Staff Regulatory Compliance Specialist

Johnson & Johnson Innovative Medicine•San Jose, CA

About The Position

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 jnj.com. 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. Job Function: Legal & Compliance Job Sub Function: Enterprise Compliance Job Category: Professional All Job Posting Locations: San Jose, California, United States of America, Santa Clara, California, United States of America 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.

Requirements

A minimum of a Bachelors or equivalent University degree is 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, FDA’s GMP and QSR requirements for medical devices 21CFR part 11, 210, 211, 820, 803, 806, 807, Part 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.

Nice To Haves

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 Microsoft Project is preferred.
Experience with Minitab.
This position may require up to 10% domestic travel.

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
Participates in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME’s, 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
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.
Connects and collaborates with other region’s compliance teams.
Conducts audits at other sites as needed.
Creates reports and communicates performance against metrics to key stakeholders.
Highlights/communicates adverse trends in metrics, and take risk-based action to remediate.
Escalates items in accordance with established procedures.
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.
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.
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