Quality Assurance Manager Parenteral

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

People Leader

All Job Posting Locations:

Gurabo, Puerto Rico, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for QA Manager, Parenteral to be located at Gurabo, PR.

The Quality Assurance (QA) Manager, Parenteral is accountable for providing technical knowledge, direction, and support of assigned products including areas such as Chemistry, Microbiology laboratories and the Quality Assurance for the final disposition of the products. Reviews, identifies and implement changes to technology, people and/or processes to assure compliance with regulatory and organization policies and to maximize process efficiency and conformance. The Manager, is responsible to lead, manage and provide direction to the Quality Assurance activities related to biotherapeutics commercial products.

Provides technical and compliance knowledge to ensure that the manufacture and management of the product have the appropriate systems and testing processes in place in compliance with cGMP and GLP, corporate standards, federal and international regulations, and industry practice. Supports the review and approval of procedures and specifications, significant investigations, product reviews, equipment/facility modification, and critical validation documents to ensure regulatory compliance.

In the absence of the QA Director, leads discussions on solutions to problems with manufacturing processes, in-process product, final product release and product complaints support to ensure that all problems are resolved in a timely manner.

Key Responsibilities

• Supports budget management, organizational structure and business requirements to accommodate business needs and assure metrics.

• Works closely with Research and Development Organization (or affiliate, etc.) and the Gurabo site team members to assure issues are addressed in a timely manner and that appropriate activities are scheduled and completed.

• Effectively supports launches of products and technologies.

• Partners with the Compliance Team to perform internal audits and support sites during FDA/International PAIs.

• Must be knowledgeable of Quality Risk Management concepts and should lead teams in the execution of Quality Risk Assessment exercises.

• Partners with other JSC functions (Sterility Assurance) to ensure consistent application of parenteral manufacturing practices.

• Participates in industry forums to assess/gather information on current trends.

• Responsible for the supervision, coaching and development of assigned personnel.

• Assures that all assigned personnel have the education, training and experience, or a combination of these, in order to carry out all job duties and responsibilities.

• Prepares the Performance Developmental Plan (PDP) of supervised personnel.

• Performs corrective/disciplinary actions, when necessary, when company policies and procedures are not followed.

• Actively participates in the planning and execution

Qualifications:

•  A minimum of 6 years of related work experience in pharmaceutical industry and parenteral products is required.

• A minimum of a bachelor’s degree in science or related field is required.

• Knowledge of contamination controls and combinations products is preferred.

• Knowledge of cGMP’s, record control specifications, and experience in regulatory inspections. Requires overall experience in the Quality Assurance Unit.

• Knowledge in equipment and process validation, environmental, Microbiological challenge environment, release, regulatory, lyophilization and troubleshooting of aseptic products.

• Knowledge of lyophilization and sterilization processes.

• Develops and implements strategy for GMP’s compliance for the site.

• Proven experience in implementing quality systems.

• Experience in regulated environmental (FDA, MHRA) and other worldwide regulatory agencies. Experience in the management of regulatory inspections.

• Strong communication skills, ability to write and speak in English and Spanish is required.

• This position may require up to a10% of domestic and/or international travel

• Leadership skills is preferred.

• Proficiency with MS Office tools is preferred.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

 

 

Required Skills:

 

 

Preferred Skills:

Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Good Manufacturing Practices (GMP), Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Risk Assessments, Standard Operating Procedure (SOP), Tactical Thinking, Team Management