Manager, Commercial Quality Assurance

📋 Description

• Assist in the development, enhancement, and oversight of Quality Assurance (QA) programs, policies, and procedures to maintain compliance with current Good Manufacturing Practices (cGMP).

• Act as the QA liaison for designated vendors, contract facilities, or collaborative development partners.

• Conduct QA assessments of manufacturing records, validation documentation, batch records, and submissions to regulatory bodies.

• Lead audits of vendors to ensure adherence to cGMP standards.

• Offer insights on vendor Quality System occurrences, including change controls, deviations, investigations, out-of-specifications, and Corrective and Preventive Actions (CAPAs).

⛳️ Requirements

• Bachelor's degree in a relevant scientific field.

• A minimum of five (5) years of experience in Quality Systems and Quality Assurance processes, encompassing development and documentation.

• At least three (3) years of experience managing QA projects, including directing and organizing personnel to meet critical deadlines.

• Familiarity with commercial drug manufacturing and manufacturing process validation; knowledge of federal laws and regulations impacting the pharmaceutical sector.

• Experience overseeing contract manufacturers with direct operational QA responsibilities.

🏝️ Benefits

• HIGHLY COMPETITIVE SALARIES

• ANNUAL PERFORMANCE/MERIT REVIEWS

• ANNUAL PERFORMANCE BONUSES

• EQUITY

• SPECIAL RECOGNITION

• FULLY REMOTE WORK ENVIRONMENT

• REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off

• HOLIDAYS – In 2026 we will observe 14 holidays

• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary

• HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal

• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC

• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans

• LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans

• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More