Director Parenteral, Quality Assurance

Johnson & Johnson is currently recruiting a Director Parenteral, Quality Assurance! To support a parenteral manufacturing facility that also supports the manufacture of a combination product under the Janssen-Cilag Manufacturing LLC entity. This position will be located in Gurabo, Puerto Rico.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Position Summary:

The QA Director will be accountable for providing technical knowledge, direction, and support of assigned products including areas, such as Chemistry, Technology Transfer, Microbiology Laboratories and the Quality Assurance for the manufacture and final disposition of products. Responsible for ensuring the conformance of manufacturing, packaging and product transfers activities with the current Good Manufacturing Practices, Janssen policies, standards and internal procedures.

The QA Director will provide technical and compliance knowledge to ensure that the manufacture and management of the products have the appropriate systems and testing processes in place in compliance with cGMP and GLP, corporate standards, federal and international regulations, and industry practices. Supports the review and approval of procedures and specifications, significant investigations, product reviews, equipment/facility modification, and validation documents to ensure regulatory compliance. Leads discussions on solutions to problems with manufacturing processes, in-process product, final product release and product complaints to ensure timely resolution. Serves as the back up to the Site Quality Head of the Gurabo site.

Key Responsibilities:

• Acts as the Parenteral site Management Representative in line with Johnson & Johnson Quality Policies and Health Authorities regulations.


• Monitors and reviews the quality management system for compliance, effectiveness, and improvement opportunities.


• Promotes awareness of regulatory requirements and monitors key quality performance measures.


• Manages the CAPA system, reports to management, and initiates corrective/preventive actions.


• Develops strategies for cGMP compliance, budget management, and operational structure for business needs.


• Participates in product transfer teams to ensure compliance with cGMP and internal procedures.


• Collaborates with Product and Analytical Development teams to address issues and schedule activities.


• Supports product and technology launches and participates in stage gate reviews.


• Partners with Compliance Team for internal audits and handles customer complaints in compliance with cGMP.


• Leads Quality Risk Assessment exercises and ensures consistent manufacturing practices across sites.


• Supervises, coaches, and develops assigned personnel; ensures training and performance assessments.


• Recommends modifications to policies and participates in achieving strategic goals.


• Observes and makes sure compliance with all company policies and regulations.


• Supports Process Excellence Projects, ISO 14001 improvement, and Environmental and Safety initiatives.


• Serves as the Site QA Qualified Person per China Drugs GMP Regulations.