Quality Control Manager

Position Overview

We are small pharmaceutical manufacturing company supporting commercial production of finished dosage forms (mainly oral films and transdermal/topical patches). We are seeking an experienced, compliance-driven Quality Control (QC) Manager to lead and manage all QC laboratory operations with authority, discipline, and operational efficiency.

This role leads and ensures compliance with US FDA 21 CFR Parts 210/211, ICH guidelines, USP/EP/JP requirements, and other applicable global regulations. The QC Manager ensures timely testing, product release support, stability program management, data integrity, 21CFR Part11 compliance and regulatory inspection readiness.

The QC Manager ensures laboratory compliance, data integrity, timely testing, method validation/verification, stability studies, and continuous improvement of quality systems in alignment with GMP standards.

Responsibilities and Duties

1. Laboratory Management

• Lead and oversee day-to-day QC laboratory operations (chemical, analytical, and microbiological where applicable).
• Manage external/contract laboratories where applicable.
• Oversee testing of raw materials, in-process samples, finished products, stability samples, and packaging components.
• Review and approve analytical data and laboratory records.
• Ensure compliance with specifications, SOPs, and regulatory requirements.

2. GMP & Regulatory Compliance

• Ensure laboratory compliance with:
• 21 CFR Part 211 (cGMP)
• Applicable ICH guidelines
• USP / EP / JP requirements as needed
• Maintain, lead and support regulatory inspections (FDA, EMA, MHRA, etc.).
• Ensure ALCOA+ principles and 21CFR Part 11 for data integrity and electronic data management.
• Manage OOS, OOT, deviations, investigations, and CAPAs.
• Ensure proper qualification and calibration, preventive maintenance of laboratory equipment (IQ/OQ/PQ)

3. Method Validation, Verification & Transfer

• Oversee analytical method validation, verification, and transfer activities per ICH Q2(R1/R2).
• Creation, Review and approve validation protocols and reports.
• Ensure methods remain scientifically sound and compliant throughout their lifecycle.

4. Batch Release Support

• Provide QC approval for batch disposition.
• Ensure timely completion of release testing to support production schedules.
• Support QA during final product release decision.
• Participate in change control assessments impacting product quality.

5. Stability Program Management

• Establish and manage stability programs per ICH Q1 guidelines.
• Review stability data and trends.
• Ensure timely stability reporting for regulatory submissions (NDA/ANDA/DMF).

6. Documentation & Quality Systems

• Approve QC SOPs, specifications, test methods, and laboratory procedures.
• Ensure controlled documentation practices.
• Participate in change control processes.
• Maintain laboratory metrics and trending reports.

7. Leadership and Team Management

• Provide strong leadership and clear direction to QC staff.
• Establish measurable KPIs (e.g., OOS rate, right-first-time testing, release cycle time).
• Effectively allocate resources and manage workload priorities.
• Develop and mentor staff to ensure high technical competency and GMP compliance.
• Foster a culture of accountability, discipline, and continuous improvement.
• Exercise authority to halt testing or escalate issues where compliance risks exist.

Qualifications

Education

• Bachelor’s or Master’s degree in:
• Chemistry
• Pharmaceutical Sciences
• Microbiology or
• Related scientific discipline

Experience

• 8–12 years in pharmaceutical QC laboratory.
• Minimum 4–5 years in supervisory/managerial role.
• Experience in NDA/ANDA regulated environment preferred.
• Proven experience leading regulatory inspections and managing post-inspection responses.

Technical Skills

• Strong knowledge of:
• HPLC, GC, UV, FTIR, Dissolution, KF, etc.
• Microbiological testing (if applicable)
• Stability studies
• Experience with:
• LIMS (preferable)
• Chromatography Data Systems (e.g., Empower)
• Understanding of:
• OOS/OOT investigations
• Data integrity compliance
• Regulatory inspection management

Core Competencies

Strong knowledge of:

• Assay & impurity profiling
• Dissolution method development & troubleshooting
• Content uniformity
• Cleaning validation testing

Deep understanding of:

• Stability study design
• Compendial compliance
• Data integrity requirements
• OOS investigation procedures

Authority & Accountability

• Authority to approve or reject materials and finished product test results.
• Authority to halt testing in case of compliance concerns.
• Accountable for laboratory compliance status and inspection outcomes.
• Responsible for maintaining a state of continuous inspection readiness.

Job Type: Full-time

Pay: $100,000.00 - $125,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person