QA Program Manager - cGMP & Compliance Leader

Bimeda, Inc.; Pomona (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) plan

Paid time off

Life insurance

Employee assistance program

Job summary

Bimeda is seeking a QA Manager in Pomona, CA to lead quality systems and regulatory readiness in an in-office setting. The role oversees QA investigations, audits, and continuous improvement while managing a team of QA professionals and collaborating cross-functionally.

Responsibilities include ensuring compliance with cGMP/GDP, coordinating CAPAs, and driving metrics-driven improvements. Leadership and strong communication across levels are essential for success.

Qualifications

• 5–7 years of experience in a regulated pharmaceutical industry, including Quality Assurance and Quality Control.
• Minimum 2–3 years in a leadership role.
• Strong knowledge of cGMP, Quality Systems, Drug Regulatory Affairs, and stability protocols.
• Proven leadership and communication skills across all organizational levels.
• Ability to manage competing priorities in a fast-paced environment.

Responsibilities

• Ensure ongoing compliance with local, national, and international standards and legislation.
• Lead quality systems and monitoring activities to support product release and regulatory compliance.
• Liaise with customers to manage quality-related requests, corrective actions, and specifications.
• Oversee the quality process related to product shipment and delivery, ensuring timelines and KPIs are met.
• Lead and support internal audits, Health Authority inspections, and customer audits.
• Ensure CAPAs are tracked, implemented, and remediated in a timely manner.
• Manage investigations into batch discrepancies, non-conformances, and out-of-specification events; ensure root cause analysis and corrective actions are completed.
• Ensure product quality complaints are investigated, trended, and resolved in collaboration with relevant departments.
• Monitor quality system performance through KPIs and publish metrics with recommendations for improvement.
• Provide direction to direct reports regarding priorities, trials, audits, new projects, and client visits.
• Develop and implement project management strategies for quality initiatives.
• Achieve results through direct reports by setting goals, coaching, reviewing performance, and supporting development.
• Ensure cross-training of team members to support operations.
• Accomplish financial objectives by forecasting requirements, preparing budgets, analyzing variances, and initiating corrective actions.
• Lead by example and foster collaboration across internal teams and external stakeholders.

Skills

Leadership

Quality Assurance

cGMP

Quality Systems

Audits

Cross-functional collaboration

Regulatory affairs

Stability protocols

Communication

Prioritization

Education

MS degree or MBA

Job description

Bimeda is seeking a QA Manager in Pomona, CA to lead quality systems and regulatory readiness in an in-office setting. The role oversees QA investigations, audits, and continuous improvement while managing a team of QA professionals and collaborating cross-functionally.

Responsibilities include ensuring compliance with cGMP/GDP, coordinating CAPAs, and driving metrics-driven improvements. Leadership and strong communication across levels are essential for success.