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 Freedom 2 Save student debt program and FreeU 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 across sites.
• Directs the US readiness program, including risk prioritization & mitigation.
• Evaluates published Regulatory Agency (e.g. FDA) guidance, changes to external standards, actions and audit findings to assess impact and take action to mitigate risk to the business.
• Evaluate trends from available sources to provide perspectives on recent audit findings in related industries or Abbott as a whole.  From this trending provide a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
• Provide QA leadership to the GAP assessment and mitigation programs for regulatory policy changes & emerging regulation. Works in partnership with the division and AQR leadership teams to identify risks to the business and proposes solutions to regulatory and quality issues across.
• Improves Regulatory communication and documentation and deploys Compliance/Regulatory Learning across the division.  Provides advice on compliance to executive management and staff.
• Establishes solid relationship with TUV/BSI/FDA and other regulatory agencies.  Liaison to AQR’s External Standards Database, AQR’s Consultant Pool, AQR’s Quality Actions Program, Strategy & deployment of an audit compliance program.
• Represents the division on Quality Audit Council. Lead and participate on QA cross-functional teams to support the Abbott Corporation and Division as necessary. Maintain an understanding and sensitivity to the business climate and relationship while implementing quality initiatives and resolving quality problems
• Note: This job description describes the principal and main elements of the job.
• It is a guide to the nature and main duties of the job as they currently exist, but is not intended as a wholly comprehensive or permanent representation

EDUCATION AND EXPERIENCE YOU’LL BRING 

• Bachelor’s degree
• Minimum 8 years experience of Quality Systems, Quality Assuance and/or Regulatory Compliance/Affairs experience in In Vitro Diagnostics and medical device manufacturing or other similarly regulated environment.
• Knowledge of regulations and standards Such as IVD, MDD and applicable US Code of Federal Regulations CFR 803, 806 and 820, ISO 13485 and 14971. 
• 5 years in a management capacity.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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