Sr. Director, Quality

Senior Director of Quality, Quality Site Head at a contract manufacturer of microbial fermentation and/or mammalian cell culture protein therapeutics. Lead a Quality Assurance and Quality Control team which includes both QC Analytical and QC Microbiology. The individual in this role is recognized as a subject matter expert with regard to Quality Assurance and Quality Control.

• Accountable for raw material release and quality on the floor.
• Disposition of drug substance, QA review of quality control data, root cause analysis, risk management, deviation, Change Control and CAPA management.
• Document/records management, quality metrics reporting, data integrity, training management, QA review of method qualification/validation, process qualification/validation, equipment/utilities/facilities qualification, and continuous improvement.
• Partner with Global Quality to ensure internal audits, client audits, supplier quality management, regulatory inspections, and quality systems implementation at the site.
• Final accountability for GMP compliance for the site, in consultation with the SVP of Quality and Regulatory.

• Accountable for QC Analytical and QC Microbiology oversight.
• Oversight of QC Analytical testing and QC Microbiology tasks including Bioburden, Endotoxin, TOC Conductivity, Water collection Osmolality, EM collection and testing, Organism/Media QC, EM Trending, Sample Accessioning, and Raw Material Program Management.
• Proven knowledge of 21
  
  CFR
  210 and 211 is required.

• Oversee and implement quality systems, standards, and procedures for inspecting, testing, and evaluating manufactured product.
• Ensure the site is inspection‑ready at all times.
• Collaborate with other Quality Site Heads on continuous improvement initiatives.
• Lead, assess, mentor, and develop departmental associates; manage performance and guide professional growth.
• Key contributor to long‑term strategic planning and part of senior leadership team.
• Work with internal and client teams to establish quality strategy, define roles, and problem‑solve.

• Bachelor of Science degree in a scientific discipline with 8 years of quality management experience plus at least 5 years in a relevant technical management capacity.
• Equivalent experience:
  Master’s degree with 6 years of quality experience or PhD with 4 years.
• At least 15 years of regulated pharmaceutical industry experience; CMO experience preferred.
• Thorough knowledge of cGMPs and biotechnology‑derived product regulations.
• Demonstrated track record in regulatory inspection management, strong orientation for quality and customer service, collaboration and team‑building skills, support of growth and profit objectives through quality system adherence, respect for individuals, high integrity, innovation record, and strategic plan development and execution.

• Ability to read, analyze, and interpret complex documents.
• Ability to respond effectively to sensitive inquiries or complaints; to write speeches and articles using original or innovative techniques.
• Ability to make effective and persuasive speeches and presentations on complex topics to senior management, employee groups, customers, and boards of directors.
• Ability to apply logical or scientific thinking to a wide range of intellectual and practical problems.
• Understanding of nonverbal symbolism (formulas, scientific equations, graphs, etc.) in complex phases.
• Ability to deal with abstract and concrete variables.
• Ability to apply advanced mathematical concepts (exponents, logarithms, quadratic equations, permutations).
• Ability to perform statistical analysis: frequency distribution, test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis.
• Ability to sit or stand for long periods.
• Proficiency with computer, phone, spreadsheets, PowerPoint, Outlook.

Range: $ / yr - $ / yr

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