Compliance Specialist
Location:
West Chester , Pennsylvania
Posted:
January 05, 2017
Reference:
1391161201-en-us

DePuy Synthes Companies is a member of Johnson & Johnson's Family of Companies, and is recruiting for a Compliance Specialist located in West Chester, PA.

 

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.

 

The Compliance Specialist will have direct contribution to the execution, oversight and approval of compliance strategies required to remediate self-identified compliance risks and observations from audits/inspections in supporting but not limited to the Synthes US sites.  The candidate must be driven to mitigate risks, eliminate recurrence, and ensure appropriate deliverables are met per defined process. This will include maintaining base business compliance for all internal and external audits and supporting continuous readiness activities

 
POSITION DUTIES & RESPONSIBILITIES:

Continuous Improvement Focus - Drive Compliance improvements, which result from internal audits, Quality Board Issues and other system indicators.

Support  required audits in accordance with defined procedures and the master schedule

Assist in tracking of internal audit reporting, response review and approvals, communication of issues, and use of tracking and trending tools.

Provide audit results to management and coordinate audit CAPA/OBS actions.

Support  regulatory inspection readiness plans for US sites.

Develop, maintain and report the trends associated with all aspects of the Auditing (internal/external)

Partner effectively with the other site engineers/ specialist to ensure consistent systems.

Support other areas of the business as required e.g. Data Management/ DHR review/complaint management etc.

Create and maintain weekly Compliance Report  outs across the Synthes US sites- ex. Deep Dive Dashboard

Assist DePuy Synthes to deploy IR  tools to prepare sites for external audits

Complete Compliance Walkthrough- Gemba Walks (partnering with Quality Operations

Assist and/or conduct investigations into potential quality/compliance concerns. Keep management informed of issues.

·         Stay current on applicable FDA, ISO (including risk management), and other applicable industry requirements. Monitor external publication sources for issues applicable to DePuy Synthes.

·         Provide consulting service to site and corporate personnel.

·         Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.

·         Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

·         Promote and nurture the highest standards of professionalism, ethics and compliance, and actively support our compliance program-related initiatives and activities.

·         Consistently enforce employee compliance, including attendance at training programs, and promptly report any non-compliance to the Chief Compliance Officer.

·         Perform all other duties as assigned.

 


Qualifications

Required Qualifications:

  • A minimum of an Associate’s degree  
  • A minimum of 2-4 years’ experience in quality/compliance in the medical device and/or pharmaceutical industries or a medium to large scale matrix organization in a regulated environment
  • Direct contact/interaction experience with the FDA, ISO registrars and other notified bodies
  • Knowledge of regulatory compliance and health authority regulations, preferred in pharmacovigilance area.
  • Ability to independently plan, organize, coordinate, manage and execute assigned tasks.  Can utilize appropriate initiative and autonomy in achieving objectives; works independently with minimal supervision.
  • Strong analytical skills to examine data and perform analysis
  • Computer skills: must be proficient using databases, excel, building PowerPoint and software programs. 
  • Ability to translate data into information and actionable tasks.
  • Ability to identify, troubleshoot and implement effective solutions.
  • Must be able to effectively and constructively manage conflict and resolve issues and escalate appropriately.
  • Must be highly organized and able to multi-task and track multiple concurrent, ongoing activities in a timely manner.


Preferred Qualifications:

  • Bachelor of Science (BSc) or Arts (BA)
  • Process knowledge in CAPA, Audit, or Document Control management including investigation and root-cause analysis.
  • Experience working with Manufacturing, Product Development and Corporate functions
  • Auditor Certification, such as ASQ CQA 
  • Experience performing audits in the medical device and/or pharmaceutical industry
  • Documented training in FDA Quality System Regulation (QSReg), ISO 13485, Medical Device Directive


Primary Location
United States-Pennsylvania-West Chester
Organization
Depuy Orthopaedics. Inc. (6029)
Job Function
Compliance

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