Sr. Compliance Manager

Location: California
Sr. Compliance Manager page is loaded## Sr. Compliance Manager locations:
United States - California - Sylmartime type:
Full time posted on:
Posted Todayjob requisition :
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.##
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* JOB DESCRIPTION:

**** Job Title
**** Compliance Manager
**** Working at Abbott
** At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
* Career development with an international company where you can grow the career of which you dream.
* Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
* An excellent retirement savings plan with high employer contribution
* Tuition reimbursement, the  student debt program and  education benefit - an affordable and convenient path to getting a bachelor’s degree.
* A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
* A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
** The Opportunity
** This position works out of our Sylmar, CA location.
** This is an onsite role**.Sets strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring sites are audit ready at all times.

The incumbent manages a team of auditors across the sites and acts as a change leader, responsible for management of major global improvement activities to improve quality systems, audit readiness, and compliance.

Represents the division within Abbott through Corporate based advocacy forums as well as external Regulatory Intelligence Forums such as the Notified Body Audit Coordination Committee (NBACC);
Clinical Audit Forums, Compliance Council.

The incumbent uses knowledge gained from audits, assessments and advocacy forums to share with management the compliance health of the division, they participate in strategies to improve compliance where improvements can be identified.

Heads the Compliance Lifecycle Program, or similar programs within the division, establishes effectiveness criteria and advises Executive Management on compliance and audit readiness. As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
** What You’ll Work On
*** Manages a team of audit readiness SMEs responsible for representing BU in auditing/assessing the relevant entities to ensure compliance with Abbott policies and procedures, worldwide regulations and industry standards relating to the development, manufacture, and distribution of the products and services it provides to assure effectiveness and safety of Abbott products.  Relevant entities include divisional sites, Clinical sites, Commercial Affiliate sites, and Third Party Manufacturers and Suppliers
* Development of department strategy for auditing of regulated activities and proactive strategic planning and resource allocation to ensure appropriate department  audit support aligned to quality and regulatory requirements and business needs.
* Acts as main external regulatory body interface for US. Directs / manages internal and external inspections / audit strategies across US site.
* Acts as Subject Matter Expert for Audit in Inspections and Internal/External Audits
* Directs audit management, staffing, and logistics and allocates roles and responsibilities prior, during and post audit. Review and approve audits performed by direct reports and auditing team
* Division owner of the Quality Audit reporting IT Systems. Process Owner delegate for Management Responsibility…