Job Function: Quality
Job Sub Function: Quality Assurance
Job Category:People Leader
All Job Posting Locations:Athens, Georgia, 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 forQuality Assurance Senior Supervisor to be located in Athens, GA.
PurposeThe Quality Assurance Senior Supervisor is responsible for the effective supervision and operation of the site Quality Investigation Unit, under the guidance of the Site Quality Head. Implement operational procedures to ensure that the Quality Investigations Unit functions are aligned with the cGMPs and FDA guidance. Supervises and coordinates the unit's resources activities providing support, guidance, advice and continuous monitoring/feedback to the Senior Investigation Quality Leaders to ensure that final investigation reports are thorough and completed on a timely basis.
Key Responsibilities- Responsible for supervision of the Senior Investigation Quality Leaders and coordinates the overall activities related to the investigation of events in Innovative Medicine Athens, GA site.
- Ensure that all events are thoroughly investigated as per cGMPs and FDA and other Regulatory pharmaceutical industry guidance and that the final reports are accurate, adequately issued and timely completed.
- Provides leadership and direction to dotted/direct reports to satisfy both the Johnson & Johnson Innovative Medicine and the Regulatory Agency's requirements in relation to the investigation of events.
- Reviews investigation reports and monitors its progress to ensure these are completed in a timely manner, consistent with the cGMP's, Good Documentation Practices, site SOP's and policies and site operations' needs.
- Monitors the investigation unit activities to ensure resources have been adequately assigned and anticipate the need to provide or request additional assistance in accomplishing the completion of reports.
- Monitors, trends and evaluates the root causes identified in investigations in order to review the effectiveness of previously implemented actions or if additional actions are deemed necessary, such as recommending improvements to Quality Systems in light of gaps identified during the root cause analysis.
- Develops and maintains updated procedures that outline the operation of the Quality Investigation Unit to consistently and effectively meet the applicable cGMP.
- Ensures that the Investigations Unit resources are adequately and consistently trained in the procedures applicable to the position and up to date in the corresponding procedure revisions to effectively perform the duties assigned.
- Identifies and promptly notifies management of deviations or events where the quality standards of a product/material compromise marketed products and recommends action plans to remediate or to prevent such events.
- Liaise and effectively interacts with applicable functional areas to assure due date commitments that may affect material/product release are discussed or alternative actions can be implemented.
- Maintains an open communication process with other colleagues and external customers/contractors as required assisting in the evaluation of events or actions that involve the processing or testing of the products at other sites and informing management of the need to extend the investigation of the event and/or such actions.
- Provides technical assistance to the Investigation Unit resources and site functional area management and participates in the review and evaluation of GMP related issues that involve manufacturing, packaging, storage and laboratory processes, e.g., from investigations, CAPAs, APRs, changes or audits.
- Participates, leads and/or assists Cross Functional Investigations and RCPS, as required.
- Establishes an effective follow up mechanism or system to monitor that investigation activities are adequately and consistently addressed, reports issued and timely completed.
- Communicates periodically with functional areas to review and inform the result of the monitoring and trending evaluations to provide feedback on the effectiveness of the appropriate actions or demand commitments/accountability to further prevent recurrence
Qualifications - A minimum of a bachelor's degree of Science in Chemistry, Biology, Microbiology, Pharmacy, Engineering or related field is required.
- A minimum of five (5) years of experience in related areas in the pharmaceutical, biotechnology or related industry.
- Working experience in solids and/or parenteral manufacturing is highly desirable
- Expert understanding of cGMPs, Good Documentation Practices, and Regulations.
- Thorough and proven knowledge of cGMP investigation requirements and FDA Industry Guidelines for investigations
- Strong leadership skills and consistently a key contributor to the organization.
- Ability to apply statistical techniques to track and analyze process performance.
- Superior problem solving and analytical skills.
- Demonstrated ability to make sound business judgements.
- Ability to handle multiple tasks at the same time and efficiently interact and work with multiple processes, departments and across sites.
- Excellent oral and written communication skills.
- Effective in managing priorities and ability to assist colleagues directly working in assigned tasks in handling stress.
- Proficiency in time management, planning and organization capabilities
- Proficiency in handling concurrently multiple high priority initiatives maintaining focus the sense of urgency and sound quality and business judgement
- Proven and strong technical writing skills to issue reports and propose recommendations to management.
- Proficient knowledge of cGMPs and FDA regulations.
- Knowledge of computer systems GMP requirements for Part 11 compliance.
- Technical knowledge in pharmaceutical manufacturing processes, technologies and processing equipment is preferred.
- Knowledgeable and proficient in problem solving skills and statistical analysis of data as well as a high level of attention to detail.
- Proficient in the use of MS Office applications, COMET, SAP, Minitab, Document Control systems, among other applications is preferred.
- Strong technical writing skills.
- Results oriented, self-starter and ability to challenge the status quo.
- Proven ability to work under pressure and availability to work at any time needed.
- Effective in organizing work, working area, managing time and planning to achieve results.
- Self-motivated, creative and teamwork oriented.
- Proficiency in handling concurrently and effectively multiple high priority initiatives with evident sense of urgency and sound Quality minded approach.
- Decision Making: makes timely, technically/regulatory sound and science-based decisions which are communicated to management as a result of work performed.
- Proficiency in evaluation of analytical results, data, experiments, professional literature and technical manuals is preferred.
Required Skills: Preferred Skills:Business Savvy, Compliance Management, Corrective and Preventive Action (CAPA), Cross-Functional Collaboration, Developing Others, Fact-Based Decision Making, Give Feedback, Human-Centered Design, Inclusive Leadership, ISO 9001, Leadership, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Risk Assessments, Standard Operating Procedure (SOP), Team Management
