AddressDescription
Johnson & Johnson is recruiting for a Sr. Analyst, Technology Compliance in Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States. This position may require up to 10% travel.
Per our J&J Flex Policy, the expectation for this position is to work in the nearest Johnson and Johnson office 3-4 days per week and work from home 1-2 days per week.
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/.
The Senior Analyst, Technology Compliance is responsible for providing operational support for the execution of Enterprise Quality compliance programs.
This position is responsible for execution of closed loop audit and assessment programs, including Internal Audit, Supplier Audit, and GxP System Periodic Reviews associated with Enterprise Quality QMS . This position is also responsible for providing direct support to business segments during Health Authority and other Third-Party audits related to Technology areas;. This position assists in the continuous improvement of the compliance programs, including internal audit program for Enterprise Quality QMS elements and other technology areas
The Sr. Analyst, Technology Compliance will:
· Leads and executes closed loop periodic reviews of J&J Segment (Innovative Medicine, Med Tech and Enterprise) GxP computerized systems that are supported by Enterprise Quality including a large global portfolio of computerized systems covering Manufacturing and Laboratory.
· Leads and executes closed loop supplier audits, covering GxP related software and service providers, including suppliers of infrastructure as a service (IaaS), Platform as a service (PaaS), Software as a Service (SaaS)
· Assists in providing independent oversight of audit and assessment corrective actions, documenting results, reporting on follow-up status, escalating any identified risk, and assisting with the continuous improvement of the follow up program.
· Assisting Enterprise Quality and Business Quality groups to execute gap assessments between current practices and new regulatory expectations, as communicated via new health authority regulations, guidance, and enforcement trends. Works with Quality partners to establish corrective actions to address any identified gaps.
· Assists in the continuous improvement of Enterprise Quality compliance programs associated with remediation follow-up activities for new regulation gap closure; health authority observation commitments; internal audits; supplier audits; and computerized system periodic reviews.
· Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders to accomplish business objectives.
· Maintain awareness of new and emerging technologies and regulatory requirements
· Ensure awareness of industry standards, trends and best practices in order to strengthen GxP knowledge.
· Participates in industry and other professional networks to ensure awareness of industry standards, trends and enforcement actions in order to strengthen compliance programs. Engages with industry groups (e.g., ISPE, AdvaMed) to shape the external regulatory environment.
· Ensures timely and effective support is provided to J&J Operating Companies globally, including working with inspection site leadership to understand Enterprise Quality related inspection requests and preparing subject matter experts to speak with investigators.
· Engages directly with health authority inspectors from regulatory agencies and assists/accompanies subject matter experts to engage with regulators as needed.
· Assists with the timely reporting of status and metrics as required by the Regulatory Compliance organization.
· Ensures timely completion of assigned training.
· Actively engage and/or lead projects within the EQ organization.
Qualifications
Requirements:
· A bachelor’s degree is required, preferably in Science, IT, Quality, Mathematics, Engineering or Business Administration; a graduate degree is preferred
· 4+ years of experience in managing all aspects of Quality and Regulatory Compliance in an international, global context, in a regulated healthcare environment
· Experience in information systems and/or GxP auditing within Pharmaceutical/Medical Device company or minimum of 2 years of direct experience with GxP Quality Assurance, development, implementation and/or validation of computerized systems within Pharmaceutical/Medical Device company.
· Experienced 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.
· Experienced knowledge of GMP Manufacturing QA, GAMP5, data integrity requirements.
· Demonstrated experience in writing compliance documentation
· Ability to analyze and interpret regulatory documents.
· Excellent verbal and written communication skills
· Strong skills in interdependent partnering to facilitate collaboration.
· Ability to work effectively in a virtual team environment.
· Analytical mindset
Preferred:
· Expertise in medical device software quality requirements, including standards for medical device software development and risk management preferred.
· Experience working with Quality Management Systems.
· Auditor experience. 2+ years of experience with auditing, Risk Assessment and Management and Nonconformance/CAPA system in a regulated industry, preferably HealthCare Industry
· Audit management and delivery
· In-depth and up-to-date compliance knowledge
· Audit logistics coordination Data analysis and reporting
The base pay range for this position is $76,000 - $121,900.
This job posting is anticipated to close on May 24, 2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
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)).
This position is eligible to participate in the Company’s long-term incentive program.
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
- Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
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 .
