形容
Johnson & Johnson is currently recruiting for a Director, Technology Compliance ! This position will be located in Raritan, NJ.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.
With $76.5 billion in 2017 sales, Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. There are more than 250 Johnson & Johnson operating companies employing over 125,000 people and with products touching the lives of over a billion people every day, throughout the world. If you have the talent and desire to touch the world, Johnson & Johnson has the career opportunities to help make it happen.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
Position Summary
The Head Technology Compliance is responsible for GxP Technology compliance strategy and operational excellence, including accountability for GxP System Periodic Review, Technology Services Internal Audit, Technology Supplier Audit, Audit Follow-Up, Standards Management, and Inspection Readiness and Support Programs. This position is responsible for working with internal business partners and Technology Suppliers to enable the development of corrective and preventing actions related audit and/or inspection findings and partners internally to develop compliance strategies that meet regulatory requirements. This individual also provides regulatory subject matter expertise related to existing and emerging technology areas. This position will partner with Technology Services, Technology Quality, and Sector stakeholders to ensure that J&J quality standards and global regulatory requirements are met and will ensure integration of new or changing regulations into the business, including monitoring of implementation status. This position owns and continuously improves compliance programs, including audits/assessments, health authority inspection readiness, and external regulatory outreach to shape emerging regulations in the areas of technology and innovative healthcare solutions.
Key Responsibilities:
· Defines strategies to move TRC towards a more positive risk management posture by utilizing knowledge of current and emerging regulations.
· Applies expert understanding of current and evolving regulations to continuously assess and evolve compliance programs and audit/assessment methods.
· Interprets Health Authority observations/guidance/enforcement trends to determine if changes are required to maintain the effectiveness of compliance programs.
· Translates compliance requirements into business and IT relevant terms for key stakeholders and gains support by articulating and promoting positive links between compliance and business impact.
· Maintains knowledge of business process area technology and strategic initiatives within span of responsibility and feeds that intelligence into risk assessment and risk management activities to prioritize audit/assessment scheduling and field work focus
· Drives the understanding of risk factors related to specific technologies and leads the development of tailored approaches for internal audit, GxP system Periodic Reviews, and supplier (software and technology service providers) evaluation to identify relevant risk scenarios.
· Understands JJRC, TQ&C, and JJT-Technology Services organizational strategies and integrates requirements into TRC G&O planning and roadmap to ensure alignment.
· Provides leadership and expertise in interpreting, evaluating, and classifying risk associated with audit findings.
· Coaches team on the planning/preparation, execution, and field work focus for audits/assessments.
· Provides leadership and support in the development of corrective action plans that systemically address the root cause of issues.
· Coaches and Leads team members in the execution of corrective action verification activities, including status reporting, in support of closed loop audit programs:
o Technology Services Internal Audits
o Technology Supplier Audits
o GxP Computerized System Periodic Reviews
o Health authority inspection commitments
· Escalates critical issues/risk to senior leadership and continuously improves program effectiveness.
Analyzes audit and other compliance data to identify trends and insights to drive proactive quality actions.
· Owns J&J Technology Services inspection readiness program, including J&J Operating Company support request intake process and response.
· Provides direct support to J&J Operating Companies globally during inspections, including preparation of technical subject matter experts to interface with regulators.
· Engages directly with health authority agencies during inspections.
· Supports the development and write-up of responses to Technology Services owned health authority observations.
Serves as Technology audit/assessment process subject matter expert during internal audits and external regulatory inspections.
· Interprets and communicates current and emerging regulations at a global level and continuously monitors the changing regulatory climate to proactively assess and communicate trends and emerging areas.
· Owns the Technology Services Standards Management Process to ensure new/changing regulatory requirements are quickly incorporated into the Quality Management System and/or operational processes. Partners with Technology Quality to execute gap assessments between current practices and new regulatory expectations, as communicated via health authority regulations, guidance, and enforcement trends. Works with Quality and other partners to establish corrective actions to address any identified gaps and independently monitors and reports on the status of implementation.
· Leads the development and submission of industry comments to proposed regulations and guidances.
Partners with JJRC-Enterprise Regulatory Outreach and owns strategic direction of Technology related regulatory outreach and associated activities to ensure alignment with business priorities
· Provides partnership, insight, and direction to cross-functional business leaders and stakeholders regarding TRC processes, capabilities, and initiatives.
· Serves as compliance partner to Technology and Technology Quality, providing base business advisory expertise and in the creation of compliance strategies that enable innovation in emerging areas.
· Establishes and drives sustainable Technology compliance programs for new technologies.
Creates and delivers regulatory compliance training and awareness programs to internal stakeholders.
· Supports strategies and practices to establish a continuous learning culture that supports talent capabilities, including future readiness and retention. This includes targeted technical and business process trainings, guided learnings, compliance retrospectives, new/changing regulatory Guidances/positions/enforcement trend debriefs, and allocation of talent with specific development/exposure goals (e.g. SaMD, Cybersecurity, etc.) for “ride along or second chair” as part of the Demand & Supply Intake Process.
· Contributes to talent pipeline efforts focused on identifying internal and external candidates with a niche skillset in compliance and technology for future TRC roles.
· Supports new talent on-boarding.
· Manages global teams across geographies including FTEs and Contractors within a matrixed organization.
· Responsible for the development of direct reports by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs.
· Provides an environment which encourages the company's credo, commitment to equal employment opportunity and the value of a diverse work force.
Conducts performance reviews, succession planning, talent reviews and career development for direct reports.
資格
Education:
A minimum of a Bachelors or equivalent University degree is required, Masters or Advanced degree preferred.
Required:
· 10+ years of progressive experience in Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment.
· Expert knowledge of Quality System regulations, ISO, ICH, PIC/S, and cGMP regulations, including Annex 11, 21 CFR Part 11, Part 210, Part 211 and Part 820, and how these apply to Computer Systems and software medical devices.
· Expert knowledge of Data Integrity requirements.
· Knowledge of medical device software requirements, including Digital Health, Software as a Medical Device (SaMD), and Mobile Medical Apps (MMaps)
· Expert knowledge of IT practices (e.g., ITIL), Software Development Lifecycle (SDLC) methodologies, and Cybersecurity.
· Functional experience working with medical device software.
· Proven experience effectively interfacing with global regulatory agencies during inspections, e.g., FDA, MHRA, TGA, notified bodies, etc.
· Ability to resolve complex regulatory compliance issues.
· Ability to analyze and interpret regulatory documents.
· Ability to develop strategy, build consensus, and drive outcomes without having direct line authority.
· Proven experience in driving progress to strategic plans and keeping team focused under ambiguous and complex situations.
· Ability to influence, negotiate, and build credibility to enable achievement of goals.
· Excellent written and oral communication skills, including ability to make technical and complex topics clear and easily understood.
· Ability to effectively present information to executive leadership.
· Ability to lead teams and build strong cross-functional relationships.
· Strong skills in interdependent partnering to facilitate collaboration.
Preferred:
· Experience in regulatory affairs areas, including knowledge of 510K and PMA submission process (or global equivalent).
· Experience in establishing Quality Management Systems.
Other:
· This position may require up to 25% domestic travel
· This position has an estimated annual salary of 142,000-284,000 USD$
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.