Associate Director, Quality Assurance (Operations) PC 483

Miltenyi Biomedicine•Gaithersburg, MD

5d•$167,779 - $182,573

About The Position

The Associate Director, Quality Assurance (Operations) leads quality operations and compliance across the company’s GxP activities, primarily focusing on GMP operations and cGMP readiness for cell and gene therapy (CGT) and lentiviral vector (LVV) manufacturing. The role supports pre-clinical, clinical, and commercial manufacturing in accordance with US FDA, EU cGMP, and other applicable regulations. Reporting to the Senior Director, Quality Assurance, the position provides strategic operational leadership and oversight for assigned clinical and commercial programs, leads day-to-day activities, and works with internal and external partners to ensure product quality throughout the development lifecycle. The role oversees quality aspects of manufacturing, packaging, and labeling; batch disposition; GMP processes; documentation and record control; inspection readiness; and continuous improvement. It also leads and develops QA professionals, supports manufacturing-floor quality activities, oversees QA operations, raw material release, and QA Engineering, and represents the site in quality interactions with clients and regulatory bodies.

Requirements

Bachelor’s degree in life science or engineering.
At least eight years of leadership experience in Quality Assurance, cGMP Compliance, or related fields in biopharmaceutical products.
In-depth knowledge of FDA, ICH, and EU regulatory requirements for manufacturing medicinal or investigational products, specifically aseptically filled products.
Strong leadership skills and demonstrated success managing a team.
Expertise in inspection readiness, regulatory inspections, and inspection response management, including FDA Form 483 responses, commitments, and remediation strategies.
Knowledge of Excel and Microsoft Word.

Nice To Haves

Knowledge of the contract manufacturing business.
Experience with biologics.
Knowledge of SAP.

Responsibilities

Oversee quality aspects of starting materials, intermediates, drug substance, drug product, and packaging and labeling activities.
Review and approve product-quality specifications and oversee development of master batch records, validation protocols and reports, and other technical lifecycle documentation.
Disposition clinical and commercial batches.
Ensure effective management of CAPAs, change controls, deviations, and other GMP processes during product manufacturing and testing.
Collaborate with manufacturing, clinical, and other functional areas that affect quality operations, providing support as needed.
Conduct risk assessments and implement appropriate quality and process controls for production oversight.
Promptly communicate potential compliance issues to management.
Participate in internal and external project team meetings.
Periodically review and revise SOPs and policies to reflect regulatory updates and business needs, and manage other QA operations documentation.
Maintain inspection readiness and regulatory compliance, and prepare for GMP audits or inspections by the FDA and other international regulatory bodies.
Support regulatory inspection preparation, including personnel preparation and training.
Participate in Quality Management Review meetings.
Lead continuous improvement initiatives to improve operational efficiency, reduce risk, and enhance product quality.
Provide strategic direction and hands-on leadership for operations teams in alignment with business goals and regulatory requirements.
Develop and implement operational performance metrics, report results, identify improvement areas, and ensure corrective actions are implemented.
Promote a strong quality culture and collaborate to identify and address compliance risks.
Lead, develop, and support QA professionals, and establish goals for the QA operations team aligned with site and corporate goals.
Lead and support manufacturing-floor quality activities, including process validation, method validation, and technology transfers.
Oversee QA operations, raw material release, and QA Engineering.
Represent the site in quality meetings with clients and engage with regulatory bodies and clients on site quality operations.
Review and approve batch records, specifications, and QA, QC, and Manufacturing SOPs for compliance with quality standards.
Support site and quality operations continuous improvement initiatives and the client complaint process.
Ensure timely product release to meet business and client on-time-in-full commitments.
Ensure site and corporate quality operations metrics are implemented, achieved, and reported at management meetings.