Senior Director, Quality (Biopharma)

Location: USA - NC - Durham - Hamlin Rd

Salary: $205,000–$283,000 per year

Company

hirify.global is a contract manufacturer of microbial fermentation and mammalian cell culture protein therapeutics.

What you will do

• Lead the Quality Assurance, QC Analytical, and QC Microbiology functions at the site.
• Oversee raw material release, quality oversight on the manufacturing floor, drug substance disposition, and review of quality control data.
• Manage deviations, Change Control, CAPA, root cause analysis, risk management, document and records management, training, and quality metrics.
• Oversee QC Analytical testing and QC Microbiology activities, including bioburden, endotoxin, environmental monitoring, water testing, media quality control, trending, and raw material programs.
• Partner with Global Quality, site operations, clients, and suppliers on audits, regulatory inspections, quality strategy, and continuous improvement.
• Hold final accountability and decision-making authority for site GMP compliance in consultation with the SVP of Quality and Regulatory.

Requirements

• Bachelor of Science degree in a scientific discipline with at least 8 years of quality management experience and 5 years in relevant technical management; a Master’s or PhD may qualify with less experience.
• At least 15 years of experience in the regulated pharmaceutical industry; contract manufacturing organization experience is preferred.
• Thorough knowledge of cGMPs, biotechnology-derived product regulations, and 21 CFR 210 and 211.
• Experience managing regulatory inspections and implementing quality systems, standards, procedures, and strategic plans.
• Strong collaboration, team-building, mentoring, customer service, integrity, innovation, and personal responsibility.
• Ability to analyze complex scientific and technical documents, communicate with senior stakeholders, use spreadsheets and presentation software, and sit or stand for extended periods.

Culture & Benefits

• Work as part of the site senior leadership team and contribute to long-term strategic planning.
• Collaborate with Manufacturing, Facilities & Engineering, Supply Chain, EHS&S, Operational Excellence, clients, and Global Quality.
• Support inspection readiness, operational growth, quality-system adherence, and continuous improvement.
• EEO/AA employer committed to workforce diversity.