Quality Systems Lead

Quality Systems Lead

Under the management of the Site Quality Lead this position will have the objective of maintaining high quality standards for the product manufacturing process and compliance with all applicable regulatory requirements.

Manages the day-to-day operations of the Quality Systems and training staff. Oversees the development and implementation of processes, procedures, audits and corrective actions. Oversees the development and implements training programs that support company objectives and meet regulations Oversees the QS archiving process. Ensures effective communication and training are deployed throughout the business. At this level the role has increased responsibility including, but not limited to, additional skills, multiple lines/products, diverse teams, etc.

Duties & responsibilities

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Assigns tasks and projects to staff. Tracks progress and reallocates resources as necessary.
• Manages the implementation and administration of quality management systems in accordance with applicable standards.
• Compiles data and prepares reports and metrics on system effectiveness for management.
• Site Management review: Leads the Site Management Review process to allow meaningful review.
• CAPA: Manages the CAPA process and the Data Review Board (DRB) meetings.
• Non-Conformance (NC): Manages the NC process.
• Record Management: Manage Record management process.
• Change Control and Document Control: Manages Change Control and Document Control processes.
• Quality System Policies and Procedures: Manages the control of Quality System Policies and Procedures.
• Quality Agreements: Manages the control of Quality Agreements.
• Consults with management, employees, and departments to identify training needs, address them and achieve the end result of effective training solutions.
• Creates new training materials as required in collaboration with subject matter experts.
• Provides support in the internal and external audit programs.
• Develops and maintains a training program to support the company needs and meet applicable local, federal and state laws/regulations.
• Experience as subject matter trainer to conduct training sessions i.e. quality system related topics and to certify employees as trainers across the company.
• Knowledge in Learning Management System (LMS) and its use to deploy training programs and requirements across the company.
• Mentors, coaches, trains and develops direct reports. Evaluates performance and provides opportunities for growth.
• Responsible for communicating business related issues or opportunities to next management level
• 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 applicable regulations, policies, and procedures
• Leads projects of moderate to high complexity
• Performs other duties assigned as needed

University / bachelor’s Degree or Equivalent

Minimum of 6 years in similar environment with medical device or pharmaceutical company, with relevant QS experience. A minimum of 2 years of people management experience is required

Background in Statistics, Process Excellence is preferred.

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

• Excellent communication skills, able to quickly build credibility within the company and the executive management.
• Proven track record of demonstrating collaboration across the organization and at all levels
• Balanced technical understanding of products and processes combined with superior business and compliance acumen
• Probability and statistical inference, and fundamentals of other mathematical disciplines. Able to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity and sampling theory.
• Ability to define and resolve problems. Collect data and analyze data, establish facts and draw scientifically valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results.
• Capacity to put the customer central to all thinking
• Ability to recognize, build support for change and engage in constructive conflict.
• High tolerance for ambiguity in a complex environment
• Ability to make the complex clear and easily understood by others
• Able to generate enthusiasm for best-in-class performance through the clear personal passion to be the best in these areas
• Ability to build partnerships both internally and externally
• Strong leadership and coaching skills
• Demonstrated project management abilities
• Proficient in Microsoft Office —Word, Excel, and PowerPoint
• A thorough understanding of GMP (Good Manufacturing Practices)/ISO (International Organization for Standardization) regulations is preferred.
• Proven experience designing and presenting successful training programs.

Preferred Skills:

Analytical Reasoning, Analytics Dashboards, Collaborating, Compliance Management, Data Gathering and Analysis, Data Quality, Incident Management, Performance Measurement, Process Improvements, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, Risk Management, System Integration, Systems Analysis, Tactical Planning, Technical Credibility

Hybrid Work