Director Parenteral, Quality Assurance - Johnson and Johnson

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.

Education:

A minimum of a Bachelor's or equivalent University degree with a focus in Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering preferred. Master's in science or Engineering is highly preferred.
Experience and Skills:

Required:

• Minimum of 12years of experience in the pharmaceutical industry, ten of them in a parenteral operation.
• Minimum eight (8) years of experience in a managerial role. Five (5) years of experience in Quality leadership role is required.
• Knowledge in equipment and process validation, environmental conditions and monitoring, aseptic processing, technology transfer, release, regulatory, lyophilization and troubleshooting of aseptic and combination products.
• Vast knowledge of lyophilization and sterilization processes preferred.
• Shown experience in implementing quality systems. Develops and implements strategy for cGMP's compliance for the site.
• Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies and management of regulatory inspections.
• The position requires skills in problem-solving and analysis, including interpreting complex documents and preparing presentations. Candidates should be able to work both independently and in teams, follow technical instructions, meet deadlines, make precise decisions quickly, and possess strong interpersonal skills.

Other:

• Be fluent in Spanish and English and must have excellent ability to write in English and Spanish.
• Must exercise judgement on the resolution of production problems to meet company standards for quality, cost and critical success factors.
• Availability for traveling, working irregular shifts, frequently requires working extended hours, and might be required to work on holidays and weekends.
• Be proficient in the use of MS Office applications: Word, Excel, Power Point, and Internet.
• Knowledge in process excellence and project management tools.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .]