Quality Control Manager

Summary of Primary Responsibilities:

Responsible for managing all microbiological and chemical testing of production materials and incoming inspection of raw materials under GMP conditions in accordance with agreed upon timelines and schedules. In coordination with R&D and Technology Transfer, responsible for method development, method validation and testing for developmental products. Responsible for development, implementation and maintenance of Quality Control systems.

Specific Responsibilities:

  1. Ensures laboratory compliance with FDA regulations, GMP and GLP guidelines.
  2. Schedules testing of raw materials, in-process samples, bulk and finished products and stability samples in conformity to standards and approved specifications, and on timelines to meet targets for product release.
  3. Provides plans for new projects, processes and method development needs in conjunction with Technology Transfer and R&D.
  4. Manages Quality Control Staff to include goal setting, performance appraisals, and professional development.
  5. Ensures training on new methods, SOPs and other technical requirements is completed for all Quality Control staff.
  6. Develops budgets for staff, equipment and supplies and monitors expenditures.
  7. Approves changes to Quality Control and production processes and materials to meet specifications, optimize efficiencies and control costs.
  8. Reviews results for developmental product testing and finished product testing for commercialized products.
  9. Manages commercial product stability program.
  10. Manages new product stability program.
  11. Reviews and approves Technical Reports.
  12. Provides data and reports in support of the Quarterly Quality Systems Management Review and environmental and personnel monitoring programs.
  13. Reviews and approves Document Changes as required.
  14. Schedules and Monitors in house instrument calibration and preventive maintenance program.
  15. Other duties and projects as assigned.

Job Complexity:

Works on problems of diverse scope requiring evaluations of identifiable factors. Exercises considerable judgment within generally defined practices and policies. Acts as advisor and trainer to unit to meet schedules and/or resolve technical problems. Erroneous decisions or failure to act could cause critical delays in schedules and impact business activities. Interacts with peer groups, senior management and outside customers. Normally receives no instruction on routine work, general instructions on directions for departmental and quality systems development.

Supervisory Responsibilities:

Supervises Analysts, Technicians, Lab Assistants, and Microbiologists

Experience, Knowledge, and Skills Required:

  1. Bachelors degree in Biology, Microbiology or Chemistry required with Master’s degree preferred.
  2. Requires a minimum of 5+ years experience in a FDA regulated drug/device industries, with Quality Control experience required
  3. 3+ years of supervisory experience required
  4. Ability to manage multiple priorities
  5. Excellent interpersonal skills
  6. Excellent verbal and written communication skills with the ability to prepare and make formal presentations at the senior manager level
  7. Experience with QMS systems a plus

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