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. You will oversee a team dedicated to ensuring the highest standards of quality through chemical, biochemical, and biological analysis (microbiology) of various stages of drug substance and drug product material manufactured in Parenteral Filling, Antisense Oligonucleotide, and Oral Solid Dose (OSD) operations. You will develop and manage QC budget plans and lead the management of laboratory quality systems, including analytical instruments and testing procedures. Your contributions to site strategy, global milestone projects, and adherence to regulatory requirements will support the clinical and commercial supply chain.

Responsibilities

• Lead the Pharma Site QC Operations organization ‚Äî manage effective and efficient cGMP compliant QC laboratory operations and partner with 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 in support of business and manufacturing schedules.
• Be accountable for QC personnel staffing, training, development, and performance in GMP-compliant Quality Control operations. Ensure safety regulations and requirements are met.
• 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 laboratory results. Ensure tracking and trending for QC functions. Responsible for audits and site management review. Ensure tasks meet business initiatives within a suitable 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- and long-term growth strategies.
• 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 regulation adherence.

Qualifications

• Required: Bachelor‚Äôs 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 and exposure at 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 successful 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

Skills

• Leadership and people management in a GMP environment
• Strategic planning and cross-functional collaboration
• Quality systems, audits, and management review processes
• Analytical method development and validation, instrument qualification
• Environmental monitoring programs and biosafety awareness
• Data analysis, trending, and reporting within QC