Quality Assurance Supervisor

GeminiBio LLC.; Sacramento (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

GeminiBio LLC. is seeking a QA Supervisor in West Sacramento, CA to lead QA Operations and Scientific Support, ensuring products and processes meet regulatory and customer requirements. The role oversees release decisions, quality records review, and improvement initiatives.

You will mentor QA and Scientific Support staff, drive audit readiness, manage deviations and CAPA, and report quality metrics to management to sustain compliance and continuous improvement.

Qualifications

• Bachelor’s degree in science; 5+ years in cGMP QA; 2+ years leadership experience.
• Deep knowledge of GMP regulations and quality systems.
• Experience with supplier qualification, deviations, and CAPA processes.

Responsibilities

• QA Operations & Scientific Support oversight to ensure timely quality activities.
• Perform product release activities and ensure documentation is complete and compliant.
• Oversee Deviations, OOS, NMRs, and other Quality Events throughout their lifecycle.
• Coordinate and support customer and regulatory audits and inspections.
• Prepare quality metrics and reports for management reviews.

Skills

Leadership

Quality systems

Audits

GMP

Regulatory knowledge

Education

Bachelor’s degree in science

5+ years cGMP QA

2+ years leadership

Job description

Founded in 1985, GeminiBio serves the global biotechnology industry, from basic research to commercial production, with a focus on helping our customers accelerate the development of life-enhancing biotherapeutics.

The company focuses on producing cell culture products, instruments, and solutions that help customers streamline their discovery, development, and production processes, and by making custom cGMP bioprocess liquids that radically simplify customers' manufacturing workflows – regardless of batch size.

Located in West Sacramento, California, GeminiBio has two manufacturing facilities, comprising a total of 57,000 square feet. To meet the stringent needs of biotechnology research and production customers, the company's cell culture sera and bioprocess liquid manufacturing facilities are segregated between animal origin-free cGMP manufacturing and animal component cGMP manufacturing. GeminiBio is an ISO 13485 certified, FDA registered Class 1 Medical Device Manufacturer, aligned with 21 CFR Part 820.

Position Summary

The QA Supervisor is responsible for overseeing Quality Operations and Scientific Support activities to ensure products, processes, and quality systems comply with regulatory, customer, and company requirements. This role provides leadership and guidance to quality personnel, supports product release decisions, and ensures the timely review and approval of quality records, investigations, and assessments. The position plays a key role in audit and inspection readiness by coordinating audits, supporting regulatory inspections, and driving the resolution of compliance issues. Additionally, the QA Supervisor develops team members, monitors quality performance metrics, and communicates quality risks, trends, and improvement opportunities to management to support continuous improvement and operational excellence.

Key Responsibilities

QA Operations & Scientific Support Oversight

• Supervise and provide guidance to QA Operations and Scientific Support personnel to ensure timely execution of quality activities.
• Review and approve quality records, investigations, assessments, and documentation for accuracy, completeness, and compliance.
• Provide escalation support for quality issues, compliance risks, and product disposition decisions.

Product Release & Quality Review

• Perform product release activities for manufactured, OEM, repackaged products.
• Ensure batch records, completed records, and supporting documentation are reviewed and maintained in accordance with applicable requirements.
• Support decision-making related to product disposition and quality risk assessments.

Quality Systems Management

• Oversee Deviations, Out of Specification (OOS), Nonconforming Material Reports (NMRs), and other Quality Events throughout their lifecycle.
• Ensure customer complaints are investigated, documented, and resolved in a timely manner.
• Provide oversight of supplier qualifications, reassessment, change notification reviews, and supplier quality activities.
• Support continuous improvement initiatives that strengthen quality system effectiveness.

Audit and Inspection Readiness

• Coordinate and support customer audits, internal audits, supplier audits and regulatory inspections.
• Review audit responses and ensure timely completion of corrective actions.
• Promote inspection readiness through routine monitoring of quality system compliance.
• Manage workload, priorities, and resource allocation within the QA team and Scientific Support team.
• Coach, mentor, and develop QA team and Scientific Support team.
• Conduct performance evaluations and establish development plans for team members.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

Management Reporting

• Prepare and present quality metrics, quality performance indicators, and compliance updates to management.
• Participate in Quality Management Review activities and provide recommendations for quality system improvements.
• Communicate significant quality issues, risks, and improvement opportunities to senior leadership.

Core Competencies

• Customer Centric
• Consistently aware of how work product impacts customer value and experience and works with intensity to optimize customer value and experience. Able to identify barriers and inefficiencies impacting customer value.
• Effective Teamwork
• Keen ability to collaborate with a diverse set of colleagues – often under pressure – to accomplish business objectives and deliver customer value. Able to identify – and correct – the issues degrading the success of teams.
• Personal Leadership
• Consistently delivers high-quality individual results, and when problems are encountered, able to be self-reflective and identify new ways of working to accomplish individual objectives. Strong level of personal accountability. Invests time and energy into professional development. Routinely takes the initiative to solve challenges and capitalize on business opportunities.
• Planning and Organizing
• Able to clearly identify the work that needs to be done and the order in which the work needs to be completed to generate the desired result. Consistently able to foresee challenges and barriers to success and then effectively develops – and implements – actions to accomplish objectives.
• Effective Communications
• Able to organize thoughts to communicate to colleagues concisely and accurately and, as needed, management. Oral and written communications are professional and appropriate for the setting and the audience.
• Expert at building, organizing, and managing diverse teams to accomplish challenging objectives – on time and under budget. Takes proactive steps to design and implement systems to effectively communicate team vision/ mission and cultivates the motivational atmosphere required to maximize the performance of everyone within the team.
• Execution Management
• Expert at deploying tools and processes to bring clarity – and accountability – to the complex actions and deliverables required to accomplish the objective. Ruthlessly manages project deliverables, timelines, and results. Holds individuals and teams accountable to deliver on commitments.
• Performance Management
• Sets objectives and metrics with individuals and teams to ensure clarity regarding the desired outcomes and how success will be determined. Skillful in coaching – and supporting – individuals and teams. Able to quickly identify performance gaps, assess root cases, and implement corrective actions. Unsatisfied with poor performance and able to rigorously address performance barriers.
• Business Acumen
• Keen ability to understand how a business works, how the business delivers value to customers, how it makes money, and how strategies and decisions impact financial, operational, and sales results. Able to quickly understand the nuances and trade-offs associated with critical business issues, challenges, and opportunities, and make decisions that generate the greatest benefit to the business – and stakeholders.

Company Values

• Integrity
• Doing the right thing – the first time. Honoring and keeping commitments.
• Intensity
• Working with speed and focus to deliver the highest quality results – on time.
• Involvement
• Embracing unique perspectives and treating others with dignity and respect.
• Biased to improve processes and products to better serve customers and improve workflows.

Required Skills and Experience

• Bachelor’s degree in science and 5+ years working in a cGMP Quality Management System with at least 2 years leadership experience
• Knowledge and understanding of ISO quality system standards (either ISO 9001 or ISO 13485)
• Independent problem solving and root cause analysis skills
• Skilled with auditing principles
• Self-motivated who can work in a multidisciplinary team
• Excellent at multitasking and prioritization of tasks
• Strong interpersonal skills to collaborate with other cross-functional partners
• Aptitude to work in a complex and rapidly growing company
• Ability to develop and deliver communications to provide timely information for action
• Must be highly accurate and detail-oriented
• Knowledge of Microsoft Office products
• Excellent oral and written communication skills