Your Role:
This position is primarily responsible for leading quality operations and compliance across the company's GxP activities, with a primary focus on GMP operations, and cGMP readiness in support of CGT and LVV manufacturing. This position supports activities related to pre-clinical, clinical and commercial manufacturing operations in accordance with US-FDA, EU, cGMP compliance and other applicable regulations.
The Associate Director, Quality Operations will report to the Senior Director, Quality Assurance and provide strategic operational leadership and oversight across assigned programs related to clinical and commercial. This role will lead day-to-day activities around clinical and commercial programs. They will work cross-functionally and with internal and external partners to ensure product quality throughout the development life cycle and provide strategic quality leadership aligned with company objectives.
Essential Duties and Responsibilities:
Quality Operations
- Oversee quality aspects of starting material, intermediates, drug substance and drug product manufacturing as well as packaging/labeling activities.
- Review and approve specifications affecting product quality and oversee the development of master batch records, process and method validation/protocol reports and other technical documents created to support all stages of the product lifecycle, from development to commercialization.
- Disposition clinical and commercial batches.
- Ensure effective CAPA management, change controls, deviations, and other GMP-related processes are followed during manufacturing and testing of products.
- Interact with manufacturing, clinical, or other functional areas that impact quality operations and provide support as needed.
- Perform risk assessments and implement appropriate quality and process controls to ensure proper oversight of production activities.
- Prompt communication to management of potential compliance issues.
- Participate in internal and external project team meetings.
Documentation and Record Control
- Perform periodic reviews and revisions of SOPs and policies, to align with regulatory updates and business needs.
- Manage other internal and external documentation related to QA operations.
Regulatory Compliance and Inspection Readiness
- Ensure Lentigen is inspection-ready, in compliance with regulatory requirements, and prepared for GMP audits or inspections from FDA or other international regulatory bodies.
- Support site preparation for regulatory inspections including personnel preparation and training.
- Participate in Quality Management Review meetings.
Operational Leadership and Continuous Improvement
- Drive continuous improvement initiatives across quality operations to enhance operational efficiency, reduce risk, and improve product quality.
- Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
- Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
- Promote a strong Quality culture within the organization. Identify compliance risks and be a part of the solution through ownership and collaboration.
- Lead, develop, and support quality assurance professionals; establish goals for the QA operations team supporting site and corporate goals.
- Lead and support quality activities on the manufacturing floor, including process validation, method validation, and tech transfers.
- Responsible for the oversight of the QA operations, raw material release, QA Engineering.
- Represent the site in Quality meetings with clients.
- Engage with regulatory bodies and clients as pertains quality operations on site.
- Review & approve batch records, specifications and QA/QC/Manufacturing SOPs to ensure compliance with quality standards
- Support the site and quality operations continuous Improvement initiatives,
- Support the client complaint process
- Ensure timely release of products to meet business and client commitments for On Time In Full release commitments.
- Ensure site and corporate quality operations metrics are implemented, met and reported at management meetings.
Requirements:
- Bachelor's Degree in life science or engineering ; A minimum of eight years' leadership experience in Quality Assurance, cGMP Compliance, or related fields in biopharmaceutical products.
- In depth knowledge of the regulatory environment (FDA, ICH, EU) for the manufacture of medicinal or investigational products, specifically aseptically filled products.
- Strong leadership skills and demonstrated success in managing a team.
- Knowledge of the Contract Manufacturing business is preferred. Experience with biologics is preferred.
- Demonstrated expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies.
- To perform this job successfully, an individual should have knowledge Excel spreadsheet software and MS Word Processing software and SAP knowledge is a plus.
Physical and Mental Demands:
- Use keyboard/computer/phone
- Ability to organize/coordinate
- Direct, control and plan solve
- Problem Solve
- Perform with frequent interruptions
- Supervise/Manage others
- Comprehend and follow instructions
- Independently make quick decisions to complex issues
- Analyze/Interpret data and information
- Make decisions using sound judgment
Work Environment:
- Regular and predictable attendance
- Work irregular hours that often include nights and weekends
The hiring range for this position is expected to fall between $167,779 - $182,573/year, reflecting the range candidates can reasonably expect to be considered for at time of offer, based on factors such as experience, internal equity, and qualifications.
The salary of the finalist(s) selected for this role will be set based on a variety of considerations, including but not limited to internal equity, experience, education, location, specialization, skills, abilities, and training. The above range represents the Company's good faith and reasonable estimate of possible compensation at the time of posting.
In addition to your salary, the Company offers a comprehensive benefits package, including health, vision, and dental insurance, as well as a 401(k) plan. All benefits are subject to eligibility requirements. Certain positions may also be eligible for additional compensation such as bonuses or commissions.
