Quality Operations Lead

Johnson & Johnson Innovative Medicine•Irving, TX

About The Position

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. Johnson and Johnson is recruiting for a Quality Operations Lead located in Irving, TX. Leads Quality Operations group to ensure that performance and quality of products conform to established company and regulatory standards. Plans, coordinates, and directs quality assurance programs designed to ensure continuous production of products consistent with established standards. Establishes and maintains quality assurance programs, procedures, and controls.

Requirements

Minimum 8 years related experience in quality, operations, or regulatory functions.
University/bachelor’s degree or equivalent is required.
A degree in Engineering, Science or other technical discipline is preferred.
Experience in the Medical Device industry or regulated medical field is required.
Prior management experience is required.
Understanding of Software/system/database validation
Based on education and/or experience, be able to provide appropriate technical input and review of product realization activities including but not limited to design control, validation, and production process controls, product release, and material controls.
Ability to perform duties in accordance with policies and procedures.
Advanced computer skills and use of software applications (MS Office, MS Project Management, PowerPoint, Word, Excel, Outlook etc.)
Proficient in project management, creating credibility within team members and expanding capabilities of the group.
Strong Organizational, interpersonal, oral and written communication, presentation skills.
Ability to communicate compliance requirements to business partners and to respond to regulatory agencies during inspections or similar requests.
Ability to prioritize multiple commitments and support technical problem-solving duties.
Ability to shift priorities according to changes in company/department needs and open to different ideas/approaches.

Nice To Haves

Six Sigma Green Belt or Black Belt is recommended.
ASQ membership, CQE or CQA certification is preferred.

Responsibilities

Responsible for oversighting quality engineering group in collaboration with other functional areas to ensure effective & efficient manufacturing operation.
Ensures that performance and quality of products conform to established company and regulatory standards.
Oversight the nonconformance process in collaboration with operations including verification of bounding, disposition of non-conforming material, verification of corrective action or effectiveness check where applicable
Advises staff to help meet established operational schedules translated from goals & objective or resolve technical or operational problems.
Formulates and maintains quality assurance objectives and coordinates objectives in cooperation with other manufacturing managers to maximize product reliability and minimize defects/costs.
Determines improvement direction or product line modifications to drive proactive quality which include data evaluation/monitoring against risks, drive cost/quality improvement project, ensure effective implementation/error remediation in production related system/databases.
Overall driver of CAPA process which includes but not limited to: identification process/system gaps, reviewing investigation report findings, make recommendation for corrective action, ensure effective implementation of CAPA, and verification of effectiveness.
Provides Data Analysis, trending and potential gaps with proper risk analysis for Management Review including monitoring key quality performance measures and corrective action results.
Assess use of internal quality data as a predictor to reduce/eliminate product complaints.
Submits and administers budget schedules and performance standards.
Lead efforts in the use of process excellence tools to enhance analytical thinking and problem-solving techniques within staff.
Support and promote cost saving opportunities that work toward global objectives in the organization and improve quality attributes.
Manages the qualification and validation for all products and processes and quality control support activities.
Provides quality support to the supplier quality assurance as requested or needed.
Manage all investigations related to quality issues escalated to Risk Management Board to include completion of escalation forms, failure investigations, and required presentations.
Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, change control, and quality systems.
Organizes, plans, leads and manages quality related projects in alignment with company goals.
Lead on-going continuing efforts and projects to improve the site manufacturing quality systems and processes.
Facilitates the development and training of immediate staff.
Develops the strategy, with tactical and operational plans for the quality function and ensures that tactical objectives are met in support of strategic targets.
Leads quality engineering activities for process projects and product transfer into production.
Oversees and leads quality investigations (Non-conformance and CAPA) and/or internal audits to assess conformance to specifications, company procedures, and overall compliance to regulations.
Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
Oversees and ensures proper execution and compliance in complaint handling investigations performed by the site.
Oversese the quality review resulting from statistical and data analyses for projects involving the design, development or validation of new or existing products and processes.
Demonstrate independent understanding and application of core GMP fundamentals, including but not limited to: Data Integrity (DI), Good Manufacturing Practices (GMPs), and Good Documentation Practices (GDPs).
Responsible for communicating business related issues or opportunities to next management level
Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed