Sr Ops Quality Eng

Paladin Labs Inc.; Raleigh (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

Paladin Labs Inc. is hiring a Senior Quality Engineer in Raleigh, North Carolina. In this role, you will develop and implement SOPs while supporting regulatory compliance across a cGMP manufacturing facility.

The successful candidate will have at least 5 years of experience in quality assurance within pharmaceutical manufacturing, strong communication skills, and a deep understanding of relevant regulations. Join us to ensure the highest quality products reach our customers.

Qualifications

• Minimum of 5 years' experience in QA/pharmaceutical manufacturing.
• Knowledge of ICH Guidelines, FDA, EMA regulations.
• Strong technical, oral, and written communication skills.

Responsibilities

• Interpret and apply regulatory requirements.
• Develop, implement, and maintain SOPs.
• Provide Process/Quality Engineering support.

Skills

Quality assurance

Regulatory inspections

Statistical process control

Project management

Problem-solving

Education

B.S. degree in Engineering, Science, or a related field

Tools

SPC

FMEA

Six Sigma tools

Job description

Job Summary

The Senior Quality Engineer will interpret regulations and quality systems, develop and implement standard operating procedures (SOPs) and policies, and provide process and quality engineering support throughout a cGMP manufacturing facility. The role includes statistical and process support for continuous improvement to ensure delivery of the highest quality product to customers.

Responsibilities

• Interpret and apply applicable regulatory requirements and quality systems.
• Develop, implement, and maintain SOPs and quality policies.
• Provide Process/Quality Engineering support to all facility areas to ensure high‑quality product delivery.
• Apply statistical tools to analyze data, identify root causes, and develop corrective actions for moderate to difficult scope and complexity.
• Support regulatory filings, including annual product reviews, process controls, change controls, validations, product complaints, audits, internal audits, supplier quality, OOS, and CAPA.
• Lead and manage the site Internal Audit program.
• Guide and train Quality Department personnel on applicable Quality Systems.
• Lead compliance efforts and respond to customer inquiries.
• Prepare Annual Product Reviews, Management Reviews, and monthly metrics reports.
• Drive quality system improvements and benchmark best practices across sites.
• Provide validation guidance for computer systems, production processes, and laboratory equipment.
• Lead continuous improvement activities such as kaizen and statistical process control initiatives.
• Analyze trends, conduct investigations, and implement corrective/preventive action projects.
• Lead or participate in risk analysis activities (FMEA) for changes to production or design processes.
• Use process mapping tools to define critical control points and recommend risk‑reduction alternatives.
• Oversee cross‑functional complaint investigation teams, generate final reports, and document investigation plans.
• Serve as a subject‑matter expert for regulatory and customer audits.
• Conduct new employee orientation and provide supplier quality oversight, including technical support and corrective action plan management.

Qualifications

• B.S. degree in Engineering, Science, or a related field.
• Minimum of 5 years' experience in QA/pharmaceutical manufacturing.
• Knowledge of ICH Guidelines (Q7, Q8, Q9, Q10), FDA, EMA, USP, EP, and JP regulations.
• Direct experience with regulatory inspections.
• Strong technical, oral, and written communication skills.
• Proficiency in English (reading, writing, speaking).
• Knowledge of Six Sigma tools or certification.
• Project management, problem‑solving, team‑building, negotiation, facilitation, and presentation skills.
• Ability to manage multiple projects and work independently.
• Strong computer and statistical skills (SPC, DOE, FMEA, Lean).
• Preferred certifications: CQE, CQA.

Important Information

Work conditions include normal office and meeting room settings, periodic plant assignments, exposure to typical chemical emissions, and occasional travel. Personal Protective Equipment (PPE) may be required as directed by EH&S and safety guidelines.

DISCLAIMER: The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and we provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.