Director of Quality Control, Pharma

Role Summary

As the Director of Quality Control, you will provide both strategic and operational leadership for the Pharma Site Quality Control (QC) Operations organization. In this role, you will oversee a team dedicated to ensuring high standards of quality through chemical, biochemical, and biological analysis of drug substance and drug product materials manufactured in Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose operations at RTP Pharma. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments and testing procedures, contributing to site strategy, global milestone projects, and adherence to regulatory requirements in support of the clinical and commercial supply chain.

Responsibilities

• Lead the Pharma Site QC Operations organization – manage effective and compliant cGMP QC laboratory operations and partnerships within Global Quality; plan, implement, and direct activities of QC Operations Lab supervisors and managers in sampling and testing; provide technical support and facilitate major investigations to support business and manufacturing schedules.
• Accountability for QC personnel staffing, training, development, and performance in GMP-compliant Quality Control operations; ensure adherence to safety regulations.
• As an extended member of the RTP Pharma Site Leadership team, contribute to organizational focus and strategic planning.
• Establish and maintain laboratory systems to ensure integrity of all results; ensure tracking and trending for QC functions; responsible for audits and site management reviews; ensure tasks meet business initiatives within timeframe.
• Collaborate with Manufacturing, MFG Sciences, Technical Development, Quality Assurance, Regulatory, and Global Quality to enable cross-functional success.
• Develop and manage QC budget plans, ensuring financial discipline aligned with near-term and long-term growth.
• Manage key site and global milestone projects, maintaining adherence to regulatory licenses and regulations.
• Provide technical support, facilitate major investigations, and ensure QC laboratory operations support business and manufacturing schedules.
• Drive compliance and quality by supporting analytical method and process validation, instrument qualifications, and safety adherence.

Qualifications

• Required: Bachelor’s degree (B.S.) in Microbiology, Chemistry, Biochemistry, Biological Sciences, or a related field.
• Required: A minimum of 12 years of relevant experience, including direct people leadership of 6+ headcount, with advancement to site leadership and organizational levels.
• Required: Strong understanding of GMP-compliant Quality Control operations within a biotechnology setting.
• Required: Experience with creating a robust environmental monitoring program.
• Required: Experience with parenteral filling (sterile filling for vials, cartridges, and syringes) and/or Antisense Oligonucleotides.
• Required: Demonstrated ability in developing and managing budgets and QC infrastructure.
• Required: Proven track record of cross-functional collaboration and project management.
• Required: Expertise in laboratory systems, analytical methods, and regulatory compliance.
• Required: Proficiency in data analysis, trending, and reporting within a QC framework.
• Preferred: Experience with strategic planning and execution in a global quality context.

Education

• Bachelor’s degree (B.S.) in Microbiology, Chemistry, Biochemistry, Biological Sciences, or a related field.