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.
What You'll Do- 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.
