Director of QC

Asahi Kasei•Fremont, CA

11d•$155,000 - $200,000

About The Position

The QC leadership role oversees QC Operations. This role provides leadership across all QC functions, including Lab Operations, HPLC, Bioassay/ELISA, and Compendial and Raw Material testing, and is accountable for the development and optimization of QC laboratory IT systems. Partnering closely with the Senior Director of Quality Control, this position help support the establishing efficient, compliant, and high-performing laboratory operations with a strong quality and safety culture. This role ensures effective implementation of the Bionova Quality Management System, supports delivery of a state-of-the-art, automated laboratory in collaboration with Engineering, and works cross-functionally and with clients to ensure timely, reliable, and regulatory-compliant analytical results. This role requires deep expertise in Quality Control operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments.

Requirements

Bachelor of Science degree or equivalent in a scientific field
Minimum of 6 years of experience in analytical or quality control environments.
Minimum of 3 years of GMP Quality Control Laboratory experience including instrument qualification, microbiological testing, environmental monitoring, and method transfer
Expertise in data analysis, trend analysis, and statistical methods.
Excellent written and verbal communication skills to effectively document findings and present technical information
Working knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex etc.)
Effective organization and planning skills.
Demonstrated ability to deal with frequent changes, delays, or unexpected events
Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, SoftmaxPro or equivalent systems)
Effective interpersonal and communication skills. Communication at all management levels and all staff is required.

Responsibilities

Serve as a subject matter expert in one or more of the following areas: HPLC, compendial and raw material testing, bioassay/ELISA, and laboratory operations.
Lead, coach, and develop a team of analysts and junior managers to ensure high technical and performance standards.
Establish and maintain compliant laboratory operations aligned with Bionova quality standards and regulatory requirements, including the definition and monitoring of key performance indicators.
Implement Lean laboratory practices and drive continuous improvement to enhance efficiency and performance.
Review and interpret analytical data to identify trends, assess risk, and initiate appropriate corrective actions.
Lead investigations for deviations, including OOS, OOT, OOR, and OOE, performing root cause analysis and defining corrective and preventive actions.
Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein
Author and maintain analytical methods, validation and qualification documentation, and relevant laboratory procedures.
Support cross-functional QC activities by providing cross-trained resources to address urgent analytical needs.
Act as a subject matter expert during client audits and regulatory inspections, representing QC analytical and operational processes.