Johnson & Johnson Careers
Senior Director, Plant Quality Assurance
Requisition ID: 3512181003
Ethicon Surgical Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Director, Plant Quality Assurance. This role will be based in Cornelia, GA.
The Ethicon Surgical Care business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon Surgical Care business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today. Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
You, the Senior Director, Plant Quality Assurance will:
- Lead the quality activities across three medical device manufacturing sites ensuring the appropriate staffing is available at all times and skills and competencies are consistent with present and future needs, verifying that Quality Systems are in place to maintain the required compliance level across the manufacturing site, and driving Quality System (QS) execution while reducing risk of non-conforming product.
- Ensures sites assess QS effectively through internal audit and Management Review, and implements corrective/ preventive, improvement actions as appropriate. Ensures sites address customer feedback and complaints in appropriate and timely manner. Ensures that sites’ implementation of Quality Systems and goals are integrated in a cost effective and productive manner.
- Establishes and maintains QS procedures and controls ensuring that performance and quality of the product conforms to established company and regulatory standards.
- Establishes and monitors metrics for the measurement of Quality indicators and Quality costs to ensure effectiveness and value to the business.
- Developing & implementing annual budgets & organization plans.
- Ensures sites fulfill all Quality Agreement requirements.
- Leads the plant staff in the understanding, development and deployment of key strategies, continuous improvement opportunities and customer focus initiatives.
- Leads the identification and analysis of risks, and leads the implementation of preventive and corrective actions to address risks.
- Develops and disseminates strategy for talent attraction, development and retention to enhance the Quality Operation’s talent pipeline. Ensures manufacturing sites have appropriate resources with the right competencies to execute the Quality System.
- Provides active link and partnership between the sister sites, franchise partners, regions and enterprise functions. Partners with management to develop and support initiatives and responses to internal issues. Fosters resource leverage across sites and regions, ensures alignment or harmonization where required and/or appropriate.
- Executes responses to field actions and coordinates global response in partnership with the franchise Quality leadership and enterprise functions.
- Oversee release systems of all products manufactured at sites.
- Oversee & direct participation in quality systems improvement, cost reduction, cycle time reduction, & profit improvement programs.
- Collaborate with all business representatives to further corporate goals, values & objectives
- Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).
Driving a turnaround to bring site quality performance up to standard
- Develop and implement a holistic multi-year strategy across culture, people, processes and systems.
- CAPA performance, Internal audit observation performance, resource management.
- Balancing challenges in the short/mid-term with a focus on the long-term potential.
- Challenge the status quo to implement new ways of doing things that are proven practices outside the organization.
- Strong performance with positive impact when interacting with regulatory bodies.
Leading the implementation of a proactive quality culture site-wide
- Build credibility to influence trade-offs with Supply Chain that provide end-to-end value and ensure the protection of patient safety.
- Instill quality mind-set site-wide through capability building within and outside of Quality function.
- Making tough talent decisions.
- Demonstrating fortitude to stand in front of Supply Chain management regarding possible Quality calls.
- Taking a stand for tough calls; being the lone voice in the room.
- Working with difficult or strong personalities.
- Working through multiple set-backs and unforeseen challenges without losing ‘winning spirit’.
- Consistent ‘beacon of hope’ for Quality organization.
INSPIRE AND MOTIVATE
- Ability to paint a vision of the future that is relatable to all levels of the Quality organization and site-wide.
- Inspire intellectual curiosity in the Quality organization to collaborate outside of Cornelia and bring best practices into the organization from other segments.
- BS degree in Business, Life Science, Physical Science, Engineering or other related field required, Master’s Degree preferred.
- Minimum of 10 years of combined experience in Regulatory, Compliance, Quality Management and/or Supply Chain in a regulated (FDA) environment.
- Minimum of 5 years people leadership experience is required.
- Experience driving high performing cross-functional and indirect teams that deliver results is required.
- Experience leading a turnaround strongly preferred. For example, driving remediation programs, transforming Quality Systems and Culture.
- Experience in Medical Device segment is required; experience outside of the Medical Devices segment an asset.
- Strong experience and proven record motivating leading and developing staff, in a highly changing environment is required.
- Six Sigma, Quality Engineer, Quality Auditor and/or Quality Manager Certifications are preferred.
- The Senior Director is required to be based in Cornelia, GA, and will be required to travel up to 20% of the time.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Ethicon Inc. (6045)