Manager, QA Floor Operations (Sterile/Aseptic Pharma Experience Req.)

Manager, QA Floor Operations

About Penn Life Sciences

Penn Life Sciences (PLS) is a rapidly growing pharmaceutical manufacturer dedicated to producing high-quality sterile generic drug products. Headquartered in Langhorne, Pennsylvania, PLS is developing a modern, U.S.-based sterile manufacturing facility designed to meet the highest FDA and global cGMP standards. Our mission is to strengthen domestic pharmaceutical supply, enhance patient access to affordable, life-saving medications, and uphold the values of integrity, innovation, and scientific excellence in everything we do.

What You’ll Do

The Manager, QA Floor Operations provides strategic and hands-on Quality Assurance leadership with continuous, real-time oversight of sterile manufacturing and packaging operations. This role serves as the primary Quality Assurance authority on the manufacturing floor, ensuring compliant execution of aseptic processing, accurate documentation, effective quality decision-making, and sustained inspection readiness. The position leads on-floor QA Operations activities, supports timely resolution of quality issues during live manufacturing, and acts as a critical liaison between Manufacturing, Quality Control, Engineering, and Quality leadership to maintain alignment, escalation, and regulatory compliance.

Key Responsibilities

• Lead and oversee daily QA Operations activities supporting sterile injectable manufacturing and packaging, including aseptic processing, filling, lyophilization (if applicable), and visual inspection support.
• Provide continuous, real-time QA presence on the manufacturing floor to support compliant execution of batch operations, aseptic techniques, and critical process controls.
• Review and approve line clearances, room clearances, equipment release, and product changeovers in accordance with approved procedures and aseptic requirements.
• Review executed batch production records, batch packaging records, and associated GMP documentation for accuracy, completeness, and compliance prior to disposition.
• Exercise quality decision-making authority during manufacturing operations, including assessment of deviations, interventions, procedural discrepancies, and aseptic risks.
• Oversee in-process inspections and on-floor verification activities to ensure adherence to approved procedures, environmental controls, and sterile manufacturing standards.
• Initiate, review, and approve deviation investigations, root cause analyses, and CAPA related to manufacturing, aseptic processing, and on-floor activities.

What We’re Looking For

Experience:

• Minimum of 7–10 years of progressive Quality Assurance experience in a cGMP-regulated sterile injectable pharmaceutical manufacturing environment.
• Demonstrated experience providing on-floor QA oversight of aseptic manufacturing operations.
• Prior experience leading or managing QA Operations or QA floor teams in a sterile environment.
• Experience supporting regulatory inspections (FDA and client audits) in a sterile facility strongly preferred.

Education:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Biology, Engineering, or a related scientific discipline required.
• A combination of education and relevant experience will be considered.

Skills & Knowledge:

• Advanced working knowledge of cGMP regulations applicable to sterile injectable manufacturing (21 CFR Parts 210/211).
• Strong understanding of aseptic processing principles, sterility assurance, environmental monitoring, and contamination control strategies.
• Demonstrated ability to provide decisive, real-time QA judgment during live manufacturing operations.
• Experience supporting deviations, investigations, CAPA, batch disposition, and inspection readiness.
• Strong understanding of data integrity principles (ALCOA+) and good documentation practices.
• Proven leadership ability in fast-paced, regulated manufacturing environments.
• Proficiency with Microsoft Office applications and electronic quality management systems (eQMS).

What We Offer

• Competitive compensation with annual performance bonus eligibility
• Annual merit-based pay increases
• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed
• Paid Time Off
• 10 paid company holidays
• Comprehensive medical, dental, vision, and life insurance coverage
• Professional development reimbursement
• Career growth opportunities

Schedule

• Full-time, on-site 1st-shift position
• Schedule aligned to manufacturing operations; flexibility required to support aseptic processing activities and on-floor QA coverage