Senior Manager, Preclinical Operations (Robotics & Digital Surgery) - Ethicon, Inc.
Ethicon Robotics & Digital , part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars, hemostats, and robotics & digital surgery plus our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .
This role will be located ON-SITE in either Redwood City, CA and/or Santa Clara, CA and will travel between locations frequently. Candidates may reside within a commutable distance of either city. Relocation assistance is available to qualified candidates.
The Senior Manager of Preclinical Operations in Preclinical affairs will serve as test facility management and leader of preclinical operations within the animal facilities of Johnson & Johnson MedTech locations in Santa Clara, CA and Redwood City, CA. These facilities support the execution of preclinical studies required to competitively position robotic and digital solutions for regulatory approval and clinical acceptance. The position is responsible for the GLP program across both locations and will represent the facilities in all audit activities. The role works closely with the Director of Preclinical Affairs to understand project requirements and testing timelines to efficiently manage resources for preclinical study execution within the vivarium. The position is also responsible for managing the quality system, operational SOPs, and leading external vendor management for Preclinical Affairs.
POSITION DUTIES & RESPONSIBILITIES:
Under limited supervision and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position will:
· Serve as Test Facilities Management for all preclinical studies within the animal facilities at the Johnson & Johnson MedTech locations in Santa Clara, CA and Redwood City, CA.
· Oversee the management of the Preclinical Research quality system, including the implementation and oversight of procedures and processes for non-GLP and GLP preclinical studies within the animal facilities.
· Subject Matter Expert and mentor on 21 CFR part 58 for the Preclinical Research staff in the conduct of Good Laboratory Practices for Nonclinical Laboratory Studies.
· Responsible for the development of Quality Metrics to drive quality improvement initiatives.
· Develop and lead periodic preclinical quality review meetings designed to track key performance indicators of quality compliance in Preclinical Affairs to ensure appropriate management oversight and escalation. Utilize KPI to drive continuous quality improvement.
· Ensure excellence in quality and execution of internal preclinical animal studies that meet regulatory and corporate requirements and deliver on project goals across MD.
· Manage and prioritize Preclinical Operations budget to meet key business objectives.
· Establish, track, and maintain a risk assessment process for phase audits.
· Responsible for the GLP program across preclinical facilities and identified as key contact representative for all internal and external audits of preclinical programs/facilities/activities.
· Oversee the management of Preclinical Affairs Archiving.
· Direct staff in the development of Preclinical Training curriculum.
· Direct staff in the development and implementing Quality Document Management.
· Direct process improvements (develop/implement continuous quality improvement).
· Responsible for oversight and ensure resourcing of lab and facility utilization.
· Develop and implement a vendor management strategy to assess, monitor, and track performance/quality of external vendors used in the execution of animal studies.
· Ensure vendors are audited and compliant to company standards for GLP study activities and animal welfare.
· Responsible for communicating business related issues or opportunities to next management level.
· Partner with preclinical peers to identify and prioritize critical equipment and model capabilities needed in the animal test facilities.
· 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.
· Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures.
· Performs other duties assigned as needed.
The base pay range for this position is $155,000 to $255,000 based on experience . The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
EXPERIENCE AND EDUCATION
· Minimum of a Bachelor’s Degree is required .
· Minimum of 5-7+ years of experience in a preclinical operational leadership role in a pharmaceutical, medical device, or contract lab setting is required .
· Experience in the Medical Device industry is strongly preferred .
· 1+ years’ experience in managing FTE and contracted staff is required .
· Demonstrated knowledge of preclinical practices and procedures is required.
· Advanced knowledge of 21 CFR part 58 and its application in a GLP Program is required .
· Experience in managing complex projects driving quality improvement.
· Knowledge of animal welfare and care regulations is preferred .
· Ability to work cross-functionally with both internal & external stakeholders.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES, AFFILIATIONS
· Demonstrated experience in GLP program implementation / management / execution.
· Demonstrated experience in Quality System Management.
· In depth understanding of GLP Test Article Management
· In depth understanding of GLP Archive Management.
· Demonstrated experience in Project Management execution.
LOCATION & TRAVEL REQUIREMENTS
· Primary location of the position can be at either Johnson & Johnson MedTech animal facilities (Santa Clara, CA and Redwood City, CA). Regular travel back and forth between the two locations is required on a recurring basis.
· Domestic travel may be occasionally required for training purposes (<10%).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.