Job Information
J&J Family of Companies Asst manager, Quality Operations and Performance in Bihar, India
Asst manager, Quality Operations and Performance - 2406212778W
Description
Job Title: Asst. Manager - Quality Operations and Performance
Job purpose of Asst Manager - Quality Operations & Performance under the direction of the Site Quality Head, has the responsibility for driving continuous Quality Excellence, maintaining supply chain compliance, providing franchise support, and communicating internal and external customer facing needs to Site Quality Leaders. This includes support in the delivery of critical initiatives for Medical Device and Supply Chain Quality. In thisrole, he/she will coordinate and drive on-time and flawless project execution, Business Plan & Performance oversight within the site and will work closely with the franchise Quality team to drive end to end Supply Chain Quality execution, alignment, and optimization across the network, including development and execution of Operational Excellence strategy within their sites.
Responsibilities:
Ensure compliance with applicable regulations and policies, standards, including FDA, safety, and environment.
Aid in development of site Quality strategy and impactful G&Os with inputs from the Supply Chain Quality organization, franchise, region, and other partners.
Responsible and champion for successful development, deployment and implementation of strategies and associated policies, procedures, programs, and initiatives that deliver quality, compliance, cost and/or operating benefit to the supply chain.
Champion an E2E approach and collaborate with global franchise Supply Chain Quality organization and other functions to provide insights, benchmark, and drive quality improvement actions.
Support site quality strategic plan, annual goals, BP, LRFP, JU, NU and all business and financial cycle related activities within the site.
Provide site Quality program/project portfolio updates such as JJPS, TQI, capacitymodel and be accountable for progress of site quality capital investments, CIPs, and other pivotal initiatives.
Demonstrate strong leadership and ability to engage and guide the site members of Quality Organization on quality improvement culture and new thinking, attitudes, and behaviors.
Act as a change agent to promote use of tools and approaches to redesign current processes for the vision and strategy of the future including shaping the Quality organization structure, providing agile processes, and building capable site teams.
Partner with individuals and teams to develop and implement innovative solutionsandcontinuousimprovementswithprovenandmeasurablebusinessresults.
Exercise the highest level of integrity in the tasks performed.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices.
Responsible for ensuring personal and Company compliance with all Federal,State, local and Company regulations, policies, and procedures.
Support Quality Operations / Quality control activities as required by the business.
Make recommendations to management regarding ways to improve manufacturing processes, increase product quality and delivery while reducing production cost.
Responsible for revision/creation of documents in applicable document management system
Maintains close interaction and network with peers at Ethicon Worldwide Plants to address quality related issues.
Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notifies anyviolation or deviation to the immediate supervisor or appropriate authority.
Complies with all training requirements to perform duties of the job.
Qualifications
Qualifications:
Post Graduate / Graduate in Pharmaceutical Sciences / Postgraduate in Science with minimum 8 years relevant experience in Quality Assurance / Quality Control function and experience in a highly regulated environment is required including a broad and deep working knowledge of the operating functions of quality and compliance, supply chain, material supply and material handling and control, product manufacturing and product packaging.
Green belt certification in lean six sigma with demonstrated experience in quality projects is desirable.
An understanding and application of cGMP and internal/external Health
Authority compliance expectations is required.
Excellent communication, collaboration, and influencing skills across multiple functions and levels within the organization is required.
Prior experience with project management, Lean, Six Sigma, Operational Excellence, change management training and/or certification is desirable.
Working knowledge of Softwares used in quality function for document control, change control, ERP etc.
SKILLS,ABILITIES,CERTIFICATIONS/LICENSESand AFFILIATIONS
- Technical & Behavioral Skills
Demonstrate knowledge and application of MDR 2017, Drugs & Cosmetics Act,ISO-9001, ISO- 13485 and other relevant international standards for medical devices.
Knowledge of applicable laws and regulations, manufacturing environment.
Thorough understanding of process criteria and regulations and businessimpact of decisions and actions
Primary Location Asia Pacific-India-Bihar-Aurangabad
Organization Johnson & Johnson Private Limited (8080)
Job Function Quality Systems
Req ID: 2406212778W