Quality Control Manager

PL Developments Careers•Miami, FL

1d•Onsite

About The Position

The Quality Control (QC) Manager is responsible for leading and managing Quality Control laboratory operations to ensure the timely testing, release, and compliance of raw materials, in-process materials, bulk, stability, and finished products. This role ensures adherence to current Good Manufacturing Practices (cGMP), FDA regulations, and company quality standards while providing strong leadership, technical expertise, and continuous improvement within the QC function.

Requirements

Bachelor’s or Master’s Degree in Chemistry, Biology, or a related scientific discipline
Minimum of 7 years of experience in a Quality Control laboratory environment within a regulated industry (pharmaceutical, biotech, or related)
Strong working knowledge of cGMPs, FDA regulations, and FDA guidance documents
Demonstrated leadership and people management experience
Proven ability to plan, organize, and manage multiple priorities and projects simultaneously
Strong attention to detail with consistent focus on data integrity and compliance
Ability to work effectively in a fast-paced, matrixed environment, both independently and as part of a team
Excellent verbal, written, and interpersonal communication skills
Computer proficiency, including experience with laboratory systems and standard office software

Responsibilities

Directly supervise and provide leadership to QC laboratory technical and support staff
Manage the development, implementation, and continuous improvement of QC goals, objectives, procedures, and systems in alignment with company policies and cGMP requirements
Establish, review, and maintain analytical procedures, methods, and testing guidelines
Establish and maintain testing schedule to assure adherence to Quality On Time Release (OTR), including Raw Materials, In-Process, Finished Product and Stability
Recruit, train, coach, and develop QC staff; assign work, monitor performance, and conduct performance evaluations
Perform or oversee analytical testing, data review, and approval activities as needed
Oversee raw material testing, in-process testing, bulk testing, stability testing, and finished product testing
Supervise and participate in stability programs, method transfers, and analytical method validations
Ensure the development, review, approval, and maintenance of Certificates of Analysis for bulk and finished products
Oversee the laboratory equipment qualification, calibration, and maintenance programs
Lead laboratory investigations, deviations, OOS/OOT investigations, and recommend corrective and preventive actions (CAPAs)
Develop, review, and maintain Quality Control Standard Operating Procedures (SOPs)
Support internal and external audits, inspections, and regulatory agency interactions as required
Partner cross-functionally with Quality Assurance, Manufacturing, R&D, and other departments to support product quality and continuous improvement initiatives
Perform additional duties as assigned by the Head of Quality
Ensure QC Laboratory compliance with 21 CFR 210 & 211 and Part 11
Lead as an QC SME for Internal, Client and Regulatory Audits as needed