Senior Manager Quality Engineering

$170,000 - $180,000/Yr

Raise - Rockville, MD

Full-time - Senior

Rockville, MD

Insurance Carriers and Related Activities

About the position

The Senior Manager, Quality Engineering position is a full-time, permanent role focused on ensuring compliance and quality within a clinical-stage biopharmaceutical company. The role involves evaluating and improving quality systems, managing validation processes, and supporting facility qualifications to ensure adherence to regulatory standards. This position is ideal for individuals passionate about making a significant impact in the biopharmaceutical industry and who thrive in a dynamic work environment.

Responsibilities

• Evaluate the current status of VMP, including general CQV, CSV and EMPQ to identify gaps, propose mitigation and initiate remediation.
• Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.
• Support facility qualification / commissioning and operations / preventative maintenance program.
• Support and manage master equipment file.
• Implement qualification and validation life cycle for both software and equipment (IQ, OQ, PQ).
• Support the site quality system management with measurement and control strategies.
• Manage the risk assessment process for qualification and validation.
• Review technical/investigation reports as appropriate.
• Write, review, and approve proposed changes to systems and procedures, as appropriate.
• Write, review, and approve protocols and summary reports.
• Perform other duties and tasks as assigned.

Requirements

• Bachelor's degree in technical discipline (Computer Science/ Industrial Engineering or similar).
• Minimum of 7 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product).
• Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10).
• Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.
• Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product).
• Strong knowledge of GMP, GAMP, SOPs, and quality systems.
• Experience with internal and external audit principles.
• Strong knowledge of change control practices/strategies.
• Proficient in MS Word, Excel, PowerPoint, and other applications.
• Ability to communicate and work independently with scientific/technical personnel.
• Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude.

Nice-to-haves

• Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred.

Benefits

• Competitive salary range of $170k to $180k.
• Bonus opportunities.
• Comprehensive benefits package.
• On-site work environment in Rockville, MD.