Job Description

Role Title: Quality Control Manager, Analytical

Location: Vacaville

Department: QC

Reports to: Director of QC

FLSA- Exempt

Salary Range - $110K-$140K

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

ROLE SUMMARY

The Quality Control Manager will be an integral part of the team implementing and maintaining cGMP compliant Laboratory systems. They will lead the quality control function including cGMP analytical testing, validation, and routine QC laboratory operations. This individual will need to build systems/processes and organize resources to establish and achieve product release cycle time targets and meet project due dates/deliverables in a highly collaborative and cross-functional environment for both in-house and CDMO products. The ideal candidate will apply strong leadership and cGMP experience, ensure compliant operations and documentation, foster open communication, and pursue data-driven approaches.

ROLE RESPONSIBILITIES

• Work within the Quality team and interface with key stakeholders to establish and maintain cGMP compliant quality control operations, including collaboration with Validation and Analytical Development teams on new QC laboratory processes as needed (programming, equipment purchase/qualification, process documentation).
• Provide technical and strategic functional oversight, including resource/operational management for all QC areas (physicochemical, biological, etc.)
• Accountable for execution of quality control testing and supportive processes including sample and inventory management, scheduling, documentation, compliance review, results reporting (CoA), and scientific interpretation of data / method performance to ensure high quality data and control of methods.
• Responsible for development, planning, approval, and execution of project plans supporting clinical and commercial QC testing and release, investigations, reference standards, and stability studies. Organize and lead meetings regarding project status, including project timelines, deviations, potential issues and corrective action resolutions.
• Function as analytical subject matter expert (SME) and collaborate closely with key stakeholders including process development, quality control, manufacturing, quality, regulatory and clinical teams to define and execute comprehensive technical development strategies.
• Establish and implement processes to enable effective collaboration with internal and CRO/CDMO business partners to ensure efficiency, high-quality results, and to meet required timelines.
• Method transfer and/or co-validation in collaboration with analytical development, analytical technologies, and management of any outsourced cGMP testing supporting lot release/stability.
• Responsible for review and approval of analytical test record forms, investigations (including OOS & OOT), QC related audit trails, stability data, paper and/or electronic documentation associated with QC laboratory operations, data integrity and quality event management (deviations, investigations, change control).
• Responsible for ensuring proper change control processes (e.g. impact assessments, preapprovals, interim reports, and final approvals) are maintained throughout project execution.
• Lead preparation for regulatory inspections from Health Authority agencies such as the FDA, EMA, TGA, and other global health authorities.
• Serve as the primary point of contact during regulatory audits, facilitating smooth communication and addressing any questions or concerns raised by inspectors.
• Coordinate responses to regulatory findings and health authority observations, ensuring corrective actions and preventive measures are implemented and documented effectively.
• Guide and work with others to identify opportunities for continuous improvement and implement/maintain solutions.
• Provide strong leadership in establishing a quality culture and shared accountability.
• Ensure GMP compliance is built into the design and implementation of processes and systems, including tracking metrics to monitor and improve performance.

SKILLS

• Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
• Sound knowledge of cGMPs
• Ability to interpret and relate Quality standards for implementation and review
• Strong understanding of regulatory requirements, especially FDA 21 CFR, EMA, and ICH guidelines.
• Ability to make sound decisions about scheduling, allocation of resources, and managing Priorities
• Ability to communicate issues, ideas and results clearly and professionally in a comprehensive and concise manner both in writing and verbally. Ability to explain complex issues and concepts with simplicity to a broad audience.
• Flexibility in problem solving, providing direction and work hours to meet business objectives
• Demonstrate strong leadership skills through past work history with direct supervisory role preferred.
• Identifies key issues in complex situations and analyzes problems and makes sound decisions.
• Technically knowledgeable regarding analytical methods, validation, transfer, method monitoring and regulatory/quality system requirements.
• Excellent written, verbal, and communication skills.
• Committed to establishing a collective quality culture, including detailed record keeping, active collaboration and advocating for continuous improvement.

MANAGER QUALIFICATIONS

• B. S./B. A. in Science/Related Field (major in biology-biochemistry-chemistry). 8+ years of relevant cGMP laboratory, people management, and Health Authority audit experience is required
• MS Degree in Science/Related Field (major in biology-biochemistry-chemistry). 6+ years of relevant cGMP laboratory and people management, and Health Authority audit experience is required
• PhD in Science/Related Field (major in biology-biochemistry-chemistry). 3+ years of relevant cGMP laboratory and people management, and Health Authority audit experience is required

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