Quality Control Manager

Job Summary:

The Quality Control Manager provides scientific leadership and technical oversight for all analytical operations supporting Pharmaceutical (Rx), Over‑the‑Counter (OTC), and Cosmetic products. This role ensures laboratory compliance with FDA 21 CFR Parts 210/211, ICH Q7‑Q10, USP/NF, and MoCRA standards. The QC Manager is accountable for analytical accuracy, data integrity, and inspection readiness across raw material, in‑process, finished product, and stability testing programs.

The position also drives the implementation of risk‑based testing, method lifecycle management, and data‑driven process improvements aligned with site and corporate Quality objectives.

Reporting to: Sr. Manager, Laboratory Services (QC)

Location: Johnson City, TN - 100% onsite

• Lead, mentor, and develop QC Supervisors, Chemists, and Analysts through structured training and technical coaching.
• Maintain current training matrices, instrument qualifications, and competency assessments.
• Support succession planning, performance evaluations, and individual development plans.
• Promote a culture of scientific excellence, ownership, and regulatory compliance.

• Lead and schedule all QC testing activities for raw materials, in‑process, finished goods, and stability samples.
• Ensure testing is performed per validated or verified methods (HPLC, GC, UV‑Vis, FTIR, ICP‑OES/MS, KF, TOC, pH, viscosity, etc.).
• Review and approve analytical data, chromatographic integrations, system suitability results, and trend analyses in accordance with ALCOA+ principles.
• Manage daily priorities to support batch release, stability commitments, and regulatory submissions.
• Support product investigations, method transfers, and laboratory deviation resolution.

• Maintain full compliance with cGMP, ICH, USP, EP, and MoCRA standards.
• Implement data‑integrity governance across Open Lab CDS, iStability, and electronic record systems (audit trails, user access, instrument logbooks).
• Ensure accuracy, contemporaneous documentation, and traceability for all analytical activities.
• Author and maintain laboratory SOPs, validation protocols, and technical reports.
• Act as QC representative during internal, corporate, and FDA inspections, ensuring readiness and timely response to observations.

• Oversee method validation, verification, and transfer activities following ICH Q2(R2).
• Evaluate method robustness, linearity, accuracy, precision, and detection limits; author and review validation summary reports.
• Manage raw material qualification and release under 21 CFR 211.84, approving supplier CoAs and verification results.
• Develop risk‑based sampling and testing plans for excipients, APIs, and packaging components.
• Maintain method equivalency and harmonization across contract and sister‑site laboratories.

• Administer the site stability program per ICH Q1A‑Q1F, including pull scheduling, testing, and reporting.
• Review trend charts, regression analyses, and control charts to identify OOT behavior before specification limits are breached.
• Author or review stability summary reports, OOS/OOT investigations, and risk assessments supporting expiry dating.
• Ensure timely reporting and electronic data archiving per retention policy.

• Oversee qualification, calibration, and PM of analytical instruments (HPLC/UPLC, GC, FTIR, ICP‑MS/OES, UV‑Vis, KF, balances, ovens).
• Maintain validated status of computerized systems under 21 CFR Part 11 and Annex 11.
• Support CAPEX planning, URS/FAT/SAT/IOQ/PQ execution, and implementation of new technologies (e.g., autosamplers, LIMS integration).
• Approve equipment change controls and ensure adherence to life‑cycle validation protocols.

• Own and manage OOS, OOT, Deviation, NCM, CAPA, and Change Control processes.
• Participate in Quality Review Boards, CAPA Effectiveness Reviews, and Risk Assessments (FMEA, 5‑Why, Fishbone).
• Develop and monitor Key Performance Indicators (KPIs) such as Right‑First‑Time,…