In this role you will be responsible to manage a Compliance team at several Depuy Synthes Sites in the DACH region to achieve a compliance framework that focuses on oversight and execution in a systematic way to enable proactive compliance success in delivering business needs across operating units.Your will be required to provide leadership, oversight, and strategic guidance for RC issue for the team and site the compliance manager is responsible for. Collaborate with US and OUS compliance team to standardize and leverage compliance intiatives, practices and metrcis across the organization.Enable successful product realization and compliance through readiness compliance activities, assesments and other consultation. Be the POC and provide lesdership / oversight of inspection readiness, audit management, and responses for internal and external inspection.
Responsibilities
Manage a compliance team to reach GO Compliance goals and objectives.
Lead and Support Internal audit efectivenesss program.
Lead and Support the inspection readiness program.
Create good relationship and partnership with business partners
Be the point of contact for Notify Body
Support site external Inspection (Provide assistance in Front Room/Back Room during External Audit)
Act as Suject Matter Expert on Internal Audit process for any site External Inspection.
Provide Guidance and support in site response, when applicable, for 3rd party, Notify body or corporate inspection.
Assess compliance in Failure Investigation and Root Cause identification
Assess Action plan and Effectiveness Monitoring adequacy.
Inform Local/Regional Management accordingly
Track 3rd party, notify body or corporate inspection commitments timeliness and inform regularly local/regional management accordingly
Work effectively within the OUS and US compliance teams
Work effectively with Site Business Partners
Qualifications
Graduate degree/studies in science, business, engineering or organizational management or equivalent experience strongly preferred
Equivalent degree and/or adequate associated work experience is acceptable
Experience is leading Internal Audit
Experience in Medical Device Company or Pharma company
Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment
At least 6-8 years working experience in a regulated industy
At least 3-5 years experience in a quality and/or compliance function
Experience in leading internal audits is required
Experience with External inspection is required
Experience in managing and/or in performing audits in a FDA or similar regulated environment or in a Notified Body environment associated with medical devices or pharmaceuticals
Experience with People Management
Excellent organizational and communication skills (written and verbal)
Excellent soft skills when working with others up, down and sideways within DepuySynthes, with consultants and with suppliers
Strong influencing skills and solid experience in working in matrix structures
