Regulatory Compliance Manager
Company: Disability Solutions
Location: Irving
Posted on: May 3, 2024
Job Description:
Johnson & Johnson Family of Companies is recruiting for a
Regulatory Compliance Manager! This position will be located in
Irving, TX. Mentor Worldwide, LLC, a member of Johnson & Johnson's
Medical Devices Companies, is recruiting for a Regulatory
Compliance Manager for our Irving, Texas location! Mentor is a
leading supplier of breast implants in the global aesthetic market.
The company develops, manufactures, and markets innovative,
science-based products for surgical and non-surgical medical
procedures that allow breast surgery patients to improve their
quality of life. The company is focused on two strategic areas:
breast reconstruction and breast augmentation. MENTOR-- is the only
manufacturer whose silicone breast implants are made in the U.S.A.
For over 20 years, more than 5 million women have chosen MENTOR--
Breast Implants. Position Summary: Under the management of the
Regulatory Compliance Director CSS this position will have the
objective of maintaining high quality standards for the product
manufacturing process and compliance with all applicable regulatory
requirements. In addition, this position is responsible for the
absence of significant quality issues and regulatory compliance
actions by government agencies. Replaces in case of absence:
Regulatory Compliance Director CSS ; as duties as assigned. Under
general direction and in accordance with all applicable federal,
state and local laws/regulations and Corporate Johnson & Johnson,
procedures and guidelines, this position: External inspection
readiness and associated activities.
- Lead and manage site audit readiness activities to ensure
inspection readiness at all time
- Prepare and host external audits: e.g. Notified Body, Ministry
of Health country inspections, FDA, J&J Corporate Audits for
site. Responsible for effective regulatory agency inspections.
- Audit preparation activities (auditor logistics, front
room/back room arrangements, identifying/preparing SME's,
etc.).
- Assess the risk and applicability of audit observations from
other J&J facilities to determine impact to the site.
- Schedule and manage mock inspections as part of External
Inspection Readiness activities.
- Provide timely information to support the inspection process,
including those that maybe taking place at other sites /
locations.
- Provide daily inspection communications regarding potential
non-conformities.
- Prepare responses to any external inspection or other
regulatory notification associated with site.
- Ensure adequate corrective actions for external audit
observations related to site, including investigations, monitor and
drive on-time completion of CAPA plans, perform follow-up with CAPA
owners, and perform effectiveness monitoring and closure. Internal
Audit Program and Management Execution:
- Curriculum and Proficiency Establish and execute an effective
internal audit schedule for site.
- Execute against established internal audit procedures.
- Ensure adequate corrective actions for internal audits,
including investigations and corrective action plans, drive on-time
completion of CAPA plans, perform follow-up with CAPA owners, and
perform effectiveness monitoring and closure
- Drive compliance and improvement in internal audit
metrics.
- Ensure quality system is periodically evaluated and audited and
appropriate preventive/ corrective action is taken to meet the
business and regulatory requirements.
- Where appropriate, execute program(s) for training and
evaluating qualifications of auditors. Note: Programs can include
franchise, supply chain, sector, and/or enterprise elements.
Enterprise / Sector Support
- Participate in JJRC audits as requested.
- Where appropriate assure representation on all required
business unit, sector, and/or enterprise teams (e.g., Do it
Right)
- Support the creation and effective deployment of internal
J&J Quality System and/or Compliance standards.
- Connect and collaborate with CSS Regulatory Compliance team and
other regions. CURVE Reporting
- Assure that required compliance-related events (e.g., field
actions, inspections) are entered into CURVE per required
timeframes.
- Assure that CURVE information is current and updated in a
timely manner. Metrics Collection and Reporting
- Assure that Quality & Compliance metrics are consistently and
accurately captured, and that metrics are captured at the
appropriate level for subsequent analysis and reporting (e.g., site
level, supply chain).
- Drive compliance to Quality and Compliance metric targets.
- Create reports and communicate performance against metrics to
key stakeholders.
- Highlight/communicate adverse trends in metrics and take
risk-based action to remediate. Escalations
- Escalate items in accordance with established procedures.
- Provide routine communication, updates and escalation to site
and franchise organizational management regarding compliance trends
and initiatives.
- Responsible for the proactive identification and alerting of
management of quality
- issues in time to resolve potential adverse effects to the
customer, company image/reputation and/or the business. External
Standards and Regulations
- Proactively assess and influence the external environment by
participating on industry and regulatory body work teams. As
appropriate collect and provide site input.
- Communicate outcomes and trends to key stakeholders.
- Support implementation of new external standards/regulations
for Supply Chain Sites.
- Maintain current knowledge of regulatory changes through
industry publications, Site Management Review
- Provide input into Site Management Reviews (e.g., internal
audits.) to allow meaningful review. Other tasks
- Proactively communicate organizational and compliance
procedure/ policy related changes that may impact sites. Ensure
feedback and alignment with said changes.
- Establish strong connection and collaboration with business
partners at the site, e.g.
- Quality Operations, Training, Manufacturing.
- Provide compliance education and training (QSR, ISO, GMPs) to
the organization in support of overall educational strategies.
- As appropriate, perform annual performance appraisals for
identified associates.
- Establish objectives and development plans for direct
reports
- Support and promote the safety and environmental objectives of
the facility
- Responsible for communicating business related issues or
opportunities to next management level
- 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
Keywords: Disability Solutions, Mesquite , Regulatory Compliance Manager, Executive , Irving, Texas
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