Manager, Quality Assurance (QA) Preclinical Auditor - J&J Family of Companies
Santa Clara, CA
About the Job
Manager, Quality Assurance (QA) Preclinical Auditor - 2406217771W
Description
Johnson & Johnson MedTech is recruiting a Manager, Quality Assurance (QA) Preclinical Auditor to be located in Santa Clara, California or Cincinnati, Ohio .
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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology. We harness our deep expertise in surgery, orthopedics, vision, and interventional solutions to design healthcare solutions that are smarter, less invasive, and more personalized. The MedTech Surgery organization was recently established to combine Ethicon’s market-leading surgical portfolio with the Robotics & Digital Solutions portfolio. The MedTech Surgical organization is comprised of: Wound Closure & Healing and Biosurgery, Endo Mechanical and Energy, OTTAVA (Surgical Robotics), MONARCH (Flexible Robotics), and MedTech Digital.
Our Manager, QA Preclinical auditor is responsible for applying the Good Laboratory Practice regulations to help the company achieve two major objectives in support of the J&J Credo: Meet and exceed the expectations of our customers; and achieve and maintain compliance with regulatory expectations. To support business objectives, a successful Manager, QA Preclinical Auditor will have orientation to the big picture and attention to detail. Are you interested in joining a team that is developing the next generation of innovative devices that serve our surgeons and patients? Apply today!
Key Responsibilities:
+ The Manager of Preclinical Quality Assurance will independently lead the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory GxP requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a support or lead role.
+ Support other auditors in planning, conducting and reporting of audits.
+ Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
+ Support the CAPA process following the audit as needed.
+ Encourage and support others to properly manage and document the risk-based approach in audit planning and conduct.
+ Participate in regulatory inspections in a leadership role (e.g. host, backroom lead).
+ Identify training needs, support development and provide training. Independently advise and coach other auditors.
+ Supervise junior auditors / contractors and peer review audit reports.
+ Lead initiatives and actively participate in key projects across the organization or company. Effectively influence key business partners to drive projects to completion.
+ Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.
+ Independently provide consultation and advice to business partners on quality and compliance processes / procedures.
+ Interpret and apply regulations / policies to unique and / or complex issues.
Qualifications
Education:
+ A minimum of a University/Bachelors or equivalent degree is required, preferably in a Scientific or Technical field.
Experience & Skills
Required:
+ A minimum of eight to ten (8-10) years of professional work experience in Quality Assurance, with a thorough understanding and experience with the application of Good Laboratory Practices (GLP).
+ Experience working in the Medical Device or Pharmaceutical industry.
+ Experience leading a cross-functional team.
+ Ability to identify and simplify complex issues, as well as apply a proactive, organized, and systemic approach to making decisions and resolving issues.
+ Ability to work in a team and demonstrate strong interpersonal, organizational, and oral/written communication skills.
+ Ability to work independently or autonomously with minimal guidance.
+ Experience in a R&D/Pre-Clinical QA, analytical, R&D laboratory and/or animal facility environment.
Preferred:
+ Experience in medical devices or other highly regulated industry; military veteran leadership experience is an asset.
+ Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.)
+ Certification (e.g. Society of Quality Assurance, Registered Quality Professional - GLP - RQAP-GLP).
Other:
+ Up to 30% travel, domestic and international, required.
+ The anticipated base pay range for this position is $99,000 to $170,200.
+ In the California Bay Area - The anticipated base pay range for this position is $113,000 to $195,730.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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.
+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
+ Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
+ Employees are eligible for the following time off benefits:
+ Vacation – up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
+ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
+ Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-Ohio-Cincinnati
Other Locations NA-US-California-Santa Clara
Organization Auris Health, Inc. (6267)
Relocation Eligible: No
Travel Yes, 25 % of the Time
Job Function Quality Assurance
Req ID: 2406217771W
Description
Johnson & Johnson MedTech is recruiting a Manager, Quality Assurance (QA) Preclinical Auditor to be located in Santa Clara, California or Cincinnati, Ohio .
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 https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential. At Johnson & Johnson, we all belong.
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology. We harness our deep expertise in surgery, orthopedics, vision, and interventional solutions to design healthcare solutions that are smarter, less invasive, and more personalized. The MedTech Surgery organization was recently established to combine Ethicon’s market-leading surgical portfolio with the Robotics & Digital Solutions portfolio. The MedTech Surgical organization is comprised of: Wound Closure & Healing and Biosurgery, Endo Mechanical and Energy, OTTAVA (Surgical Robotics), MONARCH (Flexible Robotics), and MedTech Digital.
Our Manager, QA Preclinical auditor is responsible for applying the Good Laboratory Practice regulations to help the company achieve two major objectives in support of the J&J Credo: Meet and exceed the expectations of our customers; and achieve and maintain compliance with regulatory expectations. To support business objectives, a successful Manager, QA Preclinical Auditor will have orientation to the big picture and attention to detail. Are you interested in joining a team that is developing the next generation of innovative devices that serve our surgeons and patients? Apply today!
Key Responsibilities:
+ The Manager of Preclinical Quality Assurance will independently lead the planning, conduct, reporting of R&D Quality QA routine and non-routine audits/assessments/inspections of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory GxP requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope. Manages complex or business critical audits/issues in a support or lead role.
+ Support other auditors in planning, conducting and reporting of audits.
+ Ensure the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
+ Support the CAPA process following the audit as needed.
+ Encourage and support others to properly manage and document the risk-based approach in audit planning and conduct.
+ Participate in regulatory inspections in a leadership role (e.g. host, backroom lead).
+ Identify training needs, support development and provide training. Independently advise and coach other auditors.
+ Supervise junior auditors / contractors and peer review audit reports.
+ Lead initiatives and actively participate in key projects across the organization or company. Effectively influence key business partners to drive projects to completion.
+ Actively shares business area and regulatory knowledge/expertise. May act as a primary contact for internal and/or external stakeholders.
+ Independently provide consultation and advice to business partners on quality and compliance processes / procedures.
+ Interpret and apply regulations / policies to unique and / or complex issues.
Qualifications
Education:
+ A minimum of a University/Bachelors or equivalent degree is required, preferably in a Scientific or Technical field.
Experience & Skills
Required:
+ A minimum of eight to ten (8-10) years of professional work experience in Quality Assurance, with a thorough understanding and experience with the application of Good Laboratory Practices (GLP).
+ Experience working in the Medical Device or Pharmaceutical industry.
+ Experience leading a cross-functional team.
+ Ability to identify and simplify complex issues, as well as apply a proactive, organized, and systemic approach to making decisions and resolving issues.
+ Ability to work in a team and demonstrate strong interpersonal, organizational, and oral/written communication skills.
+ Ability to work independently or autonomously with minimal guidance.
+ Experience in a R&D/Pre-Clinical QA, analytical, R&D laboratory and/or animal facility environment.
Preferred:
+ Experience in medical devices or other highly regulated industry; military veteran leadership experience is an asset.
+ Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Operations, QA, laboratories, etc.)
+ Certification (e.g. Society of Quality Assurance, Registered Quality Professional - GLP - RQAP-GLP).
Other:
+ Up to 30% travel, domestic and international, required.
+ The anticipated base pay range for this position is $99,000 to $170,200.
+ In the California Bay Area - The anticipated base pay range for this position is $113,000 to $195,730.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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.
+ Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
+ Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
+ Employees are eligible for the following time off benefits:
+ Vacation – up to 120 hours per calendar year
+ Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
+ Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
+ Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
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.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Primary Location NA-US-Ohio-Cincinnati
Other Locations NA-US-California-Santa Clara
Organization Auris Health, Inc. (6267)
Relocation Eligible: No
Travel Yes, 25 % of the Time
Job Function Quality Assurance
Req ID: 2406217771W
Source : J&J Family of Companies
