SENIOR MANAGER, CYBERSECURITY QUALITY AND DATA INTEGRITY

Johnson & Johnson Services Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Senior Manager, Cybersecurity Quality and Data Integrity.
  The primary and preferred location for this position is Raritan, NJ.  (Consideration may be given for candidates located in New Brunswick, NJ, Raynham, MA, Irvine, CA, or Horsham, PA.) 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.
nj.
om/.
Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J.
TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.
The Senior Manager of Cybersecurity Quality & Data Integrity is responsible for designing and implementing fit-for-purpose quality and compliance strategies and programs in the specialized technical areas of regulated product (Medical Device) Cybersecurity and GxP Data Integrity.
This position will serve as the quality partner to J&J Information Security Risk Management.
This leader provides quality systems oversight of medical device and non-medical device cybersecurity, as well as security controls supporting data integrity, and collaborates with key senior business partners within the Information Security Risk Management (ISRM) Function and across J&J MedTech and J&J Innovative Medicine Quality organizations globally to sustain risk management and strong compliance posture in these critical regulatory areas.
As the Quality Subject Matter Expert for Cybersecurity and GxP Data Integrity, this individual provides leadership oversight and guides project and security teams through the QMS requirements associated with cybersecurity including, but not limited to, design, threat modeling, security testing, and vulnerability monitoring.
This position will partner with Information Security Risk Management, JJT-Technology Services, Technology Quality, and Business Sectors to ensure that J&J quality standards and global regulatory requirements are met and will support integration of new or changing regulatory requirements into the JJT-TS QMS.
Key Responsibilities.
Provides quality systems oversight of medical device and non-medical device cybersecurity, as well as security controls supporting data integrity, and collaborates with key senior business partners within the Information Security Risk Management (ISRM) Function and across J&J MedTech and J&J Innovative Medicine Quality organizations globally to sustain risk management and strong compliance posture in these regulated areas.
Understanding and interpreting global regulatory expectations and providing direction and guidance related to pre and post-market cybersecurity requirements and GxP data integrity, including emerging associated frameworks (e.
., NIST CSF and ISO family).
Maintaining knowledge of strategic product and non-product cybersecurity initiatives and innovation programs across J&J globally and serving in a quality strategy advisory capacity in the development of compliant pathways that meet regulatory requirements.
Guide and train project teams to ensure security and data integrity requirements are understood and implemented, including leading inspection readiness related to these technologies.
Support incident management, root cause investigations, CAPA (Corrective Action Preventive Action), and audit/inspection observation response and action plans.
Guides and train project teams to ensure security and data integrity requirements are understood and implemented, including leading inspection readiness related to these technologies.
Engages directly with health authority agencies during inspections.
Supports other JJT-TS Quality Management System related processes and duties as needed.
Mentors talent and helps them grow in their careers.
Qualifications        Bachelor’s degree is required.
Minimum of 8 years of progressive experience in the pharmaceutical/med tech/biotech industry, with direct experience in IT, Quality, and/or Cybersecurity is required.
Strong knowledge of global cGMP regulations is required.
Understanding and interpreting global regulatory expectations and providing direction and guidance related to pre and post-market cybersecurity requirements and GxP data integrity, including emerging associated frameworks (e.
., NIST CSF, ISO family etc.) is required.
Ability to adapt and thrive in a rapidly changing IT regulatory environment and to define white space is required.
Ability to take on leadership roles within industry groups (e.
., ISPE, AdvaMed) to influence the external regulatory environment and to serve as a subject matter expert to J&J Sectors and Functions is required.
Experience applying comprehensive knowledge of current and emerging regulatory trends to develop and implement strategies that enable compliant innovation is required.
Ability to influence upwards and across to ensure compliance and regulatory requirements are met is required.
Excellent oral and written communication skills, including the ability to make highly technical and complex topics is required.
Experience providing regulatory expertise and influencing decisions in Steering Committees, Advisory Boards and other relevant forums is required.  Experience identifying risks and trends and gaining alignment from business and IT partners for proactive risk mitigation strategies is required.
Ability to build strong cross-functional relationships is required.  Experience effectively presenting information to executive leadership and/or in external forums is required.
The primary and preferred location for this position is Raritan, NJ, and may require up to approximately 10% travel.  (Consideration may be given for candidates to be located in New Brunswick, NJ, Raynham, MA, Irvine, CA, or Horsham, PA.) 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.  The anticipated base pay range for this position is $ to $.
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.
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 •              Holiday pay, including Floating Holidays – up to 13 days per calendar year •              Work, Personal and Family Time - up to 40 hours per calendar year For additional general information on Company benefits, please go to.
- https://www.
areers.
nj.
om/employee-benefits.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
This job posting is anticipated to close on .  The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.