Quality Control Manager

Revance-posted about 1 month ago
Full-time • Manager
Onsite • Johnson City, TN
101-250 employees
Chemical Manufacturing
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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.

  • 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 OpenLab 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, CAPA timeliness, and laboratory cycle time.
  • Lead continuous-improvement initiatives focused on method robustness, cycle-time reduction, and Cost of Quality (CoQ) optimization.
  • 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.
  • Bachelor's degree & 7+ years' directly related experience.
  • Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
  • Advanced degree.
  • 7-10 years in a cGMP Qc laboratory; minimum 3-5 years in management or supervision.
  • Hands-on experience in method validation, stability programs, analytical troubleshooting, and regulatory audits.
  • Proven knowledge of FDA, ICH, USP/NF, and MoCRA regulatory frameworks.
  • Competitive Compensation including base salary and annual performance bonus.
  • Paid time off, company holidays, and floating holidays that can be used whenever you choose.
  • Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more.
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