Purpose and Scope

The QA Operations Manager is responsible for managing Quality Assurance support for manufacturing operations, focusing on aseptic processing, terminal sterilized products, sterility assurance, and contamination control. This role ensures compliance with current Good Manufacturing Practices (cGMP) following 21 CFR 210/211, internal procedures, and regulatory requirements while driving continuous product quality and operational excellence improvement. The QA Operations Manager also serves as the quality representative on cross-functional project teams and collaborates with internal and external alliance partners to support the consistent delivery of safe, high-quality pharmaceutical products.

Essential Duties & Responsibilities

Provide quality oversight for all sterile manufacturing operations, including aseptic processing, terminally sterilized processes, and related support areas.

Manage the QA team to provide coverage and decision-making support across a variable radiopharmaceutical manufacturing schedule, including off-shift and potential weekend operations as needed.

Ensure the integrity of sterile product manufacturing through robust sterility assurance practices.

Build and oversee the facility electronic Quality Management System (eQMS) for the site.

Manage QA review and approval of cGMP documentation, including procedures, protocols, deviations, out of specifications, CAPAs and change controls.

Act as a subject matter expert (SME) during regulatory inspections and internal/external audits for quality assurance operations.

Lead, coach, and develop quality team members to maintain a high-performing, quality-focused, and engaged workforce, to maintain compliance and foster continuous improvement.

Monitor and report on key quality performance metrics to monitor performance and drive continuous improvement initiatives including management of an internal audit program.

Collaborate with cross-functional departments (Manufacturing, QC, Engineering, Safety, Regulatory, etc.) to resolve quality-related issues and support new products and product lifecycle management.

Serve as a QA representative on cross-functional project teams to ensure quality requirements are built into new processes, equipment, and products from the outset.

Promote a proactive quality culture focused on patient safety, product quality, and regulatory compliance.

Knowledge, Skills & Abilities

Strong knowledge of cGMP regulations (21 CFR Parts 210/211), FDA Guidance for Aseptic Processing.

Strong technical understanding of aseptic processing, sterilization methods, cleanroom classifications, and contamination control practices

Understanding of contamination control practices and sterility assurance principles preferred. Experience with quality systems, deviation/investigation management, change control, and CAPA.

Excellent written and verbal communication skills; capable of presenting quality topics to regulators and senior leadership.

Ability to analyze complex problems, identify root causes, and drive corrective actions.

Strong leadership, interpersonal, organizational skills and the ability to influence cross-functional teams.

Education & Experience

Bachelor's degree in scientific discipline preferred.

Five or more years' experience in the pharmaceutical industry (210/211) in a quality role required.

5 years in sterile injectables preferred.

Four or more years' previous experience in a supervisory role required.

PharmaLogic offers a competitive compensation package and superior benefits.

Come join our winning team and begin a fulfilling career with us by applying today.

Benefits Include:

• 401(k) retirement benefit program
• Medical
• Dental care
• Disability insurance
• Employee assistance program
• Extended health care
• Life insurance
• On-site parking
• Paid time off
• Vision care

9 am to 5 pm
40 hours per week