SR. Quality Control Manager

Position Summary:
The Senior Quality Control Manager serves as the on-site quality control leader at the Biovation manufacturing facility, overseeing all QC activities related to raw materials, in-process production, and finished goods testing.

This role ensures that products consistently meet internal specifications, cGMP requirements, and regulatory expectations under 21 CFR 111 and 117. The Senior Quality Manager provides day-to-day leadership for the QC team, partners closely with Operations to resolve production issues, and acts as the site-level quality authority for decision-making related to product quality and compliance.

Job Duties & Responsibilities:

Leadership & Oversight

• Lead, mentor, and develop Quality Control staff to ensure consistent execution of sampling, inspection, and testing procedures.
• Serve as the on-site quality decision-maker for in-process production issues and material release recommendations.
• Build a strong, proactive quality culture that emphasizes accountability, continuous learning, and ownership.
• Represent the Quality Control Department at leadership meetings and communicate QC trends and findings.

Operational Quality Control

• Oversee raw material, in-process, and finished-product testing programs in compliance with approved specifications and test methods.
• Manage the translation of third-party laboratory results, in-house testing, and any supplemental information into a Biovation Certificate of Analysis (COA) for product approval/release.
• Verify environmental monitoring, calibration, and maintenance of QC instruments.
• Partner with Production to ensure corrective actions for line or blend deviations are implemented effectively.
• Oversee re-qualification of expired raw materials according to GMPs.

Compliance & Coordination

• Ensure all QC activities are performed in accordance with cGMP, FDA, and company SOP requirements.
• Responsible for launching and investigating non-conformances and associated CAPAs; oversee and support OOS investigations.
• Collaborate with QA on deviation investigations, complaint assessments, and CAPA follow-up.
• Support internal and external audits, providing QC documentation and responses as needed.
• Participate in mock recalls, rework evaluations, and material review processes.
• Assist in maintaining and updating QC-related SOPs and specifications.

Continuous Improvement & Metrics

• Identify opportunities to streamline QC processes and testing efficiency.
• Track and report on key QC metrics (e.g., in-process defects, OOS rate, turnaround time) to leadership.
• Support cross-functional training and operational improvements that enhance first-pass yield and reduce waste.
• Participate in continuous improvement plans, including processes and guidelines to assist in streamlining regulatory systems and operations.

Qualifications:

• Bachelor’s degree in a scientific discipline (Chemistry, Biology, Food Science, or related field).
• Minimum 5–7 years of experience in Quality Control, preferably within dietary supplement, food, or pharmaceutical manufacturing.
• Deep understanding of cGMP and regulatory standards under 21 CFR 111 and 117.
• Demonstrated experience leading QC teams in a manufacturing environment.
• Strong analytical and decision-making skills with a hands-on approach.
• Familiarity with ERP and electronic quality systems preferred.
• Regulatory and Certification Audit Experience (NSF, SQF, FDA, Customer) strongly preferred.
• Effective communication skills both verbally and in writing.