior Level Recruitment Professional with more than 22 years of experience in the recruitment and placement of Industrial Chemists and Scientists Nationwide from Entry level to Executive level.  Resins, Polymers, Adhesives, Coatings, Plastics, Lubricants, Specialty Chemicals, Agricultural Chemicals, Additives, Inks, Consumer Products, and more!

I have been very successful bringing top valued talent to my clients and providing expert level guidance to candidates in career searches.

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