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: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.
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
