Associate Director of QC / HPLC

Associate Director of

QC / HPLC

The QC leadership role oversees QC Operations. This role provides leadership across all QC functions with focus HPLC & Capillary 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 GMP operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments.

Position Responsibilities:

Serve as an HPLC subject matter expert and drive improvement of HPLC workflows and our Empower based CDS. 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.

Working Conditions:

This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.

Qualifications:

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. Strong working knowledge of HPLC and CE analytics with expertise in method development and GMP validation. Experience in designing CDS workflows (data review, audit trails, design of workflows, custom fields…) 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, or equivalent systems) Effective interpersonal and communication skills. Communication at all management levels and all staff is required.

Compensation Range:

The base compensation range for this role is between $155,000 and $200,000. However, the actual compensation may vary depending on your experience and qualifications.

Health Benefits and Program:

Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance

Life Insurance and Disability Program:

100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. #LI-MG1