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

Responsibilities/Essential Duties:

Leadership & Staff Development

• 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.

Laboratory Operations & Technical Oversight

• 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.

Regulatory Compliance & Data Integrity

• 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.

Method & Raw Material Management

• 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.

Stability & Product Trending

• 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.

Equipment & Analytical Technology

• 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.

Quality Systems & Continuous Improvement

• 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.

Basic Qualifications:

• Bachelor’s degree & 7+ years’ directly related experience.

Preferred Qualifications:

• 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.

Company Summary:

Crown is a proud member of the Revance Portfolio of skincare offerings. Revance is a fast-growing global aesthetics and skincare company focused on providing innovative aesthetics and market-leading skincare offerings throughout every stage of life. With a differentiated portfolio of products spanning 60 countries, Revance meets the evolving needs of patients and consumers worldwide through continued innovation and commercialization of new products and treatments.
What Revance invests in you:

• Competitive Compensation including base salary and annual performance bonus.
• Flexible PTO, holidays, and parental leave.
• Generous healthcare benefits, HSA match, 401k match, employer paid life and disability insurance, pet insurance, wellness discounts and much more!

This section of the job description is required by the American with Disability Act (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a “qualified individual with a disability” in all aspects of the employment relationship. A “qualified individual with a disability” is “an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job.”

Revance is an Equal Opportunity employer. All qualified applicants will receive consideration for employment based on merit, without regard to race, color, religion, sex, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.