Staff Regulatory Compliance Specialist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

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Job Description:

Johnson & Johnson is currently recruiting a Staff Regulatory Compliance Specialist! This position can be located in Santa Clara or San Jose California.

Position Summary:

The Staff Compliance Engineer (Senior Analyst Enterprise Compliance) will support maintain and lead when necessary the Internal Audit Program to help the site sustain a state of readiness to applicable regulatory requirements. Leads and maintains the assigned Compliance functions to ensure compliance to applicable regulations and directives such as 21 CFR 820 21 CFR 4 ISO 13485/EN ISO 13485 ISO 14971/EN ISO 14971 European Medical Device Directive and European Medical Device Regulation Canadian Medical Devices Regulations SOR/98-282 ANVISA Technical Regulations of Good Manufacturing Practices of Medicinal Products and In Vitro Diagnostic Products Resolution RDC 665 Japan Ministry of Health Labour and Welfare of Japan Ordinance No. 169 Australia Therapeutic Goods (Medical Devices) Regulations and any other regulations or standards applicable to the site.

Participates in site internal audits as a team or lead auditor to ensure compliance with all applicable quality system standards and directives in accordance with the internal audit schedule. Leads inspection readiness activities and actively participates in conduct of external quality system audits and inspections. Supports preparation of external audit and inspection responses. lead compliance projects/initiatives at the sites and serves on cross-site project teams consistent with company goals and objectives to improve overall compliance performance to established metrics and requirements. Manages assigned internal and external audit observations to ensure identified gaps are closed in a timely manner.

Key Duties & Responsibilities:

External inspection readiness and associated activities. Support site audit readiness activities to ensure inspection readiness at all time.

• Supports external audits and mock inspections: e.g. Notified Body Ministry of Health country inspections FDA State Inspections J&J Corporate Audits for site.
• Executes site inspection readiness actions/tools o Participates in audit preparation activities (auditor logistics front room/back room arrangements identifying/preparing SMEs etc.).
• Assesses the risk and applicability of audit observations from other J&J facilities to determine impact to the site.
• Provides timely information to support the inspection process

Internal Audit Program and Management Execution o Executes internal audits as a team or lead auditor against established internal audit procedures.

• Ensures adequate corrective actions for internal audits including investigations and corrective action plans drive on-time completion of observation action plans perform follow-up with observation owners and perform effectiveness monitoring and closure.
• Drives compliance and improvement in audit metrics.

Enterprise / Sector Support o Connects and collaborates with other regions compliance teams.

• Conducts audits at other sites as needed.

Metrics Collection and Reporting

• Creates reports and communicates performance against metrics to key stakeholders.
• Highlights/communicates adverse trends in metrics and take risk-based action to remediate.

Escalations

• Escalates items in accordance with established procedures.

External Standards and Regulations o Supports implementation of new external standards/regulations for the site.

• Maintains current knowledge of regulatory changes through industry publications seminars professional affiliations and industry meetings.

Site Management Review and Quality Reviews

• Provides input (e.g. internal and external audit results/status) into Management Reviews Data Review Boards and other quality reviews to allow meaningful review as needed.
• Participates in reviews as required.

Other tasks

• Establishes strong connection and collaboration with business partners at the site.
• Provides compliance education and training (QSR ISO GMPs) to the organization in support of overall educational strategies as needed.
• Supports and promotes the safety and environmental objectives of the facility as required. Comply with all environmental safety and occupational health policies (i.e. ISO14001 & OSHAS 18001).
• Complies with all job specific safety procedures and utilize PPE when necessary.
• Ability to create an environment that fosters creativity and calculated risk-taking (within established compliance parameters).
• Advanced level of complexity management.
• Effectively cope with change and accomplish business results with minimal direction.
• Participates in the recruitment and development of staff or other identified associates.
• Impacts people and inspires all levels to use innovative methods to produce desired business results.
• Works within a team environment; behaving in a CREDO-based respectful manner. Advocates and fosters teamwork within the organization.
• Complies with all federally regulated programs. Complies with quality system requirements as defined within procedures and instructions.
• Utilizes applicable software systems as needed for the job (e.g. ComplianceWire ADAPTIV etc.)
• Supports LEAN Six Sigma and 6S Initiatives.
• Accurately completes records as defined within the job procedures (e.g. manual and/or electronic documentation).
• Consistently meet required Training due date targets.
• Utilizes electronic systems and software tools.
• Manages spending to meet departmental budget. Submits capital appropriations and manage departmental projects.
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
• For those who supervise or manage a staff 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 if applicable
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures
• Performs other duties assigned as needed

Qualifications:

Education:

A minimum of a Bachelors or equivalent University degree is required.

Required:

• 6 8 years or more experience in a FDA regulated industry (pharmaceutical or medical devices) or another highly regulated industry.
• Experience leading internal quality system audits.
• Position requires proven leadership skills in associate involvement and teamwork initiative creativity assertiveness attention to detail and excellent interpersonal skills.
• Ability to work under pressure achieving consistently high results in quality efficiency and compliance through individual and team efforts.
• Ability to analyze complex data and integrate multi-disciplinary feedback.
• Excellent communication and interpersonal relation skills.
• Expertise on the new Quality System Regulations with the ability to relate these real live issues.
• Proven ability to initiate and implement Quality System changes.
• Knowledge of quality and manufacturing systems & processes and applicable regulations (ISO 13485 MDD 93/42/EEC and amendments MDR ISO 14971 FDAs GMP and QSR requirements for medical devices 21CFR partPart 4 Therapeutic Goods (Medical devices) Regulations ANVISA Resolution RDC 665 CMDR SOR 98-282 Japan MHLW Ordinance No.169 and other applicable regulations standards)
• Knowledge of Microsoft Office (Word Excel PowerPoint and Outlook) is required. Experience with Microsoft Project is preferred.

Preferred:

• Experience in Quality Manufacturing or Engineering roles.
• Experience leading or managing an internal audit program.
• Advanced computer and database management skills.
• Statistical and analytical problem solving.
• Current Certified Quality Audit (CQA) Certified Biomedical Auditor (CBA) and/or Lead Auditor certification.
• Strong Project management skills experience in leading and managing projects and milestones.
• Training in Process Excellence/Six Sigma tools and methodologies and Certification preferred.
• Experience with Minitab.

Other:

This position may require up to 10% domestic travel.

Johnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

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