QA/ QC Director

Biosimilar Sciences PR LLC

4h•Onsite

About The Position

OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies. OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory and systems capabilities and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow. The Director of Quality Assurance / Quality Control (QA/QC Director) is responsible for the strategic leadership, operational oversight, and performance management of both QA and QC functions supporting aseptic manufacturing, analytical and microbiology laboratories, and CDMO client programs. This role ensures compliance with FDA cGMP requirements (21 CFR Parts 210, 211, and Part 11) while supporting inspection readiness, scalable quality system implementation, and compliant data generation. As a senior leader in a growing startup environment, the QA/QC Director is responsible for strengthening and scaling the Quality Management System (QMS) to support clinical and commercial operations. The QA/QC Director operates under the direction of the Head of Quality and supports operational sterility controls in alignment with the site’s established sterility assurance and Contamination Control Strategy (CCS).

Requirements

Bachelor’s degree in Chemistry, Biology, Biochemistry, Engineering, or related scientific discipline
10+ years of GMP experience in biologics or sterile manufacturing
5+ years of progressive leadership experience in QA, QC, or combined QA/QC functions
Experience overseeing both QA and QC operations
Experience leading or hosting FDA inspections
Expert knowledge of FDA cGMP regulations (21 CFR Parts 210, 211, and 11)
Working knowledge of EU GMP principles (Annex 1 familiarity preferred)
Strong understanding of GMP laboratory operations and data integrity
Knowledge of ALCOA+, Part 11, and GAMP 5
Strong leadership and cross-functional collaboration skills
Strategic decision-making and risk-based judgment
Excellent written and verbal communication skills

Nice To Haves

Master’s degree in scientific or engineering discipline
CDMO or multi-client manufacturing experience
Experience building or scaling a QMS in a startup or growth environment
Experience with computerized systems validation (CSV)
Familiarity with AI/ML applications in regulated environments

Responsibilities

Lead daily QA and QC operations to ensure sustained FDA cGMP compliance
Establish, implement, and continuously improve the Quality Management System (QMS)
Ensure effective implementation of SOPs, policies, and quality procedures across departments
Develop quality metrics, dashboards, and management review processes
Support continuous inspection readiness
Drive cross-functional quality alignment within a startup growth environment
Review and approve complex or high-risk: Batch records and disposition decisions Deviations and investigations Change controls CAPAs and effectiveness checks
Ensure timely and compliant batch disposition
Provide QA oversight for manufacturing and laboratory operations
Oversee validation and qualification activities including: Equipment, utilities, and facilities Process validation Computerized systems validation (CSV)
Ensure supplier qualification processes and quality agreements are effectively implemented
Provide leadership and oversight of QC laboratory operations including: Analytical release and stability testing Microbiology testing (sterility, endotoxin, bioburden) Environmental monitoring Utilities and facilities monitoring
Ensure QC data integrity in accordance with ALCOA+ principles
Oversee investigations for OOS, OOT, and atypical results
Ensure appropriate trending and evaluation of laboratory and environmental data
Ensure computerized systems used in QA/QC activities remain qualified and validated
Apply risk-based validation approaches consistent with Part 11 and GAMP 5
Support governance of AI-enabled or automated tools used in GMP activities, ensuring: Defined intended use Appropriate human oversight Formal change control management
Maintain awareness of emerging regulatory expectations related to AI in GMP environments
Lead QA/QC preparation for FDA inspections and client audits
Serve as senior quality representative during inspections
Review and approve inspection responses and corrective action plans
Ensure sustainable inspection readiness through internal audits and risk management
Serve as senior quality interface for CDMO clients
Oversee review of CMC-related QC data and quality documentation
Participate in client audits and technical discussions
Ensure regulatory compliance while meeting client commitments