Manager, Quality Control

Description

At Phlow, we are creating the future of how medicines are made. As a pharmaceutical manufacturing company, we are focused on developing and manufacturing critical medicines using innovative approaches to improve the security, reliability, and resilience of the U.S. pharmaceutical supply chain.

We are looking for an experienced Quality Control Manager to join our Quality & Regulatory team. This role will oversee laboratory operations and testing activities supporting raw materials, in-process materials, intermediates, and finished APIs. The Quality Control Manager will build and lead a team of laboratory professionals while ensuring the highest standards of quality, compliance, and data integrity.

This is an opportunity to play a key role in building and strengthening Phlow's quality organization while working closely with our Analytical Development team and other cross-functional partners.

• Lead day-to-day Quality Control laboratory operations, including testing activities, priorities, and schedules.
• Review laboratory data and ensure adherence to data integrity principles and documentation requirements.
• Ensure laboratory activities comply with FDA regulations, cGMP requirements, and Phlow quality standards.
• Review and approve batch records, analytical data, SOPs, and other quality documentation.
• Lead investigations of Out-of-Specification (OOS) results and support the development and implementation of appropriate corrective and preventive actions (CAPAs).
• Build, train, mentor, and develop a high-performing team of laboratory analysts.
• Establish a culture of accountability, collaboration, continuous improvement, and scientific rigor.
• Oversee analytical method validation and verification activities in partnership with Analytical Development.
• Ensure laboratory equipment is properly maintained, calibrated, and qualified.
• Partner cross-functionally with Quality, Regulatory, Analytical Development, Manufacturing, and other teams to support timely release of materials and products.
• Identify opportunities to improve laboratory processes, efficiency, and overall quality performance.

Requirements

• Bachelor's degree in Chemistry, Biology, or a related science field.
• Minimum of 5 to 7 years of QC lab experience in the pharmaceutical industry.
• At least 2 years in a leadership or supervisory role.
• Strong knowledge of HPLC, GC, FTIR, and wet chemistry techniques.
• Deep understanding of data integrity, regulatory audits, and cGMP guidelines.

Physical Requirements

• Work in various positions such as walking, standing, or sitting for prolonged durations, including reaching, bending, twisting, turning, and climbing.
• Exposure to indoor factory conditions and outdoor environments with varying temperatures.
• Ability to lift objects up to 25-35 pounds occasionally.
• Frequent walking, standing, bending, and climbing stairs or ladders to access equipment and platforms

The salary range for this position is $100,000 to $140,000, with the final offer determined based on factors such as the candidate's experience, qualifications, skills, and education. In addition to a competitive base salary, this position is eligible to participate in Phlow's bonus and stock option programs. Phlow also offers a comprehensive benefits package that includes medical, life, and disability insurance; retirement savings plans; paid time off and company holidays; and education-related benefits. Many of these programs are fully funded or significantly subsidized by the company, reflecting our commitment to supporting the health, well-being, and professional development of our employees.