Compliance Manager - Alameda, United States - Abbott Laboratories

Description

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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

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 you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 is an onsite opportunity in the Abbott Diabetes Care Division. We are helping people with Diabetes lead healthier, happier lives. As a global leader in diabetes care, Abbott is constantly working to deliver the highest quality products and unwavering support to our customers. Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, so we're committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels.

As the Alameda Compliance Manager, you will set strategy for internal, clinical, and external audits (Regulatory Agencies, Corporate, Certification bodies, and major clients) ensuring Alameda and other ADC sites are audit ready at all times. The incumbent manages a team of auditors in Alameda and acts as a change leader, responsible for management of major global improvement activities to improve quality systems, audit readiness, and compliance.. 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. This is an onsite opportunity in Alameda, CA.

What You'll Do

• Manages a team of auditors responsible for 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 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.
• 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.
• Deploys Compliance/Regulatory Learning across the division. Provides advice on compliance to executive management and staff.
• 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

EXPERIENCE YOU'LL BRING

Required:

• Bachelors Degree
• Minimum 8 years of Quality Systems, Quality Assurance 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 IVDD, MDD, MDR, IVDR and applicable US Code of Federal Regulations CFR 803, 806 and 820, ISO 13485 and 14971.
• Minimum 5 years in a management capacity.

Apply Now

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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

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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Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM

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.

Diabetes

We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

Vascular

Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Neuromodulation

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Structural Heart

Structural Heart Business Mission: why we exist

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

EP

In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

HF

In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

Diagnostics

We're empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.

Abbott Molecular is a leader in molecular diagnostics and the analysis of DNA, RNA, and proteins at the molecular level.

Our Point of Care diagnostic portfolio spans key heath and therapeutic areas, including infections disease, cardiometabolic, informatics and toxicology.

Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.

Nutrition

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac, PediaSure, Pedialyte, Ensure, and Glucerna – to help them get the nutrients they need to live their healthiest lives.

The base pay for this position is $125,700.00 – $251, In specific locations, the pay range may vary from the range posted.